27 Clinical Trials for Various Conditions
This study will compare the post sedation events from three different multi-drug oral sedation regimens in order to help pediatric dentists determine the best course of action for their patients and prepare parents appropriately and caution them about the expected effects. Patients will be evaluated for adverse effects within two time periods at 8 and 24 hours post oral sedation procedure using surveys.
The purpose of this study is to determine if passive music listening decreases anxiety in patients undergoing dental procedures and if the effects of music therapy are influenced by gender, age, and amount or type of dental treatment needed.
Dental Fear and Anxiety is an emotional experiences affecting many children and adolescents which can lead to behavioral problems in the dental setting. The purpose of the proposed study is to investigate the effect of virtual reality on anxiety, behavior, and pain in children undergoing restorative dental procedures. Children enrolled in the study will include patients ages 6-18 who are healthy and require two or more dental sealants (at least one sealant per side). The participants in the study will serve as their own control using a split-mouth cross-over randomized control clinical trial design and will be randomly assigned to receive virtual reality or traditional behavior guidance techniques first during dental sealant placement. The objectives of this study are to explore the associations between the use of virtual reality distraction during dental sealant placement with Frankl score, FLACC scale, and anxiety based on the change in heart rate, and pain based on self-reported FPS-R when compared with to the control group. The crossover design will be assessed by a linear mixed model with patient treated as a random effect. This model will include treatment, visit, treatment by visit interaction term as well as a treatment sequence variable. Prior to analysis, the primary outcome measures will be assessed for normality using a Shapiro-Wilk statistic as well as quantile-quantile (QQ) plots. Should the data deviate sharply from a normal distribution, normalizing transformations will be sought and applied to the data.
The purpose of this study is to determine whether pre-visit positive imagery has an impact in decreasing dental anxiety and fear in pediatric patients as well as increasing patient cooperation during treatment visits. Patients needing at least 1 composite filling with nitrous and local anesthetic will receive a picture book if they are selected in the experimental group, and no picture book if they are in the control group. Patients will be asked to be fill out a pre-operative survey and post-operative survey asking how they feel about treatment. Parents will also be asked to fill out a post-operative survey.
The goal of this study is to evaluate non-drug approaches to reducing dental anxiety prior to non-surgical root canal treatment. This will be done by comparing two relaxation methods which will be performed immediately prior to scheduled, clinical non-surgical root canal treatment. Measures of anxiety will be evaluated prior to, and after, the relaxation intervention, as well as after the non-surgical root canal treatment is completed. Participation in the study is completed in a single study visit.
The overall objective of the activities described in this protocol is to examine the efficacy of the Internet-based intervention in the reduction of dental anxiety in patients seeking dental treatment. This study has 2 primary objectives and 2 secondary objectives: Primary Objective 1-Therapy Aides: To compare the efficacy of the intervention as administered by personnel with training and experience in cognitive behavioral therapy (CBT) to the efficacy of the intervention as administered by dental staff who have undergone a brief but specific training in the administration of the intervention. Primary Objective 2-Intervention Efficacy: To compare the efficacy of the intervention, administered by either type of therapy aide (CBT personnel or dental staff), to an active control condition. Secondary Objective 1-Tests of Moderators: To examine whether baseline levels of distress tolerance and pain sensitivity moderate the efficacy of the dental anxiety intervention, regardless of therapy aide, in comparison to an active control condition. Secondary Objective 2-Other Intervention Effects: To explore effects of the intervention beyond primary efficacy, including attendance at recall visits in the 12 months after the intervention; pain intensity; avoidance due to fear of dental procedures; and client satisfaction.
