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Silver diamine fluoride and interproximal caries progression in the primary dentitionDePalo, Joseph January 2019 (has links)
No description available.
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The Effect of Silver Diamine Fluoride on Caries Lesion Remineralization as a Function of Lesion Baseline Mineral DistributionAlMady, Fahad January 2022 (has links)
Indiana University-Purdue University Indianapolis (IUPUI) / Purpose: The primary objective of this laboratory study was to investigate whether the ability of SDF to remineralize caries lesion is modulated by their baseline mineral distribution. The exploratory objective was to determine whether the staining caused by SDF is modulated by lesion mineral distribution.
Materials and methods: This in vitro study utilized bovine permanent enamel specimens. SDF was compared to the clinical reference standard, 5% sodium fluoride varnish (FV), and deionized water (DIW) was the negative control. By utilizing three lesion creation protocols (methylcellulose [MeC], hydroxyethylcellulose [HEC], Carbopol [C907]), artificial caries lesions with different mineral distributions (n=20 per subgroup) were created in the enamel specimens Interventions were applied and the lesions remineralized using artificial saliva. Changes in mineral loss, lesion depth, mineral density of the surface zone, and lesion mineral distribution were determined using transverse microradiography. Throughout the study, color of the lesion and changes thereof were measured using a spectrophotometer. Data were analyzed by using two-way ANOVA. Pair-wise comparisons were performed using Fisher’s Protected Least Significant Differences to control the overall significance level at 5%.
Results: For changes in mineral loss, DIW in MeC showed significantly greater change (more remineralization) than both SDF (p<0.01) and FV (p=0.01), which were not different from one another (p=0.13). There were no statistically significant differences between SDF and FV in the other lesions (C907 – p=0.18; HEC – p=0.56). For changes in lesion depth, there was no statistically significant interaction between study factors lesion protocol and treatments (p=0.23) as well as the individual factors lesion protocols (p=0.08) and treatments (p=0.82). For changes in surface zone mineral density, SDF showed significant change in mineral density compared to FV (p=0.02); however, SDF was not different from with DIW (p=0.25). For lesion mineral distribution, MeC exhibited the greater mineral loss in the lesion body and lowest mineral density at the surface zone. HEC lesions were the deepest but exhibited modest differences in mineral loss between the lesion body and the surface zone. C907 lesions were somewhat between MeC and HEC. SDF in MeC had the highest mineral gain in the surface zone, while DIW resulted in the highest mineral gain in the lesion body. SDF in HEC showed the highest mineral gain in the surface area compared to FV and DIW, with all treatments resulting in the largest mineral gain to a similar extent in the lesion body. In C907, SDF showed the most mineral gain in the lesion body compared to DIW and FV, while differences in the surface zone between treatments were less pronounced. For color changes post intervention, SDF showed more darkening in C907 and HEC lesions compared to MeC (p<0.01) and compared to FV and DIW. For post remineralization, SDF treated C907 lesions became significantly whiter (p<0.01) compared to SDF in MeC and HEC which continued to get darker.
Conclusion: SDF did exhibit different remineralization abilities and behaviors and the modulation was based on lesion baseline mineral distribution. Staining resulting from SDF treatment varied significantly based on lesion mineral distribution.
