Background Anxiety experienced by individuals visiting the dental office to receive treatment is prevalent in the population. The clinical manifestation of these anxieties is considerable; it is estimated that approximately between 14 and 30 million people in the United States do not seek routine dental care due to dental anxiety. Dentists and other scientists have explored many techniques and procedures in attempts to ameliorate these anxieties and improve patient care. Biofeedback is a process that involves measuring a person's specific bodily functions such as blood pressure, heart rate, skin temperature, muscle tension, or breathing rate, and conveying the information to the patient in real-time. This raises the patient's awareness and therefore the possibility of conscious control of those functions. Evidence has shown biofeedback to be a useful modality of treatment for numerous conditions associated with anxiety. Anxiety has been shown to up-regulate the sympathetic nervous system. When the sympathetic nervous system is up-regulated, the pain threshold is decreased, and physiologic parameters of anxiety are manifested in the patient. This physiological phenomenon is well understood and demonstrates that, with anxiety, the individual will have a decreased pain threshold (i.e., greater response to noxious or painful stimuli). The purpose of the current pilot study is to investigate the use of a novel biofeedback system (RESPeRATE™) to reduce patients' pre-operative general anxiety levels and subsequently the pain associated with dental injections. Methods Eighty-one subjects participated in this randomized controlled study. Forty subjects were in the experimental group and forty-one subjects were in the control group. All subjects were asked to fill out a pre-injection survey (Dental Injection Sensitivity Survey - DISS), measuring baseline anxiety levels. Subjects in the experimental group used a biofeedback technique, while subjects in the control group were not exposed to any biofeedback. All participants then received an inferior alveolar local anesthetic injection. Subjects in both groups were then given a post-injection survey (measuring anxiety levels), and filled out a Visual Analog Scale (VAS). The VAS was designed to measure the subjects' perception of pain of the injection, the overall injection experience, and anticipatory anxiety for future injections. Results The results of the study demonstrated that there was no significant difference between the treatment group and the control group with respect to any of the pre/post-operative anxiety measures as recorded by the DISS. This study did demonstrate that with the use of the RESPeRATE™ device there was a significant difference in the overall injection experience between the experimental group and the control group (p=0.013), as measured by the VAS. A trend towards improved responses for the experimental group was noted with respect to both level of discomfort and ratings of future nervousness; these results did not reach a statically significance of p<.05. Conclusions Future studies and power calculation will be more specific towards the RESPeRATE™ in a dental setting, and lead to more accurate approximations on the number of subjects needed to determine whether the difference was due to chance or due to the treatment modality. It appears that this novel pilot study was underpowered. It would also be feasible to apply the technology to other areas in dentistry where anxiety and sympathetic up-regulation are etiologic components. Areas of future studies may include temporomandibular joint dysfunction, orofacial pain, periodontal disease, and wound healing.