Exposure therapy, including its self-directed forms, is effective for treatment of specific phobias. Nevertheless, there are issues with patient adherence in the use of exposure therapy, including its self-directed formats. Technological advancements, as with smartphones, may improve adherence to self-directed exposure therapy, perhaps due to exposure stimuli being more readily accessible. Thus, there is a need to examine how presenting phobic material on a smartphone might promote increased adherence in conducting self-directed exposure. Additionally, exposure can incorporate phobic material from different perspectives (i.e., first-person or third-person), which is one factor that may impact treatment effectiveness. Participants will be randomly assigned to a treatment or control condition, and complete a pre-assessment and then a post-assessment two weeks later. The assessment consists of a multimodal approach (e.g., self-report, physiological response, and overt behavior). Participants in the treatment condition will be instructed to watch a standard exposure video of a dental examination and prophylaxis three times daily for two weeks. One week of videos was shown in a first-person perspective and the same video will be shown in a third-person perspective for one week. The study can demonstrate the potential utility of smartphone-based self-directed exposure therapy for specific phobia.
Children with intellectual/developmental disabilities (ID/DD) will experience less dental anxiety and cooperate better in a Sensory Adapted Dental Environment (modified visual, sensory, and somatosensory stimuli in a regular dental setting) than in a regular dental environment (RDE).
Pediatric patients are susceptible to show signs of fear. One of the scenarios that have always been a source of fear is undergoing a dental procedure. Fear of undergoing dental procedure has been addressed as "dental fear", which can lead to avoidance of receiving dental care and may result to a decline in proper oral hygiene. Fear stimulates multiple cerebral responses and can be often related to an increased stress level. Stress level fluctuations during dental procedures can be examined by blood and salivary biomarkers. Given accessibility and minimal invasiveness, the collection of saliva samples constitutes an easy and cost-effective diagnostic method to investigate a variety of oral and systemic conditions. Cortisol and alpha amylase are present within the saliva and their levels are supposedly influenced by stress. In contrast, salivary IgA is not known to be influenced by stress level and can be used in comparison as a non-stress salivary biomarker. Fear of dental appointments is a well-known cause of stress and activation of the sympathetic nervous system in adolescents undergoing dental procedure. However, the examination of stress and stress-related factors in young individuals attending their first dental appointment compared to young individuals who present for an orthodontic application is largely understudies. Therefore, the aims of the study are: 1) to measure stress salivary biomarkers in pediatric patients before undergoing dental and/or orthodontic procedures; 2) assess whether subjective stress to dental treatment (as measured by dental anxiety, stress, and dental fear) is associated with objective stress measurements (as measured by collection of stress salivary biomarkers).
The purpose of this study is to assess the effectiveness of nitrous oxide/oxygen administration in reducing the discomfort of intranasal midazolam administration for moderate sedation for dental procedures.
The purpose of this research study is to evaluate the effectiveness of virtual-reality audio-visual distraction goggles on pain and behavior scores in a population of 8-12 year old dental patients receiving routine dental care in an outpatient clinical setting.
This study will evaluate the perceptions of the effects of two anxiolytic medications commonly used during dental treatment in patients weighing 40 kilograms or more.
Objectives of this Phase I pilot trial are to provide data towards assessing and facilitating feasibility of a larger scale Phase II trial in which the effects of a calmative Comfort Talk® app can be unequivocally evaluated. Towards this goal we will pursue following outcome parameters for Phase I: Feasibility/acceptability assessment: Primary outcome parameter: • ability to obtain complete on-site data sets from at least 90% of patients enrolled (with at least 40% from patients in the app group and at least 40% from patients in the control group). Secondary outcome parameters: * ability to enroll 60 patients by day 150 after initiation of recruitment in the clinic (=day 1) * obtain 38 packages of filled out diary cards (at least 16 from patients in the app group and at least 16 from patients in the control group) * 90% of patients in app group listen to app ≥5 min Phase II preparation primary outcome parameter • anxiety at the end of the waiting room time Secondary outcome parameters * pain the end of the waiting room time * anxiety during treatment * pain during treatment * anxiety during 1 week after treatment * pain during 1 week after treatment * use of units of sedatives and analgesics during 1 week after treatment (assessed by prescription at end of the visit) * patient satisfaction
Dental and health anxiety are common and potentially distressing problems, for both patients and health care providers. Anxiety has been identified as a barrier to regular dental visits and as an important target for enhancement of oral health-related quality of life. possible groups, (1) high dental anxiety and (2) low dental anxiety. The study aimed to develop and evaluate a computerized cognitive-behavioral therapy dental anxiety intervention (C-CBT) that could be easily implemented in dental healthcare settings. A cognitive-behavioral protocol based on psychoeducation, exposure to feared dental procedures, and cognitive restructuring was developed. A randomized controlled trial was conducted (N=151) to test its efficacy. Consenting adult dental patients who met inclusion (e.g., high dental anxiety) and exclusion criteria were randomized to one of two groups, (1) immediate treatment (IT) (n=74) or (2) a waitlist control (WL) (n=77).