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Longitudinal In Vitro Effects of Silver Diamine Fluoride on Early Enamel Caries Lesions / Longitudinal Effects of SDF on Early Enamel Caries LesionsThompson Alcorn, Alice-Anne January 2020 (has links)
Indiana University-Purdue University Indianapolis (IUPUI) / Objective: This study aimed to evaluate surface microhardness changes in early, incipient, non-cavitated white-spot, enamel caries lesions treated with silver diamine fluoride (SDF) longitudinally. The utilization of silver nitrate and potassium fluoride test groups served as additional controls to assist in evaluating if the remineralization effects were due to the silver or fluoride component in SDF. Hypotheses: 1. SDF treatment will result in increased surface microhardness of early, incipient, non-cavitated white-spot, enamel caries lesions compared to all other tested interventions. 2. Specimen storage for 2-weeks in artificial saliva will result in greater surface rehardening in lesions treated with SDF compared to other tested interventions. Design: This laboratory study had 5 intervention groups (SDF, silver nitrate (AgNO3), potassium fluoride (KF), 5.0-percent sodium fluoride varnish (FV), deionized water (DI)) × 2-time intervals after intervention (immediate & delayed pH-cycling), resulting in 10 groups (n = 18). Early, incipient, non-cavitated white-spot, enamel caries lesions were created in bovine enamel and extent of demineralization was determined using Vickers surface microhardness (VHNlesion). Intervention treatments were applied. Half the specimens from each group underwent immediate 5-day pH-cycling and half were stored in an incubator with artificial saliva for two weeks before undergoing 5-day pH-cycling. After pH-cycling, lesion hardness was evaluated using VHNpost. Specimens were then exposed to a second demineralization challenge and lesion softening was evaluated using VHNsecdem. Surface rehardening was calculated: ΔVHN =VHNpost - VHNlesion. Surface softening was calculated: ΔVHNsecdem =VHNsecdem – VHNpost. Data was analyzed using two-way ANOVA. Results: Immediately cycled, SDF had significantly (p < .0001) greater remineralization than DI, AgNO3, and FV. All delayed cycling groups had significantly (p < .0001) greater remineralization than FV. Significantly greater remineralization was noted in delayed AgNO3 (p < .0001), DI (p = .0003), and FV (p = .0006) compared to immediately cycled. After the second demineralization challenge, FV had significantly less surface softening than AgNO3 (p = 0.0002), DI (p = 0.0003), KF (p = 0.0225), and SDF (p = 0.0388) intervention groups. No significant difference was found between the pH-cycle timings. Conclusion: Based on our findings, FV maybe better suitable than SDF to treat early, incipient, non-cavitated white-spot, enamel caries lesions. Longitudinally, SDF exhibited greater remineralization than both FV and DI groups, though not statistically significant. However, upon a second demineralization challenge, FV significantly outperformed SDF in preventing surface softening. / 2021-09-30
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A comparison of the antimicrobial efficacy of silver diamine fluoride and silver nitrate: an in vitro studyLuke, Nicholas L 01 January 2018 (has links)
A COMPARISON OF THE ANTIMICROBIAL EFFICACY OF SILVER DIAMINE FLUORIDE AND SILVER NITRATE: AN IN VITRO STUDY
By: Nicholas L Luke, D.D.S.
A thesis submitted in partial fulfillment of the requirements for the degree of Master of Science in Dentistry at Virginia Commonwealth University.
Virginia Commonwealth University, May 2018
Thesis Advisor: William O. Dahlke Jr., D.M.D.
Pediatric Dentistry, Department Chair
Purpose: To determine the antimicrobial efficacy of SDF and SN/NaF.
Methods: Three bacterial species were combined to create an in vitro biofilm. Treatment was completed with SN, SN/NaF, SDF, SDF½ or untreated (control).
Results: The untreated group demonstrated significantly higher growth than all other treatment groups across the study. On the BHI-plates (1-day), there were significant differences between all treatments except SDF and SDF½. On the BHI-plates (3-days), SN/NaF was not significantly different from SDF or SDF½. On the L-MRS-plates (1-day), both SN treatment groups yielded significantly higher growth than the SDF groups. On the L-MRS-plates (3-days), SN yielded significantly higher growth than SN/NaF, SDF, and SDF½.
Conclusion: SDF is more effective than SN/NaF, with the exception of BHI-plates (3-days) only and SN/NaF is more effective than SN on primarily S. mutans and L. acidophilus. There is evidence of a possible antimicrobial tolerance of oral bacteria to silver.
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A comparison of the antimicrobial efficacy of silver diamine fluoride and silver nitrate: an ex vivo studyAlNajjar, Reham M 01 January 2018 (has links)
A comparison of the antimicrobial efficacy of silver diamine fluoride and silver nitrate on various cariogenic bacteria: an ex vivo study By: Reham AlNajjar, D.D.S.
A thesis submitted in partial fulfillment of the requirements for the degree of Master of Science in Dentistry at Virginia Commonwealth University. Virginia Commonwealth University, 2019
Thesis Advisor: William Dahlke, D.M.D., Associate Professor and Chair of Pediatric Dentistry, School of Dentistry
Purpose: The use of silver-based antimicrobials is an emerging method for the treatment of dental caries. In this study, the authors compare the efficacy of the two most prominent silver- based therapeutics, silver diamine fluoride (SDF) and silver nitrate (AgNO3), on cariogenic and non-cariogenic multispecies biofilms. Currently there is a lack of studies comparing the efficacy of SDF to AgNO3.
