L’augmentation de la population âgée dans la société indique que les systèmes de soins de la santé font face à de nouveaux défis. Les hauts niveaux d’incapacité qui en résultent peuvent être réduits par les nouvelles technologies, la promotion de la santé ainsi que des stratégies de prévention. Les écrits scientifiques récents soulignent la supériorité des prothèses dentaires implanto-portées par rapport aux prothèses conventionnelles en termes de satisfaction et de qualité de la vie des patients. Cependant, il n'est toujours pas clair si ces avantages ont des effets positifs à long terme sur la santé orale et générale ainsi que sur la qualité de vie des populations âgées. Objectifs, Hypothèses : Notre but était de mesurer l’impact des prothèses mandibulaires retenues par 2 implants sur la qualité de vie associée à la santé bucco-dentaire et générale ainsi que sur la santé orale et la qualité du sommeil des aînés édentés. Nous avons évalué les hypothèses nulles suivantes : il n'y a aucune différence entre les individus portants des prothèses mandibulaires retenues par 2 implants (IODs) et ceux qui portent des prothèses conventionnelles (CDs), par rapport à la qualité de vie reliée à la santé bucco-dentaire et générale, la santé orale et la qualité du sommeil, un an après avoir reçu leurs nouvelles prothèses. Méthodes : Dans cette étude randomisée contrôlée, 255 aînés ont reçu au hasard IODs ou les CDs, les deux types de prothèses étant opposés à des prothèses maxillaires conventionnelles. La qualité de la vie reliée à la santé bucco-dentaire (OHRQoL) et la santé générale subjective ont été mesurées avec les questionnaires Oral Health Impact Profile (OHIP-20) et Short Form-36 (SF-36) en condition pré-traitement et après un an. La qualité du sommeil et la somnolence diurne ont été mesurées à l’aide du questionnaire Qualité de Sommeil de Pittsburg et de l'Échelle de Somnolence Epworth. La santé orale a été évaluée par un examen clinique. Les variables indépendantes étaient le sens de cohérence et le type de prosthèse, ainsi que des variables socio-démographiques. En utilisant des analyses statistiques bi et multi-factorielles, des comparaisons à l’intérieur d’un même groupe et entre deux groupes ont été effectuées. Résultats : Les différences pré et post traitement pour les cotes OHIP étaient significativement plus grandes pour le groupe IOD que le groupe CD (p<0.05). Le type de traitement et la cote pré-traitement étaient des facteurs significatifs à OHRQoL (p < 0.0001). Dans le groupe CD, il y avait une diminution significative par rapport aux cotes de «Physical Component Scores (PCS)», le fonctionnement physique, le rôle physique et la douleur physique entre les données pré-traitement et un an après le traitement, ce qui indique une diminution au niveau de la santé générale subjective. Dans le groupe IOD, une diminution statistiquement non significative a été remarquée par rapport à toutes les cotes des sous-échelles de SF-36, sauf pour la douleur physique. Le modèle final de régression a démontré qu’après ajustement pour les variables âge, sexe, statut marital et type de traitement, la cote totale finale d’OHIP et les données de bases de PCS prédisaient la cote finale de PCS (p < 0.0001). Aucune corrélation significative entre sens de cohérence et OHRQoL n'a été détectée (r =-0.1; p > 0.05). Les aînés porteurs des prothèses conventionnelles avaient presque 5 fois plus de chance d’avoir une stomatite prothétique que ceux portant des prothèses mandibulaires hybrides retenues par 2 implants (p < 0.0001). Les aînés ayant subjectivement une mauvaise santé générale avaient une qualité de sommeil moins bonne que ceux avec une meilleure santé générale subjective (p < 0.05). Les personnes qui avaient une OHRQoL moins bonne étaient presque 4 fois plus somnolentes pendant le jour que celles avec une meilleure OHRQoL (p=0.003, χ2; OR =3.8 CI 1.5 to 9.8). L'analyse de régression a montré que la santé générale subjective et OHRQoL prévoient la qualité du sommeil (p=0.022 et p=0.001, respectivement) et la somnolence diurne (p=0.017 et p=0.005, respectivement). Conclusions: Les résultats de cette étude suggèrent que, chez les aînés édentés, des prothèses mandibulaires hybrides retenues par deux implants amènent une amélioration significative de la qualité de vie reliée à la santé bucco-dentaire et maintiennent la sensation d’une meilleure santé physique. Des prothèses hybrides implanto-portées peuvent contribuer à la santé orale en réduisant les traumatismes infligés à la muqueuse orale et en contrôlant la stomatite prothétique. Les aînés édentés dont le niveau de qualité de vie reliée à la santé bucco-dentaire est bas, peuvent aussi avoir des troubles de qualité du sommeil. / The global greying of society indicates that health care systems face new challenges. High levels of disability can be reduced through new technologies, health promotion and preventive strategies. Recent literature has underlined the superiority of mandibular implant overdentures over conventional dentures for patient satisfaction and quality of life. However, it is still not clear whether this benefit has any long-term positive effects on oral and general health, as well as on the quality of life of elderly populations. Objectives, Hypotheses: We aimed to measure the impact of mandibular two-implant overdentures on the general and oral health quality of life, as well as on oral health and sleep quality of edentulous elders. We tested the null hypothesis that there is no difference in the general and oral health quality of life, as well as, on oral health and sleep quality of those wearing mandibular two-implant overdentures (IODs) and those who wear conventional dentures (CDs), one year following prosthesis delivery. Methods: In this randomized controlled trial, 255 elders randomly received IODs or CDs, both opposed by conventional maxillary dentures. OHRQoL and perceived general health were measured with the Oral Health Impact Profile (OHIP-20) and the Short Form-36 (SF-36) at baseline and after one year. Sleep quality and daytime sleepiness were measured with the Pittsburg Sleep Quality global score and the Epworth Sleepiness Scale. Clinical exams were conducted to evaluate oral health. Independent variables included sense of coherence and prosthesis type, as well as socio-demographic variables. Between and within group comparisons were performed using bivariate and multivariate statistical tests. Results: Pre/post treatment differences in OHIP scores were significantly greater for the IOD than the CD group (p<0.05). Type of treatment and pre-treatment scores were significant contributors to OHRQoL (p<0.0001). In the CD group, there was a statistically significant decrease in physical component scores (PCS), physical functioning, role physical and bodily pain from baseline to one year follow up, indicating decreased perceived general health. In the IOD group, no statistically significant decrease was seen in SF-36 subscale scores from baseline to one year, except for bodily pain. The final regression model demonstrated that, after controlling for age, sex, marital status and type of treatment, the OHIP total final and the PCS baseline scores predict PCS final scores (p<0.0001). No significant correlation between sense of coherence and OHRQoL was detected (r= -0.1; p> 0.05). Elders wearing conventional dentures were almost 5 times more likely to have denture stomatitis than those wearing mandibular two-implant retained overdentures (p < 0.0001). Elders with low perceived general health had poorer sleep than those with high perceived general health (p<0.05). Those with low oral health related quality of life were almost 4 times sleepier during the day than those with high OHRQoL (p=0.003, χ2; OR =3.8 CI 1.5 to 9.8). Regression analysis showed that perceived general health and OHRQoL predict sleep quality (p=0.022 and p=0.001, respectively) and daytime sleepiness (p=0.017 and p=0.005, respectively). Conclusions: The results of this study suggest that, in edentulous elders, mandibular two-implant overdentures provide significant improvement in oral health related quality of life and maintain perceived physical health. Implant overdentures may contribute to oral health by reducing oral mucosa trauma and control denture stomatitis. Edentulous elders whose oral health related quality of life is low may also have poor sleep quality.