An increase in the utilization of anesthesia and sedation medications by non-anesthesiologists, including dentists, has grown dramatically. This has been prompted, in part, by the need for pharmacological tools to address high levels of fear and anxiety about dental care among the US population and the evidence of oral health disparities among those who are fearful . Given the prevalence of dental fear in the general population and in the various populations with the greatest burden of oral diseases, effective sedation techniques are needed that are safe and effective in the hands of general dentists that make up the "front line" in the efforts to reduce oral health disparities. This study is to determine whether, when compared to a saline placebo, a single intraoral submucosal administration of the benzodiazepine antagonist flumazenil (0.2 mg) is capable of attenuating in 10 minutes or less the central nervous system (CNS) depression produced by a paradigm of stacked sublingual dosing of triazolam (3 doses of 0.25 mg over 90 minutes).
This is a randomized study in which two groups will be used to compare the effectiveness of a computerized psychological therapy compared to an information only control group (pamphlet) for reducing fear of dental injections.
The goal of this clinical trial is to assess whether the presence of a certified therapy dog during dental procedures that require an injection reduces anxiety and improves behavior in pediatric dental patients. The main questions it aims to answer are: * Does the presence of a certified therapy dog during dental procedure requiring an injection reduce anxiety and improve behavior in pediatric dental patients? * How do the parents of pediatric dental patients who participate in the study view the use of a certified therapy dog in their child's treatment? * Does the presence of a certified therapy dog result in different concentrations of microbes in the treatment room? All participants will receive standard of care. Researchers will compare the group with a therapy dog present to a group who does not have a therapy dog present to see if heart rate, oxygen saturation, percentage of nitrous oxide administered, and Frankl scores differ between the groups.
The goal of this study is to determine whether intravenous sedation would contribute to the stabilization of hemodynamics in adult patients during periodontal/implant surgery compared to receiving local anesthesia during periodontal/implant surgery
The purpose of this pilot study is to investigate the efficacy of medical play in the dental setting to improve the behaviors and cooperation of neurotypical patients during dental visits. The specific aims of the study are as follows: 1. To evaluate differences in behaviors and cooperation levels of subjects utilizing medical play before a routine dental exam visit in comparison to those undergoing a routine dental exam visit without use of medical play. 2. To evaluate whether subjects who have a dental exam visit, with or without use of medical play, show improved behaviors and improved completion of components of the dental exam compared to their previous routine dental visit. 3. To evaluate provider perceptions of the behavior and cooperation of children using medical play before dental exam visits compared to dental exam visits without medical play. 4. To evaluate caregiver perceptions of the behavior and cooperation of children using medical play before dental exam visits compared to dental exam visits without medical play. 5. To evaluate patient perceptions of the dental exam, visit when medical play is used in comparison to dental exam visits without medical play. The hypotheses are as follows: 1. Subjects will have increased positive behaviors and improved cooperation during dental exam visits when medical play is utilized beforehand. 2. Providers will report improved behavior and cooperation from patients when medical play is utilized beforehand. 3. Parents will report improved behavior and cooperation from their children and report greater satisfaction with the dental visit when medical play is utilized beforehand. 4. Patients will report experiencing less anxiety, via the Modified Child Dental Anxiety Scale - Faces Version (MCDAS-f) after appointments in which medical play is utilized.