Methods: Plaque samples from anterior and posterior tooth sites from children presenting both with early childhood caries and caries-free children were collected, pooled, and utilized to create four ex vivo biofilm systems in artificial saliva. SDF and AgNO3 were administered to these biofilms and bacterial survival was quantified and compared to untreated controls.
Results: Each of the four pooled sample types was applied to plates coated in artificial saliva + 1% sucrose. Both SDF and AgNO3 were very effective against plaque derived biofilms when compared to untreated biofilms (P0.05) in the potency of each compound.
Conclusions: SDF and AgNO3 significantly inhibit ex vivo cariogenic and non-cariogenic biofilms at similar levels.
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Diamino fluoreto de prata - uma nova proposta para o tratamento não operatório de lesões proximais em molares decíduos: estudo clínico randomizado / Silver diamine fluoride - a new proposal for the non-operative treatment for approximal caries lesions in primary molars: randomized clinical trialMattos-Silveira, Juliana 20 April 2016 (has links)
Este ensaio clínico randomizado, cego e controlado com placebo teve como objetivo principal avaliar a eficácia do diamino fluoreto de prata (DFP) a 30% no tratamento não operatório de lesões de cárie em superfícies proximais de molares decíduos e compará-la a eficácia do infiltrante resinoso e a do controle do biofilme interproximal pelo uso do fio dental. Além disso, também avaliou a custo-eficácia e o desconforto dos tratamentos e a satisfação dos participantes quanto ao tratamento recebido. Para isso, foram selecionadas 141 crianças entre 3 e 10 anos de idade, que apresentavam pelo menos uma superfície proximal com lesão de cárie clinicamente em esmalte. A alocação dos participantes foi aleatória, de acordo com o tratamento: DFP a 30%, infiltrante resinoso de cárie e orientação para o uso diário do fio dental (controle). Todos os participantes receberam o tratamento ativo para os quais foram alocados e também o placebo dos tratamentos realizados nos outros grupos. Os custos dos materiais utilizados nos tratamentos foram registrados. Ao final da consulta de tratamento, foi aplicada aos participantes a Escala Facial de Wong-Baker para avaliação do desconforto. Os responsáveis pelos participantes, que concluíram o seguimento da pesquisa, responderam a um questionário de satisfação sobre o tratamento recebido. As crianças foram examinadas após 1 mês para avaliação de higiene bucal e também de presença de biofilme nas superfícies tratadas. Após 6, 12 e 24 meses, foram realizados exames visual e tátil para verificar a progressão das lesões tratadas, além de exame radiográfico aos 12 e 24 meses. Para avaliar a eficácia dos tratamentos, consideraram-se como desfechos: (I) qualquer progressão clínica da lesão tratada e (II) progressão para cavidade em dentina. A progressão radiográfica foi utilizada como um desfecho secundário e para comparar com o padrão clínico de progressão das lesões. Análises de regressão foram realizadas para verificar se os grupos de tratamento influenciaram os desfechos testados após 12 e 24 meses de seguimento (análise por protocolo - Poisson multinível e análise de sobrevida). Valores pontuais de custo-eficácia dos tratamentos foram calculados e, para comparar a custo-eficácia da implementação do uso do DFP em relação às outras opções testadas foi utilizada a razão de custo-eficácia incremental. Análises de regressão de Poisson foram utilizadas para verificar a associação entre o desconforto e variáveis explicativas. A satisfação dos participantes e seus responsáveis foi explorada descritivamente. Um total de 316 superfícies proximais foram incluídas, sendo a maioria classificada como escore 2 do ICDAS (Sistema Internacional de Detecção e Avaliação de Cárie) associadas à ausência de imagem radiográfica (46,8%). As perdas de seguimento foram de 15% e 24% aos 12 e 24 meses, respectivamente. Não houve associação entre o grupo de tratamento e a progressão das lesões aos 12 e 24 meses, tanta pela análise por protocolo como pela análise de sobrevida. A taxa de progressão clínica das lesões para cavidade em dentina foi de 2,5% aos 12 meses e de 5,6% aos 24 meses. As lesões que não apresentavam imagem radiográfica inicial não progrediram para o 1/3 médio de dentina ou mais. A condição clínica inicial das lesões foi associada à progressão das lesões em todas as análises. Já o risco de cárie foi associado à progressão das lesões aos 24 meses e também na análise de sobrevida. O tratamento com infiltrante resinoso apresentou o custo mais elevado, fazendo com que o tratamento com DFP apresentasse melhor relação custo-eficácia do que este primeiro. Os participantes tratados com