Essai cinique randomisé / Objectifs : Démontrer la supériorité de l’analgésie périopératoire optimale par rapport aux traitements analgésiques usuels ou conventionnels pour diminuer l'intensité de la douleur aiguë postopératoire (DAPO), la fréquence d'apparition de la douleur chronique post chirurgicale (DCPC) et améliorer la qualité de vie des patients. Méthodes : Un essai clinique randomisé à double insu, sur 57 patients ayant subi une trapéziectomie à l'hôpital Notre-Dame du CHUM. Après avoir reçu une analgésie locorégionale via un cathéter du plexus brachial, le groupe expérimental a reçu une perfusion de bupivacaïne 0,5%, débutée dans la salle de réveil et poursuivie pendant 72 h en ambulatoire, grâce à une pompe à perfusion. Le groupe de contrôle a reçu une solution saline. Les deux groupes ont reçu du célécoxib durant cette même période. L'évolution du profil de la douleur, du fonctionnement de la main et de la qualité de vie des patients ont été saisis à l'aide de questionnaires et de tests fonctionnels en préopératoire et pendant six mois de suivi. Les résultats ont été analysés à l'aide du modèle linéaire général. Une différence de 2 au niveau de l'intensité de la douleur, mesurée par l'échelle visuelle analogique (EVA : 0-10), a été considérée statistiquement significative. Résultats : Notre méthode a abouti à une diminution significative de l'intensité de la DAPO et de la douleur chronique (DC) par rapport à la méthode conventionnelle. Les activités générales, la qualité du sommeil et la concentration des patients étaient significativement meilleures chez le groupe qui a reçu la nouvelle méthode. De plus, dans ce groupe il y avait deux fois moins des patients qui ont continué à souffrir de DC que le groupe de contrôle. Conclusion : Dans la chirurgie de la main, une couverture analgésique périopératoire est essentielle pour réduire l’intensité de la DAPO, la fréquence de la DCPC et pour améliorer la qualité de vie des patients. Mots-clés : essai clinique, douleur chronique, chirurgie, main, analgésie préventive, plexus brachial. / Objectives: Demonstrate the superiority of Optimal Perioperative Analgesia compared to Usual Analgesic Treatment to reduce the intensity of Acute Postoperative Pain (APOP), the frequency of occurrence of Chronic Post Surgical Pain (CPSP) and improve patients’ quality of life. Methods: A double-blinded randomized clinical trial conducted in Notre-Dame Hospital on 57 patients who underwent a trapeziectomy. After locoregional analgesia via a catheter in the brachial plexus, the experimental group received an infusion of bupivacaine 0.5%, which started in the recovery room and continued for 72 h as an outpatient through an infusion pump. Meanwhile, the control group received a saline solution. Both groups took celecoxib during the same period. The evolution of pain profile, hand function and patients’ quality of life have been obtained using questionnaires and functional tests in the preoperative period and through months of follow-up. Results were analyzed using General Linear Model. A difference of 2 in the intensity of pain, measured by Visual Analogue Scale (VAS: 0-10), was considered statistically significant. Results: This method resulted in a significant decrease in the intensity of APOP and Chronic Pain (CP) compared to usual treatment. General activities, quality of sleep and patients’ concentration were better in the experimental group. Moreover, two times less patients continued to suffer from the CP than in the placebo group. Conclusion: In hand surgery, a perioperative analgesic coverage is necessary to reduce the APOP intensity, the CPSP frequency and to improve patients’ quality of life. Keywords: clinical trial, chronic pain, surgery, hand, preemptive analgesia, brachial plexus.