This study is a randomized clinical trial investigating the effectiveness of a Sensory Adapted Dental Environment (SADE) alone and together with a video-based modeling (VBM) component (VBM-SADE), compared to a regular dental environment (RDE) and/or VBM alone, to reduce anxiety, distress behavior, pain, and sensory discomfort during a dental cleaning in children with and without dental fear and anxiety.
The goal of this clinical trial is to determine the effects of virtual reality relaxation on dental anxiety levels of adolescents and adults during an orthodontic bonding procedure. The specific aim is to compare changes in the anxiety levels based on 1) psychological outcomes and 2) physiological outcomes between patients who experienced (virtual reality relaxation) VRR intervention during the orthodontic bonding procedure and those in the control group who did not receive the intervention After provding written consent, subjects will be randomized to either the virtual reality device usage during their bonding procedure or no virtual reality device. They will have vital signs taken/anxiety level measured and answer a questionnaire before and after the device/no device usage (30 minutes).
This clinical trial examines the efficacy of a Sensory-Adapted Dental Environment (SADE) in reducing anxiety and improving behavioral outcomes in children with sensory processing disorders during routine dental visits. By modifying the dental setting to accommodate sensory sensitivities-such as using dim lighting, noise-canceling headphones, and non-threatening dental tools-the study aims to create a more comfortable dental experience for these children. This research could potentially inform broader pediatric dentistry practices, making dental care more accessible and less distressing for children with sensory sensitivities.
The purpose of this study is to determine whether a handheld mirror helps to reduce child behavior problems during dental treatment. It will be tested by randomized crossover design. Child participants will receive dental treatment under two conditions: during one of the treatment days the child will be given a handheld mirror; another treatment will be done without the child having the mirror. Each condition will be assign on separate days, and the day, which the child has the mirror, will be assigned by chance.
Children undergoing dental restorative or surgical procedures require injection of local anesthetic. The injection procedure is often the most anxiety-producing stimulus for children during dental care, when children demonstrate the highest level of emotional distress. Several studies have investigated various interventions, such as distraction, hypnosis, and cognitive behavioral therapy to ease this stress. Animal-assisted therapy (e.g. the presence of a therapy dog) may be a promising strategy for managing anxiety in young dental patients. However, no studies have explored the potential benefits of using therapy dogs specifically during the administration of local anesthesia in pediatric dental patients. The objective of this randomized controlled trial is to investigate the effects of therapy dogs on pediatric dental patients during local anesthesia administration.
As dental practices reopen their practices during a global pandemic, the risk of 2019 novel coronavirus (COVID-19) infection that dental hygienists face in providing dental care remains unknown. Estimating the occupational risk of COVID-19, and producing evidence on the types of infection control practices and dental practices that may affect COVID-19 risk, is therefore imperative. These findings could be used to describe the prevalence and incidence of COVID-19 among dental hygienists, determine what infection control steps dental hygienists take over time, describe dental hygienists' employment during the COVID-19 pandemic, and estimate whether infection control adherence in dental practice is related to COVID-19 incidence.
The goal of this project is to examine the efficacy of a sensory adapted dental environment (SADE) for children who have difficulty tolerating oral care in the dental clinic. The investigators hypothesize that adapting the sensory environment in the dental office by modifying the sounds, sights,and tactile experiences will result in decreased anxiety, increased cooperation, and fewer behavior problems for children with Autism Spectrum Disorders (ASD). This has the potential to contribute to increased child comfort as well as safer, more efficient, and less costly treatment for a large population, as potentially more than one-fourth of all children may benefit from a sensory adapted dental environment.
The purpose of this study was to characterize mood changes during nitrous oxide inhalation in patients with different levels of preoperative dental anxiety.