o DFP e os que receberam orientação para o uso do fio dental relataram menor desconforto do que os tratados com o infiltrante resinoso. Os responsáveis se mostraram satisfeitos com o tratamento recebido, independentemente do grupo ao qual foram alocados. Conclui-se que o tratamento com DFP é tão eficaz quanto o infiltrante resinoso e a orientação para o uso do fio dental no controle das lesões iniciais em proximal de molares decíduos. No entanto, causa menor desconforto e apresenta custo-eficácia superior ao infiltrante resinoso, devendo ser preferível para superfícies proximais de molares decíduos, em situações nas quais o tratamento dessas lesões possa ser necessário, como por exemplo, pacientes com experiência de cárie. / This randomized, blinded and placebo-controlled clinical trial aimed to evaluate the efficacy of 30% silver diamine fluoride (SDF) as a non-operative treatment of the approximal surfaces of primary molars and to compare it with the efficacy of resin infiltration and the mechanical control of the interproximal biofilm by flossing. We also evaluated the cost-efficacy and the discomfort of the treatments as well as the parent\'s satisfaction regarding treatments. One hundred forty-one, 3-to-10-year-old, children were included. They must present at least one caries lesion clinically into enamel sited on an approximal surface of primary molar. Participants were randomly allocated to the following groups according to active treatment to be received: 30% SDF, caries resin infiltration, flossing orientation (control). All participants received the active treatment, in which they were allocated and they also received the placebo treatment corresponding to the other groups. Costs of materials used in the treatment were registered. In the end of treatment session, the Wong-Baker faces scale was applied to evaluate participants\' reported discomfort. Children were examined after 1 month to evaluation of the oral hygiene and the presence of the biofilm on the treated surfaces. After 6, 12 and 24 months, visual and tactile examinations were performed to verify the lesions progression. Radiography was taken at 12- and 24-month follow-ups. To evaluate the efficacy of non-operative treatments, two outcomes were considered: (I) any clinical progression and (II) progression to cavity into dentine. The radiographic progression was used as a secondary outcome and to evaluate with clinical standard of lesions progression. Regression analyses were used to verify if the treatment influenced on these outcomes after 12 and 24 months (per-protocol analyses - multilevel Poisson and survival analysis). Cost-efficacy ratios were calculated for the treatments. To compare the cost-efficacy of implementing the use of DFP versus other options tested, the incremental cost-efficacy ratio was used. Poisson regression analyses were used to verify the association between discomfort and explanatory variables. The parents\' satisfaction about the treatments were explored descriptively. A total of 316 approximal surfaces were included. The majority of them were classified as ICDAS (International Caries Detection and Assessment System) score 2 associated with absence of radiographic image. The dropout in the study was 15% and 24% at 12-month and 24-month follow-up, respectively. There was no association between treatment groups and lesions progression at 12 and 24 months, both for the per-protocol analysis and by survival analysis. The rate of clinical lesions progression to cavity into dentine was 2.5% at 12 months and 5.6% at 24 months. Lesions without initial radiographic image did not progress into the middle of the dentine or more. Baseline clinical condition of caries lesions was associated with lesions progression in all analyses. The caries risk was also associated to caries progression in 24-month analyses and in the survival analyses. The treatment with resin infiltration was costlier. Consequently, the treatment with SDF was more cost-effective than resin infiltration. The participants allocated to SDF and control groups reported less discomfort than those who was allocated to the resin infitrant group. The parents were satisfied with the treatment received during the study, independently of the group to which their children had been allocated. It is possible to conclude that the SDF is as efficacious as the resin infiltration and flossing orientation to control initial lesions in the approximal surfaces of primary molars. However, SDF causes less discomfort and presents superior cost-efficacy relationship than resin infiltration and could be preferable to treat approximal caries in primary molars in those situations in which the treatment could be necessary, for example, depending on patients\' caries experience.