La prééclampsie est responsable du quart des mortalités maternelles et est la deuxième cause de décès maternels associés à la grossesse au Canada et dans le monde. L’identification d’une stratégie efficace pour la prévention de la prééclampsie est une priorité et un défi primordial dans les milieux de recherche en obstétrique. Le rôle des éléments nutritifs dans le développement de la prééclampsie a récemment reçu davantage d’attention. Plusieurs études cliniques et épidémiologiques ont été menées pour déterminer les facteurs de risque alimentaires potentiels et examiner les effets d’une supplémentation nutritive dans le développement de troubles hypertensifs de la grossesse. Pour déterminer les effets de suppléments antioxydants pris pendant la grossesse sur le risque d’hypertension gestationnelle (HG) et de prééclampsie, un essai multicentrique contrôlé à double insu a été mené au Canada et au Mexique (An International Trial of Antioxidants in the Prevention of Preeclampsia – INTAPP). Les femmes, stratifiées par risque, étaient assignées au traitement expérimental quotidien (1 gramme de vitamine C et 400 UI de vitamine E) ou au placebo. En raison des effets secondaires potentiels, le recrutement pour l’essai a été arrêté avant que l’échantillon complet ait été constitué. Au total, 2640 femmes éligibles ont accepté d’être recrutées, dont 2363 (89.5%) furent incluses dans les analyses finales. Nous n’avons retrouvé aucune évidence qu’une supplémentation prénatale de vitamines C et E réduisait le risque d’HG et de ses effets secondaires (RR 0,99; IC 95% 0,78-1,26), HG (RR 1,04; IC 95% 0,89-1,22) et prééclampsie (RR 1,04; IC 95% 0,75-1,44). Toutefois, une analyse secondaire a révélé que les vitamines C et E augmentaient le risque de « perte fœtale ou de décès périnatal » (une mesure non spécifiée au préalable) ainsi qu’une rupture prématurée des membranes avant terme. Nous avons mené une étude de cohorte prospective chez les femmes enceintes recrutées dans l’INTAPP afin d’évaluer les relations entre le régime alimentaire maternel en début et fin de grossesse et le risque de prééclampsie et d’HG. Un questionnaire de fréquence alimentaire validé était administré deux fois pendant la grossesse (12-18 semaines, 32-34 semaines). Les analyses furent faites séparément pour les 1537 Canadiennes et les 799 Mexicaines en raison de l’hétérogénéité des régimes alimentaires des deux pays. Parmi les canadiennes, après ajustement pour l’indice de masse corporelle (IMC) précédant la grossesse, le groupe de traitement, le niveau de risque (élevé versus faible) et les autres facteurs de base, nous avons constaté une association significative entre un faible apport alimentaire (quartile inférieur) de potassium (OR 1,79; IC 95% 1,03-3,11) et de zinc (OR 1,90; IC 95% 1,07-3,39) et un risque augmenté de prééclampsie. Toujours chez les Canadiennes, le quartile inférieur de consommation d’acides gras polyinsaturés était associé à un risque augmenté d’HG (OR 1,49; IC 95% 1,09-2,02). Aucun des nutriments analysés n’affectait les risques d’HG ou de prééclampsie chez les Mexicaines. Nous avons entrepris une étude cas-témoins à l’intérieur de la cohorte de l’INTAPP pour établir le lien entre la concentration sérique de vitamines antioxydantes et le risque de prééclampsie. Un total de 115 cas de prééclampsie et 229 témoins ont été inclus. Les concentrations de vitamine E ont été mesurées de façon longitudinale à 12-18 semaines (avant la prise de suppléments), à 24-26 semaines et à 32-34 semaines de grossesse en utilisant la chromatographie liquide de haute performance. Lorsqu’examinée en tant que variable continue et après ajustement multivarié, une concentration de base élevée de gamma-tocophérol était associée à un risque augmenté de prééclampsie (quartile supérieur vs quartile inférieur à 24-26 semaines : OR 2,99, IC 95% 1,13-7,89; à 32-34 semaines : OR 4,37, IC 95% 1,35-14,15). Nous n’avons pas trouvé de lien entre les concentrations de alpha-tocophérol et le risque de prééclampsie. En résumé, nous n’avons pas trouvé d’effets de la supplémentation en vitamines C et E sur le risque de prééclampsie dans l’INTAPP. Nous avons toutefois trouvé, dans la cohorte canadienne, qu’une faible prise de potassium et de zinc, tel qu’estimée par les questionnaires de fréquence alimentaire, était associée à un risque augmenté de prééclampsie. Aussi, une plus grande concentration sérique de gamma-tocophérol pendant la grossesse était associée à un risque augmenté de prééclampsie. / Preeclampsia (PE) accounts for about one-quarter of cases of maternal mortality, and ranks second among the causes of pregnancy-associated maternal deaths in Canada and worldwide. The identification of an effective strategy to prevent PE is a priority and fundamental challenge in obstetrics research. The role of nutritional factors in the etiology of PE has recently received increased attention. Many clinical and epidemiological studies have been conducted to investigate potential dietary risk factors for PE and to examine the effects of nutritional supplementation on the development of hypertensive disorders of pregnancy. To investigate the effects of prenatal antioxidant supplementation on the risk of gestational hypertension (GH) and PE, a double blind, multicenter trial (The International Trial of Antioxidants for the Prevention of Preeclampsia – the INTAPP trial) was conducted in Canada and in Mexico. Women were stratified by their risk status and assigned to daily experimental treatment (1 gram vitamin C and 400 IU vitamin E) or to placebo. Due to concerns about potential adverse effects, recruitment for the trial was stopped before the full sample had been achieved. A total of 2640 consenting eligible women had been recruited at that point with 2363 women (89.5%) included in the final analysis. We found no evidence that prenatal supplementation of vitamins C and E reduced the risk of GH and its adverse conditions (RR: 0.99, 95% CI 0.78-1.26), GH (RR 1.04, 95% CI 0.89-1.22), and PE (RR 1.04, 95% CI 0.75-1.44). However, in a secondary analysis, we found that vitamins C and E increased the risk of ‘fetal loss or perinatal death’ (a non-pre-specified outcome) as well as preterm premature rupture of membranes (PPROM). We conducted a prospective cohort study on pregnant women enrolled in the INTAPP trial to investigate the associations between maternal diet in early and late pregnancy and the risk of PE and GH. A validated food frequency questionnaire (FFQ) was administered twice during pregnancy (12-18 weeks, 32-34 weeks). Analyses were conducted separately for 1537 Canadian and 799 Mexican women as there were significant heterogeneities in various nutrient intakes between the two countries. Among Canadian women, after adjusting for pre-pregnancy body mass index (BMI), treatment group, risk stratum (high versus low) and other baseline risk factors, we found that the lowest quartiles of potassium (OR 1.79, 95% CI 1.03-3.11) and zinc (OR 1.90, 95% CI 1.07-3.39) intake were significantly associated with an increased risk of PE. Also in Canadian women, the lowest quartile of polyunsaturated fatty acids was associated with an increased risk of GH (OR 1.49, 95% CI 1.09-2.02). None of the nutrients analyzed were found to be associated with PE and GH risk among Mexican women. We further conducted a case control study ancillary to the INTAPP trial to assess the relationship between plasma concentration of antioxidant vitamins and the risk of PE. A total of 115 PE cases and 229 matched controls were included. Vitamin E concentrations were measured longitudinally at 12-18 weeks (prior to supplementation), 24-26 weeks, and 32-34 weeks of gestation using high-performance liquid chromatography (HPLC). When examined as a continuous variable, and after multivariate adjustment, elevated baseline gamma-tocopherol concentrations were associated with an increased risk of PE (OR 1.35, 95% CI 1.02-1.78). Analyses of repeated measurements indicated that elevated gamma-tocopherol levels were associated with an increased risk of PE (highest vs. lowest quartile at 24-26 weeks: OR 2.99, 95% CI 1.13-7.89; at 32-34 weeks: OR 4.37, 95% CI 1.35-14.15). We found no associations between alpha-tocopherol concentrations and the risk of PE. In summary, we found no effects of vitamins C and E supplementation on the risk of PE in the INTAPP trial. However, in the Canadian cohort we found that lower intakes of potassium and zinc as estimated by the FFQ were associated with an increased risk of PE. Moreover, higher plasma concentration of gamma-tocopherol during pregnancy was associated with an increased risk of PE.

Le Mali est devenu un milieu attractif pour les essais cliniques. Cependant, le cadre de réglementation pour leur surveillance y est très limité. Le pays manque de l’expertise, de l’infrastructure et des ressources nécessaires pour mettre en œuvre pleinement la régulation. Ceci représente un risque pour la sécurité des sujets de recherche et l’intégrité des résultats scientifiques. Il ne permet pas non plus de s’aligner sur les normes internationales en vigueur, telles que la déclaration d’Helsinki, les directives éthiques internationales du Conseil des organisations internationales des sciences médicales (CIOMS) ou les réglementations de pays industrialisés comme les États-Unis, le Canada ou l’Union Européenne. Pour améliorer la situation, la présente étude vise à comprendre les enjeux de la régulation des essais cliniques au Mali afin de suggérer des pistes de solutions et des recommandations. L’étude a été réalisée à l’aide de méthodes qualitatives, soit l’examen de documents officiels et des entrevues semi-dirigées avec les principaux acteurs impliqués dans les essais cliniques. La théorie néo-institutionnelle a servi de toile de fond à l’analyse des données. L’approche néo-institutionnelle consiste à expliquer l’influence de l’environnement sur les organisations. Selon cette approche, l’environnement s’assimile à des champs organisationnels incluant les connexions locales ou non, les liens horizontaux et verticaux, les influences culturelles et politiques ainsi que les échanges techniques. Les résultats présentés dans un premier article montrent l’existence de nombreux enjeux reflétant la carence du système de régulation au Mali. La coexistence de quatre scénarios d’approbation des essais cliniques illustre bien l’inconsistance des mécanismes. Tout comme l’absence d’inspection, l’inconsistance des mécanismes traduit également l’intervention limitée des pouvoirs publics dans la surveillance réglementaire. Ces enjeux résultent d’une double influence subie par les autorités réglementaires et les comités d’éthique. Ceux-ci sont, d’une part, influencés par l’environnement institutionnel sous pressions réglementaires, cognitives et normatives. D’autre part, les pouvoirs publics subissent l’influence des chercheurs qui opèrent comme des entrepreneurs institutionnels en occupant un rôle central dans le champ de la régulation. Dans un second article, l’étude propose une analyse détaillée des facteurs influençant la régulation des essais cliniques. Ces facteurs sont synthétisés en cinq groupes répartis entre deux sphères d’influence. L’analyse montre combien ces facteurs influencent négativement la régulation, notamment : 1) la structuration inachevée du champ de régulation due à un faible degré d’interactions, une absence de structure de coordination, d’informations mutuelles et de conscience dans la constitution des interdépendances; et 2) les positions relatives des acteurs impliqués dans la construction du champ de régulation se manifestant par une faible autorité des pouvoirs publics et l’ascendance des groupes de recherche. Enfin, dans un troisième article nous proposons quelques mécanismes qui, s’ils sont mis en œuvre, pourraient améliorer la régulation des essais cliniques au Mali. Ces mécanismes sont présentés, en référence au cadre théorique, sous trois types de vecteurs d’influence, notamment réglementaires, normatifs et cognitifs-culturels. En guise de conclusion, l’étude envoie un signal fort pour la nécessité d’une régulation appropriée des essais cliniques au Mali. Elle montre que la plupart des problèmes de fond en matière de régulation relèvent d’un besoin de restructuration du champ organisationnel et de renforcement de la position des pouvoirs publics. / Mali has become an attractive environment for clinical trials. However, the regulatory framework for oversight of these trials is very limited. The country lacks the expertise, infrastructure and resources to fully implement the regulation. This represents a risk to the safety of research participants and the integrity of scientific results. As such, regulation in Mali does not meet international standards such as the Helsinki Declaration or the International Ethical Guidelines of the Council for International Organizations of Medical Sciences (CIOMS), or regulations of industrialized countries like the United States, Canada, or the European Union. To help address this situation, this study examines issues in the regulation of clinical trials in Mali in order to suggest possible solutions and provide recommendations. The study was carried out using qualitative methods; we reviewed official documents and conducted interviews with key stakeholders involved in clinical trials. Neo-institutional theory served as the framework with which to analyse the data. The focus of the neo-institutional approach is to explain the influence of the institutional environment on organizations. According to this approach, the institutional environment is composed of organizational fields such as local and non-local connections, vertical and horizontal ties, cultural and political influences, and technical exchanges. The results presented in the first article show that there are many issues that reflect the weakness of the regulatory system in Mali. The coexistence of four scenarios for approving clinical trials illustrates the inconsistency of current mechanisms. As well as the absence of inspection, there is also limited intervention on the part of the government in regulatory oversight. These issues arise from a double influence on the regulatory authorities and ethics committees. First, they are influenced by an institutional environment that is subject to regulatory, cognitive and normative pressures. Second, researchers operate as institutional entrepreneurs by occupying a central role in the field of regulation, and so influence the oversight bodies. In a second article, our study provides a detailed analysis of the factors influencing the regulation of clinical trials, synthesized into five groups that are divided into two spheres of influence. The analysis shows how these factors negatively influence regulation, specifically: 1) there is an incomplete structuring of the regulatory field due to a low degree of interaction, a lack of coordination structure, mutual information and consciousness in the constitution of interdependencies, and 2) the relative positions of the actors involved in the construction of the regulatory field manifests in a weak authority of the government and the domination of research groups. Finally, in a third article we propose some mechanisms that, if implemented, could improve the regulation of clinical trials in Mali. These mechanisms are presented, with reference to the theoretical framework, as three channels of influence, namely regulatory, normative and cultural-cognitive. In conclusion, the study sends a strong signal for the need for appropriate regulation of clinical trials in Mali. It shows that the most fundamental problems in regulation result from a need for restructuring of the organizational field and a strengthening the position of government