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Diamino fluoreto de prata - uma nova proposta para o tratamento não operatório de lesões proximais em molares decíduos: estudo clínico randomizado / Silver diamine fluoride - a new proposal for the non-operative treatment for approximal caries lesions in primary molars: randomized clinical trialJuliana Mattos-Silveira 20 April 2016 (has links)
Este ensaio clínico randomizado, cego e controlado com placebo teve como objetivo principal avaliar a eficácia do diamino fluoreto de prata (DFP) a 30% no tratamento não operatório de lesões de cárie em superfícies proximais de molares decíduos e compará-la a eficácia do infiltrante resinoso e a do controle do biofilme interproximal pelo uso do fio dental. Além disso, também avaliou a custo-eficácia e o desconforto dos tratamentos e a satisfação dos participantes quanto ao tratamento recebido. Para isso, foram selecionadas 141 crianças entre 3 e 10 anos de idade, que apresentavam pelo menos uma superfície proximal com lesão de cárie clinicamente em esmalte. A alocação dos participantes foi aleatória, de acordo com o tratamento: DFP a 30%, infiltrante resinoso de cárie e orientação para o uso diário do fio dental (controle). Todos os participantes receberam o tratamento ativo para os quais foram alocados e também o placebo dos tratamentos realizados nos outros grupos. Os custos dos materiais utilizados nos tratamentos foram registrados. Ao final da consulta de tratamento, foi aplicada aos participantes a Escala Facial de Wong-Baker para avaliação do desconforto. Os responsáveis pelos participantes, que concluíram o seguimento da pesquisa, responderam a um questionário de satisfação sobre o tratamento recebido. As crianças foram examinadas após 1 mês para avaliação de higiene bucal e também de presença de biofilme nas superfícies tratadas. Após 6, 12 e 24 meses, foram realizados exames visual e tátil para verificar a progressão das lesões tratadas, além de exame radiográfico aos 12 e 24 meses. Para avaliar a eficácia dos tratamentos, consideraram-se como desfechos: (I) qualquer progressão clínica da lesão tratada e (II) progressão para cavidade em dentina. A progressão radiográfica foi utilizada como um desfecho secundário e para comparar com o padrão clínico de progressão das lesões. Análises de regressão foram realizadas para verificar se os grupos de tratamento influenciaram os desfechos testados após 12 e 24 meses de seguimento (análise por protocolo - Poisson multinível e análise de sobrevida). Valores pontuais de custo-eficácia dos tratamentos foram calculados e, para comparar a custo-eficácia da implementação do uso do DFP em relação às outras opções testadas foi utilizada a razão de custo-eficácia incremental. Análises de regressão de Poisson foram utilizadas para verificar a associação entre o desconforto e variáveis explicativas. A satisfação dos participantes e seus responsáveis foi explorada descritivamente. Um total de 316 superfícies proximais foram incluídas, sendo a maioria classificada como escore 2 do ICDAS (Sistema Internacional de Detecção e Avaliação de Cárie) associadas à ausência de imagem radiográfica (46,8%). As perdas de seguimento foram de 15% e 24% aos 12 e 24 meses, respectivamente. Não houve associação entre o grupo de tratamento e a progressão das lesões aos 12 e 24 meses, tanta pela análise por protocolo como pela análise de sobrevida. A taxa de progressão clínica das lesões para cavidade em dentina foi de 2,5% aos 12 meses e de 5,6% aos 24 meses. As lesões que não apresentavam imagem radiográfica inicial não progrediram para o 1/3 médio de dentina ou mais. A condição clínica inicial das lesões foi associada à progressão das lesões em todas as análises. Já o risco de cárie foi associado à progressão das lesões aos 24 meses e também na análise de sobrevida. O tratamento com infiltrante resinoso apresentou o custo mais elevado, fazendo com que o tratamento com DFP apresentasse melhor relação custo-eficácia do que este primeiro. Os participantes tratados com o DFP e os que receberam orientação para o uso do fio dental relataram menor desconforto do que os tratados com o infiltrante resinoso. Os responsáveis se mostraram satisfeitos com o tratamento recebido, independentemente do grupo ao qual foram alocados. Conclui-se que o tratamento com DFP é tão eficaz quanto o infiltrante resinoso e a orientação para o uso do fio dental no controle das lesões iniciais em proximal de molares decíduos. No entanto, causa menor desconforto e apresenta custo-eficácia superior ao infiltrante resinoso, devendo ser preferível para superfícies proximais de molares decíduos, em situações nas quais o tratamento dessas lesões possa ser necessário, como por exemplo, pacientes com experiência de cárie. / This randomized, blinded and placebo-controlled clinical trial aimed to evaluate the efficacy of 30% silver diamine fluoride (SDF) as a non-operative treatment of the approximal surfaces of primary molars and to compare it