Problématique : La majorité des études publiées sur la réhabilitation par mise en charge immédiate de deux implants non jumelés avec une prothèse totale mandibulaire de recouvrement n’ont rapporté que des mesures cliniques objectives et très peu ont évalué les mesures centrées sur le patient, et ce, avec des erreurs de mesure. Aucune étude n’a évalué les attentes des patients vis-à-vis d'un tel protocole. Objectifs : Évaluer les attentes, le niveau de satisfaction ainsi que la qualité de vie reliée à la santé bucco-dentaire des édentés complets suite à un protocole de mise en charge immédiate. Méthodologie : Cet essai clinique de phase 1 utilise un design pré-post afin d’évaluer les mesures centrées sur le patient. Dix-huit individus, complètement édentés et âgés en moyenne de 62,39 ± 7,65 ans, ont reçu une prothèse totale mandibulaire de recouvrement sur deux implants non jumelés suite à un protocole de mise en charge immédiate, conjointement à une prothèse totale conventionnelle maxillaire. Un instrument adapté pour mesurer leurs attentes à l’aide d’échelles visuelles analogues, le questionnaire « McGill Denture Satisfaction Instrument » ainsi que le questionnaire OHIP-20 ont été remis aux patients avant de procéder aux traitements (T0), ainsi qu’aux rendez-vous de suivi à 2 semaines (T1), 1 mois (T2) et 4 mois (T3). De plus, l’inventaire de personnalité révisé (NÉO PI-R) ainsi qu’un questionnaire sociodémographique ont été remplis par les participants. Les « change scores » ont été calculés puis des tests non paramétriques et des analyses de variances en mesures répétées suivies de comparaisons par paires ont été utilisés afin d’analyser les données recueillies. La taille d’effet a été estimée. Résultats : Les participants avaient différentes attentes par rapport à la mise en charge immédiate. Certains s’attendaient à un effet positif à court terme par rapport à leur apparence esthétique (83,3 %) et à leur vie sociale (55,7 %), alors que d’autres avaient des craintes envers leur confort (5,6 %), leur habileté à mastiquer (11,1 %) et à nettoyer leur prothèse inférieure (11,1 %). À 4 mois, le protocole de mise en charge immédiate avait rencontré la majorité des attentes des patients par rapport à l’esthétique (94.4 %), la mastication (83.3 %), la phonétique (61.1 %), le confort (94.4 %), l’hygiène (88.9 %) et leur vie sociale (88.9 %). Une amélioration statistiquement significative de la satisfaction en générale, du confort, de l’esthétique, de la stabilité de la prothèse inférieure et de l’habileté à mastiquer a été notée à 2 semaines (p<0,001). Également, les comparaisons par paires ont révélé une diminution statistiquement significative du score total de l’OHIP-20 (p < 0,001) de même que la majorité des domaines de l’OHIP (p < 0.01), sauf pour l’handicap social qui n’a diminué significativement qu’après 1 mois (p = 0.01). Ces changements (pour la satisfaction et la qualité de vie) sont restés stables au cours des suivis subséquents. Indépendamment des traits de personnalité et des variables sociodémographiques, le protocole immédiat a satisfait 94,4 % des participants et a amélioré leur qualité de vie avec une large magnitude d’effet (d = 1.9; p < 0.001). Bien que deux patients aient perdu des implants au cours du traitement, 100 % des participants étaient d’accord pour recommander cette procédure à leurs pairs. Conclusions: Le protocole de mise en charge immédiate semble satisfaire les patients quelles que soient leurs attentes. Le protocole MCI peut améliorer, à court terme, la qualité de vie des patients totalement édentés. Les résultats prometteurs de la phase 1 devraient être corroborés lors de la 2e phase de cette étude. / Statement of problem: Most published research on the immediate loading of a mandibular 2-implant overdenture has only reported on clinical outcomes. Few studies have evaluated patients centered-outcomes but with measurement errors. Consequently, there is a need to assess clinical and patient-reported outcomes in this regard. Objectives: To examine patients’ level of satisfaction, expectations and quality of life with regard to the implants’ immediate loading protocol in edentate individuals. Methods: This phase-I trial used a pre-post design to assess patient-centered outcomes in 18 edentate individuals (mean age 62.39 ± 7.65 years) who have received a 2-implant (unsplinted) mandibular overdenture through an immediate loading protocol. The McGill Denture Satisfaction Instrument, a VAS instrument assessing expectations and the OHIP-20 questionnaire were used to evaluate patients’ outcomes at baseline, 2 weeks, 1 and 4 months. Socio-demographic and personality trait data were obtained using the Revised NEO Personality Inventory and a self-administered questionnaire. Change scores were calculated and non-parametrical tests were used to analyse the data. Repeated measures ANOVAs and paired t-tests were also conducted, and effect size was estimated. Results: The participants had a wide range of expectations regarding the immediate loading protocol. Expectations included short-term positive impact on aesthetics (83.3 %) and social life (55.7 %). Other expectations included negative effects on comfort (5.6%), the ability to chew (11.1 %) and to clean their lower denture (11.1%). At 4 months, the immediate loading protocol had met most patients’ expectations regarding aesthetics (94.4%), the ability to chew (83.3%), ability to speak (61.1%), comfort (94.4%), the ability to clean their lower denture (88.9%) and their social life (88.9%). The statistical analysis showed an overall satisfaction increase with a median change score of 66 (range=7-98), 68 (range=7- 95), and 70 (range= 17- 99), at 2 weeks, 1 month and 4 months respectively. There was a statistically significant improvement in overall satisfaction, comfort, perceived aesthetics, stability of the overdenture, and ability to chew at 2 weeks (p < 0,001). Pairwise comparison (within-subjects comparisons) revealed significant decreases in total OHIP scores (P < 0.001), as well as fewer functional limitations, physical pain, psychological discomfort, physical disability, psychological disability, and handicap (P < 0.01) from baseline to 2 weeks, 1 month and 4 months follow-up. Social disability score decrease significantly only after 1 month follow-up (p = 0.01). These changes remained stable during subsequent follow-ups. The protocol satisfied 94.4% of the participants and improve their quality of life with an estimated effect size of 1.9 (p < 0.001), regardless of socio-demographic and personality profiles. There was 100% agreement among patients on recommending this procedure to their peers. Conclusions: Immediate loading of two unsplinted implants with a mandibular overdenture seemed to fulfill patients’ satisfaction regardless of their expectations and may improve oral health-related quality life of edentate individuals in short-term. Encouraging results from phase I should be confirmed and approved in Phase II clinical trials.

O objetivo desta tese foi identificar, analisar e sintetizar evidências científicas quanto à eficácia do Tratamento Convencional (TC) e do Tratamento Restaurador Atraumático (ART) em molares decíduos considerando os parâmetros de longevidade, custo, aceitabilidade e desfechos reportados pelo paciente. Este volume apresenta um compilado de uma revisão sistemática e dois ensaios clínicos randomizados orientados pelas recomendações PRISMA, CONSORT-PRO e CHEERS. Realizamos uma revisão sistemática, cuja pesquisa bibliográfica buscou por desfechos reportados pelo paciente (PROs) em relação a tratamentos restauradores na dentição decídua em estudos prospectivos indexados no PubMed, Scopus e OpenGrey até fevereiro de 2018. Meta-análise de Comparação de Tratamento Misto foi realizada considerando os resultados dos estudos revisados. Devido à incompatibilidade de dados, apenas dor, ansiedade e a qualidade de vida relacionada à saúde bucal (QVRSB) foram analisados estatisticamente. Adicionalmente, delineamos um ensaio clínico de não inferioridade randomizado por cluster cujo desfecho primário foi a longevidade do TC e do ART em cavidadades oclusais e oclusoproximais de molares decíduos após 24 meses de acompanhamento. Como desfechos secundários, foram avaliados a aceitabilidade, representada pelo desconforto auto relatado e cooperação dos participantes, e a custo-eficácia. Crianças entre 3 e 6 anos apresentando pelo menos uma cavidade oclusal ou oclusoproximal em molares decíduos foram randomizadas entre os grupos convencional (TC) com resina composta sob isolamento absoluto após anestesia local ou o ART. Em ambos os grupos foi realizada remoção parcial de tecido cariado. O estudo foi desenvolvido em um trailer odontológico localizado no interior de uma escola municipal de Barueri/SP. Imediatamente após cada sessão restauradora, foi mensurado o desconforto auto relatado pelo participante e o comportamento pelo operador através da Escala Facial de Wong-Baker e escala de 5 pontos, respectivamente. As restaurações oclusais e oclusoproximais foram avaliadas após 6, 12, 18 e 24 meses segundo o critério de Frencken et al. 1998 e de Roeleveld et al. 2006. Os custos profissional e do procedimento, subdividido em custos variável e do material de consumo, foram considerados para estimar o custo incremental dos tratamentos. Regressão de Poisson em análise de multinível, Regressão de Cox com fragilidade compartilhada e regressão de Bootstrap foram utilizadas para testar o desconforto e cooperação, a sobrevida e o custo entre os tratamentos e outras variáveis independentes. O nível de significância foi ajustado em 5%. Tratamentos restauradores que utilizam agentes quimicomecânicos ou apenas instrumentos manuais para remoção de tecido cariado, como o ART, resultaram em menores índices de ansiedade e menor tendência em provocar dor em crianças do que tratamentos que utilizam instrumentos rotatórios e/ou anestesia. A QVRSB não foi influenciada pelos tratamentos restauradores nem diferiu entre os grupos. Por outro lado, o TC e o ART apresentaram baixa taxa de desconforto e alto índice de cooperação sem diferença estatisticamente significante entre eles. Ambos os tratamentos apresentaram sobrevida semelhante nas cavidades oclusais após 24 meses de acompanhamento, porém o custo do ART foi menor, demonstrando ser a opção mais custo-eficaz. Em relação às restaurações oclusoproximais, apesar do desempenho do TC ser superior ao ART, ele apresentou maior custo. Pode-se concluir que ansiedade e dor estão diretamente relacionados com tratamentos restauradores mais invasivos. Por outro lado, o TC e o ART apresentaram desconforto, cooperação e custo-eficácia semelhantes no tratamento de molares decíduos. Palavras-chave: Restauração dentária permanente. Dente decíduo. Longevidade. Custos e análises de custo. Medidas de resultados relatados pelo paciente. Ensaio clínico. Revisão. Odontopediatria. / The aim of this thesis was to identify, analyze and synthesize scientific evidences regarding the efficacy of conventional treatment (CT) and Atraumatic Restorative Treatment (ART) in primary molars considering the parameters of longevity, cost, acceptability and patient reported outcomes. This volume presents a compilation of a systematic review and two randomized clinical trials guided by the PRISMA, CONSORT-PRO and CHEERS recommendations. We performed a systematic review whose literature search included outcomes reported by the pediatric patient (PROs) related to restorative treatments in the primary dentition in prospective studies indexed in PubMed, Scopus and OpenGrey until February 2018. Mixed Treatment Comparison analysis was performed considering the results of the reviewed studies. Due to data incompatibility, only pain, anxiety and oral health related to quality of life (OHRQoL) were analyzed statistically. Additionally, we designed a cluster randomized non-inferiority clinical trial whose primary outcome was the longevity of occlusal and occlusoproximal ART and TC restorations in primary molars after 24 months of follow-up. As secondary outcomes, acceptability, represented by self-reported discomfort and participant cooperation, and cost-efficacy were assessed. Children between 3 and 6 years old presenting at least one occlusal or occlusoproximal cavity in primary molars were randomized between the conventional group (TC) with composite resin under rubber dam isolation after local anesthesia or ART. Partial removal of carious tissue was performed in both groups. The study was carried out in a dental trailer located inside a municipal school in Barueri/SP. Immediately after each restorative session, self-reported discomfort and participant cooperation were measure through the Wong-Baker Facial Scale and a 5-point scale, respectively. The occlusal and occlusoproximal restorations were evaluated after 6, 12, 18 and 24 months according to the criteria of Frencken et al. 1998 and Roeleveld et al. 2006. The professional and procedural costs, subdivided into variable and material of consumption\' costs, were considered to estimate treatments\' incremental cost. Poisson regression in multilevel analysis, Cox regression with shared fragility and Bootstrap regression were used to test discomfort and cooperation, survival and cost between treatments and among others independent variables. The level of significance was set at 5%. Restorative treatments using chemomechanical agents or only manual instruments, such as ART, were related to lower anxiety rates and less tendency to provoke pain in children compared to treatments using rotary instruments and/or anesthesia. OHRQoL was not influenced by restorative treatments nor differed between groups. On the other hand, CT and ART presented low rate of discomfort and a high cooperation with no statistically significant difference between them. Both treatments presented similar survival rates in occlusal restorations after 24 months of follow-up, but the ART cost was lower, proving to be the most cost-effective option. Regarding occlusoproximal restorations, although CT performance was superior to ART, it presented a higher cost. It can be concluded that anxiety and pain are directly related to more invasive restorative treatments. Differently, CT and ART have similar discomfort, cooperation and cost-efficacy in the treatment of primary molars.