with the efficacy of resin infiltration and the mechanical control of the interproximal biofilm by flossing. We also evaluated the cost-efficacy and the discomfort of the treatments as well as the parent\'s satisfaction regarding treatments. One hundred forty-one, 3-to-10-year-old, children were included. They must present at least one caries lesion clinically into enamel sited on an approximal surface of primary molar. Participants were randomly allocated to the following groups according to active treatment to be received: 30% SDF, caries resin infiltration, flossing orientation (control). All participants received the active treatment, in which they were allocated and they also received the placebo treatment corresponding to the other groups. Costs of materials used in the treatment were registered. In the end of treatment session, the Wong-Baker faces scale was applied to evaluate participants\' reported discomfort. Children were examined after 1 month to evaluation of the oral hygiene and the presence of the biofilm on the treated surfaces. After 6, 12 and 24 months, visual and tactile examinations were performed to verify the lesions progression. Radiography was taken at 12- and 24-month follow-ups. To evaluate the efficacy of non-operative treatments, two outcomes were considered: (I) any clinical progression and (II) progression to cavity into dentine. The radiographic progression was used as a secondary outcome and to evaluate with clinical standard of lesions progression. Regression analyses were used to verify if the treatment influenced on these outcomes after 12 and 24 months (per-protocol analyses - multilevel Poisson and survival analysis). Cost-efficacy ratios were calculated for the treatments. To compare the cost-efficacy of implementing the use of DFP versus other options tested, the incremental cost-efficacy ratio was used. Poisson regression analyses were used to verify the association between discomfort and explanatory variables. The parents\' satisfaction about the treatments were explored descriptively. A total of 316 approximal surfaces were included. The majority of them were classified as ICDAS (International Caries Detection and Assessment System) score 2 associated with absence of radiographic image. The dropout in the study was 15% and 24% at 12-month and 24-month follow-up, respectively. There was no association between treatment groups and lesions progression at 12 and 24 months, both for the per-protocol analysis and by survival analysis. The rate of clinical lesions progression to cavity into dentine was 2.5% at 12 months and 5.6% at 24 months. Lesions without initial radiographic image did not progress into the middle of the dentine or more. Baseline clinical condition of caries lesions was associated with lesions progression in all analyses. The caries risk was also associated to caries progression in 24-month analyses and in the survival analyses. The treatment with resin infiltration was costlier. Consequently, the treatment with SDF was more cost-effective than resin infiltration. The participants allocated to SDF and control groups reported less discomfort than those who was allocated to the resin infitrant group. The parents were satisfied with the treatment received during the study, independently of the group to which their children had been allocated. It is possible to conclude that the SDF is as efficacious as the resin infiltration and flossing orientation to control initial lesions in the approximal surfaces of primary molars. However, SDF causes less discomfort and presents superior cost-efficacy relationship than resin infiltration and could be preferable to treat approximal caries in primary molars in those situations in which the treatment could be necessary, for example, depending on patients\' caries experience.
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Silver Diamine Fluoride and Oral Health-Related Quality of LifeJavdan, Nazafarin 01 January 2017 (has links)
Purpose: The purpose of this study was to study the association between Silver Diamine Fluoride (SDF) and Oral Health-Related Quality of Life as assessed by “The Early Childhood Oral Health Impact Scale” questionnaire. Methods: Parents of healthy children (ASA I and II) ages 1-5 with early childhood caries with reversible pulpitis who had application of SDF filled out a questionnaire at baseline and again after one month. The questionnaire was designed to evaluate the child’s behavior, physical abilities, pain, temperament, and how well the child gets along with others. Results: Wilcoxon Signed Rank Test was used to determine if responses to various ECOHIS items and the total scores were different between the two time points. Conclusion: Children with dental caries who had application of SDF reported less dental pain, less eating problems, higher quality of sleep and overall higher quality of life at one-month follow up compared with the baseline.
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