Introdução: Especula-se que a Oniomania ou Compras Compulsivas (CC) compartilhe características clínicas e substratos neurobiológicos com a dependência de substâncias psicoativas, assim como outros comportamentos denominados dependências comportamentais. Os estudos mais recentes para tratamento das dependências têm explorado o potencial clínico de fármacos capazes de bloquear o efeito reforçador dessas substâncias ou comportamentos através da modulação direta ou indireta da atividade dopaminérgica na via córtico-límbico-estriatal. Seguindo esta linha de raciocínio, o topiramato vem sendo investigado para o tratamento do transtorno do jogo, compulsão alimentar e dependência de álcool. Relatos preliminares sugerem potencial desta medicação no tratamento de pacientes com CC. Método: Nosso estudo é um ensaio clínico duplo cego, randomizado e controlado com placebo que visa a testar a eficácia do topiramato administrado oralmente no tratamento das CC ao longo de 12 semanas. Foram analisados 43 pacientes, alocados aleatoriamente no grupo experimental (que recebeu doses flexíveis de topiramato de 25 a 300 mg/dia) ou grupo controle (que recebeu dose correspondente de substância inativa). Ambos os grupos receberam intervenções psicoeducacionais em quatro sessões. Os comportamentos e a psicopatologia das CC, além de fenômenos associados, especificamente impulsividade, sintomas depressivos e adequação social foram avaliados como desfecho. Resultados: As escalas de avaliação não apresentaram significância quando analisadas em conjunto pela MANOVA. Todavia, na análise do desempenho isolado de cada variável incluída no modelo múltiplo, encontrou-se uma redução significativa do comportamento de comprar compulsivo e desejo de aquisição em favor do topiramato, quando comparado ao placebo. Entre as escalas de avaliação de fenômenos associados, houve uma melhora ao longo do tempo em ambos os grupos para as variáveis que medem impulsividade e depressão, com tamanhos de efeito elevados (H2 > 0,14). Os achados devem ser analisados com cautela, uma vez que nossa amostra foi pequena e portanto com baixo poder amostral. Conclusão: Analisados em conjunto, os dados não permitem concluir que o topiramato seja superior ao placebo no tratamento das CC. Porém, esta análise encoraja futuras investigações / Introduction: It is speculated that Compulsive Buying Disorder (CBD), similar to other behavior addictions, shares clinical and neurobiologic characteristics with substance use disorders. Recent research for treatment of addictions has explored the therapeutic potential of drugs capable of blocking the reinforcing properties of substances or behaviors through the direct or indirect modulation of the dopaminergic pathway in the cortico-limbic-striatal circuit. In line with this reasoning, topiramate has been investigated for the treatment of gambling disorder, binge eating and alcohol addiction. Preliminary case reports suggest that this drug can be beneficial for the treatment of CBD. Methods: We followed a randomized, double-blind, placebo controlled model to test the efficacy and safety of topiramate during a period of 12 weeks. We analyzed 43 patients randomly assigned to the experimental group (who received flexible doses of topiramate from 25 to 300mg/day) or control group (who received the correspondent dose of inactive substance). Both groups received psychoeducational intervention in 4 sessions. Results: The variables we used to evaluate the symptomatology of CBD showed no significant variations over time when analyzed together through MANOVA. However, among the scales used to evaluate associated phenomena, there was an improvement over time for the variables that measure impulsivity and depression, with high effect sizes (H2 > 0.14). In the analysis of the isolated performance of each variable included in the multiple model we found a superior and statistically significant response of the group topiramate for the CBFS and the subscore acquisition of SI-R. These findings should be analyzed with caution since our sample was small, with low power, and composed by an under-representative sample of individuals. Conclusion: These findings point to a possible utility of topiramate for the treatment of CBD, supporting further studies with larger and more representative samples of patients with CBD

Objetivo: Verificar a eficácia da associação do alongamento do tronco com exercícios de estabilização segmentar em pacientes com dor lombar crônica inespecífica (LCI). Métodos: Trinta e quatro indivíduos com diagnóstico de lombalgia crônica inespecífica de ambos os sexos, com idade entre 18 e 65 anos, foram randomizados em dois grupos: Grupo Alongamento Placebo + Estabilização Segmental (GAPES) e Grupo Alongamento + Estabilização Segmentar (GAES). Cada grupo realizou 12 sessões de tratamento de uma hora, duas vezes por semana. Os desfechos primários foram: intensidade da dor (Escala Numérica de Dor-END); avaliação qualitativa da dor (Questionário McGill-QMG); e incapacidade funcional (Questionário de Incapacidade de Rolland e Morris-QRM). Os desfechos secundários foram: percepção do efeito global (PEG); estado emocional (Inventário de Depressão de Beck-IDB e Escala Visual Analógica para Ansiedade-EVA-A); sinais e sintomas adversos; e satisfação do paciente (MedRisk). Cada sujeito foi avaliado no início e no fim do tratamento (seis semanas) e seguido três e seis meses após a intervenção. O nível de significância definido em alfa é igual a 0,05. Resultados: Não houve diferença significativa entre os dois grupos de tratamento na redução da intensidade e na qualidade da dor, na incapacidade funcional, na ansiedade e nos índices emocionais após o término do tratamento e durante o follow up. Conclusão: As duas propostas são efetivas no tratamento de LCI, com resultados estatisticamente significantes nos desfechos estudados. No entanto, a associação de exercícios de alongamento de tronco com os de estabilização segmentar não foi mais efetiva do que o uso isolado de estabilização segmentar lombar (ESL) / Objective: To verify the effectiveness of the association of trunk stretching with segmental stabilization exercises in patients with non-specific chronic low back pain (LCI) Methods: Thirty-four individuals with a diagnosis of non-specific chronic low back pain of both sexes, aged between 18 and 65 years. They were randomized into two groups: Group Stretching Placebo + Segmental Stabilization (GSPSS) and Group Stretching + Segmental Stabilization (GSSS), each group received 12 sessions of one hour, twice a week. The primary outcomes were pain intensity (Numerical Rating Scale-NRS); qualitative pain assessment (McGill Questionnaire); functional disability (Rolland and Morris Questionnaire-RMQ). The secondary outcomes were perception of the overall effect Global Effect; emotional state (Beck Depression Inventory-BDI and Analog Visual Scale for Anxiety-VAS-A); adverse signs and symptoms; and patient satisfaction (MedRisk). Each subject was assessed at the baseline and in the end of treatment (six weeks) and followed up three and six months post-intervention. The significance level set at Alpha = 0.05. Results: There was no significant difference between the two treatment groups in reducing intensity and quality of pain, functional disability, anxiety and emotional indexes after the end of the treatment and during follow up. Conclusion: The two treatment proposals are effective in the treatment of LCI, with statistically significant results in the outcomes studied, but the association of trunk elongation exercises with those of segmental stabilization was not more effective than the isolated use of ESL

CONTEXTO E OBJETIVO: O manejo do carcinoma hepatocelular (HCC) é desafiador devido a agressividade tumoral e cirrose associada. Faltam opções locais efetivas após falha à quimioembolização transarterial (TACE). Nosso objetivo foi testar através de estudo prospectivo fase II, a eficácia e segurança da Radioterapia Estereotáctica Corpórea (SBRT) em pacientes com HCC e resposta parcial ou contraindicação à TACE. MÉTODO: Pacientes com até 5 lesões de HCC restritas ao fígado realizaram SBRT na dose de 30 a 50 Gy em 5 frações. O desfecho primário foi sobrevida livre de progressão das lesões tratadas. Os desfechos secundários foram sobrevida livre de progressão hepática, sobrevida livre de progressão a distância, sobrevida global e toxicidade. Este estudo está registrado em clinicaltrials.gov sob o número NCT02221778. RESULTADO: De novembro de 2014 a junho de 2018, 19 pacientes receberam SBRT na dose mediana de 40 Gy (range 30 - 50 Gy). Todos tinham escore de Child Pugh A. A idade mediana foi de 67 anos (range 42-84 anos). A doença de base foi hepatite C em 42%, hepatite B em 26% e álcool em 26%. TACE prévia foi realizada em 84% dos pacientes, com mediana de duas TACEs (range 0-5). O número mediano de lesões foi dois (range 1-4), com tamanho mediano de 4 cm (1,5-10 cm). 32% dos pacientes tinham trombose tumoral; a AFP mediana pré-tratamento foi de 142,5 ng/ml (range 4,2 - 5 494 ng/ml). A sobrevida livre de progressão local em 1 ano foi de 80% (IC95%, 50% a 93%). A sobrevida livre de progressão hepática, sobrevida livre de progressão a distância e sobrevida global em 1 ano foram, respectivamente, de 52%, 82% e 84%. Não houve toxicidades clínicas grau 3 ou 4. Toxicidades laboratoriais até grau 3 ocorreram em 3 pacientes (16%). Resposta radiológica completa foi atingida em 53% dos pacientes, 42% tiveram resposta parcial. O tempo mediano para melhor resposta foi de 3,4 meses (range 2,4-12,6 meses). CONCLUSÃO: A SBRT é uma opção eficaz, segura e não invasiva em pacientes com HCC e resposta parcial ou contraindicação à quimioembolização / BACKGROUND AND PURPOUSE: Management of hepatocellular carcinoma (HCC) is challenging due to tumor aggressiveness and associated cirrhosis. There is paucity of effective local options after failure of transarterial chemoembolization (TACE). Our objective was to test in the setting of a phase II prospective study, the efficacy and safety of Stereotactic Body Radiation Therapy (SBRT) in patients with partial response or unsuitable for TACE. METHODS: Patients with HCC and up to five liver-only lesions received SBRT 30 to 50 Gy in 5 fractions. Primary endpoint was local progression-free survival. Secondary endpoints were liver progression-free survival, distant progression-free survival, overall survival and toxicity. This study is registered at clinicaltrials.gov NCT02221778. RESULTS: From Nov 2014 through Jun 2018, 19 patients received SBRT with a median dose of 40Gy (range 30 - 50 Gy). All patients were Child Pugh A. Median age was 67 years old (range 42-84y). Underlying liver disease was hepatitis C in 42% of patients, hepatitis B in 26% and alcohol-related in 26%. 84% received previous TACE, with a median of two TACEs (range 0-5). Patients had a median of two lesions (range 1-4), with median size of 4 cm (1.5-10 cm). 32% had tumor vascular thrombosis; median pretreatment AFP was 142.5 ng/ml (range 4.2 - 5,494 ng/ml). 1y local progression-free survival was 80% (95% CI, 50% to 93%). 1y liver progression-free survival, distant progression-free survival and overall survival were, respectively, 52%, 82% and 84%. No patient had clinical grade 3 or 4 toxicities. Laboratory toxicities up to grade 3 occurred in three patients (16%). Complete radiological response was seen in 53% of patients, 42% had partial response. Median time for best response was 3.4 months (range 2.4-12.6 months). CONCLUSION: SBRT is an effective, safe and noninvasive option in HCC patients with partial response or unsuitable for TACE

Aim: To examine the relationship between reported vigorous physical activity (VPA) and body mass index (BMI) in children (6–7 years) and adolescents (13–14 years). Methods: In the International Study of Asthma and Allergies in Childhood Phase Three, 75 895 children's parents and 199 502 adolescents answered questions relating to VPA, height and weight. The association between VPA and BMI was analysed using general linear models, adjusting for country gross national index. Results: Compared to children who undertook no VPA, those in the infrequent group (once or twice per week) and those in the frequent group (three or more times per week) had mean (95% CI) BMI values 0.07 kg/m 2 (0.03–0.11) and 0.09 kg/m 2 (0.03–0.15) greater, respectively (p = 0.001). Compared to adolescents reporting no VPA, those in the infrequent group had a BMI 0.19 kg/m 2 (0.15–0.23) greater while those in the frequent group had a BMI 0.01 kg/m 2 (−0.03–0.05) greater (p < 0.0001). Conclusion: Reported VPA is not associated with lower BMI among children and adolescents. Investigation of VPA and BMI may be best undertaken in conjunction with other variables in the energy expenditure equation. A focus on VPA alone may be an inefficient way to manage BMI. / Revisión por pares