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The purpose of this study is to compare an intervention for dental fear to the usual approach (i.e., whatever participants’ dentist typically does to help participants manage their fear). The dental fear intervention has 2 separate steps. Step 1 (the less intensive or ‘light touch’ intervention step) involves using a mobile application (app). Step 2 consists of a one-hour telehealth session with a mental health provider tailored to individualized dental fear.
This is a randomized study. The time spent participating in the study will depend on which study condition(s) participants are randomly assigned to. Because this study compares the dental fear intervention to the standard approach, 25% of participants will not get the intervention during the study period. These participants (called controls) will be offered the opportunity to provide feedback about their experiences with dentists. Participants will be offered the intervention free of charge at the conclusion of the study.
For each step of the intervention (Dental FearLess app or one-on-one session) relative to treatment as usual, the investigators hypothesize that participants will show greater declines in self-reported dental fear and improved oral health-related quality of life at post-treatment and follow-up period. De-identified attendance records will be collected from dental practices.
Source: View full study details on ClinicalTrials.gov
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
The device used in the study, Optibond Universal (OBU) is a single component universal dental adhesive intended for direct and indirect dental restorations. OBU is formulated to provide reliable bond strength with any etch technique, on all common substrates and in combination with any resin cement without auxiliary products (silane or metal primers) even in absence of light. OBU is intended for general population use by a dental professional.
OBU contains an acidic component to etch the tooth surface in order to allow the adhesive to mechanically adhere to the prepared tooth surface. The adhesive can be used with light or without light cured prior to application of the restorative material. This allows for the adhesive to mechanically and chemically bond to the applied restorative material. OBU is formulated to provide a reliable bond strength, and it’s compatible with all etching modes (self-etch, selective etch, and total etch).
Aim/Hypothesis/Objective The primary objective of this study is to evaluate the clinical performance of OBU used in the intended clinical conditions.
The device will undergo evaluation in the following categories:
Functional Properties Endodontic posts Ceramic restorations Composite and metal crowns Pretreatment for indirect restorations Core build-ups
Endpoints:
Primary endpoints:
Evaluation of clinical safety and performance of OBU, a single component universal dental adhesive intended for indirect dental restorations according to manufacturer’s Instruction For Use.
(Indirect metal restoration is defined as any restoration made of precious or non-precious alloy such as inlays, onlays, porcelain fused to metal, metal full coverage crown, metal full coverage fixed partial denture). All implant restorations are excluded.
Secondary endpoints:
Post-operative sensitivity, retention, general periodontal health, and general optical properties after baseline, 6 months, 1 year and 2 years post-placement.
The hypothesis to be tested is that OBU is safe and effective in clinical settings when the device is used according to manufacturer’s instructions:
H0: P ̂_T-P ̂_C≥ ∆ HA: P ̂_T-P ̂_C< ∆ Where ∆ (delta) refers to the non-inferiority margin set at 10%.
Source: View full study details on ClinicalTrials.gov
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Early childhood caries (ECC) is a potentially painful and debilitating disease, which represents a significant public health problem among young children. There are profound disparities in ECC experiences such that children from minority and low-income families suffer a disproportionate share of the disease burden. The likelihood of parents of high-ECC risk young children seeking prevention in dental facilities is low; therefore, there is a need to increase preventive dental opportunities where these children already seek health care services. In particular, there is an urgent need to develop and evaluate ECC behavioral interventions for use in public health settings attended by high-risk children. Many authors recommend early implementation of oral health education as one means of preventing ECC. However, major issues discussed in the oral health promotion literature involve a lack of effectiveness among programs based on education alone, as well as a lack of high quality preventive interventions using evidence-based psychological and behavioral strategies.
Our research team has been the first to introduce to the ECC prevention arena the self-determination theory (SDT) of motivation, internalization, and healthy functioning, proven effective in promoting positive behavioral changes in several other fields, including oral health care. The investigators have demonstrated that SDT has great promise as a motivational approach by providing evidence, based on results from our R21 (R21-DE016483) study, of the effectiveness of SDT in changing several desirable oral health behaviors for ECC prevention. Building upon the rigor of our previous experience and formative research work in the past several years, the investigators propose a Stage II NIH Model research project that will compare the efficacy of autonomy-supportive videotaped oral health messages framed by SDT to more traditional neutral videotaped messages. The investigators intend to recruit 634 pregnant mothers enrolled in Iowa Women, Infants and Children (WIC) Supplemental Nutrition Programs and follow them until their future child is 36 months old. The primary outcome of interest will be children’s caries status. Secondary outcomes will be changes in children’s oral health behaviors conducive to better oral hygiene and dietary habits, as well as lower levels of dental plaque and mutans streptococci.
Detailed Description:
The UH3 study is considered a Stage II research according to the NIH Stage Model and builds directly upon the rigor of our previous formative research work, including a study supported by R21 DE016483-02. The R21 study tested the effectiveness of an autonomy-supportive videotaped oral health message informed by the self-determination theory (SDT) as a preventive behavioral approach for ECC among WIC-enrolled 12- to 49-month old children and their mothers. This grant was exploratory in nature and did not allow our research team to have a control group. In order to test the study intervention against the standard dental educational brochures, funding was obtained through the University of Iowa (UI) College of Dentistry to recruit participants to a control group. This concurrent control group was recruited to facilitate future study planning, including estimation of effect sizes. Results from the R21 study provided evidence of the effectiveness of the SDT-framed autonomy-supportive videotaped intervention in changing several oral health behaviors for ECC prevention: increased children’s daily brushing habits, use of fluoridated toothpaste, mother’s lifting their children’s lip to look for early signs of ECC, and compliance with the consumption of no more than 4 ounces of 100% juice daily. Additional behavioral changes included decreased nighttime feeding other than water, and reduced number of daily cariogenic snacks consumed. The future proposed UH3 study will improve upon our previous investigations in two ways. First, the investigators will enhance the expected effectiveness of our experimental manipulation by creating and implementing a more research-informed age targeted oral health message. Second, the UH3 mechanism will allow us to enhance our capacity to assess the effectiveness of the SDT-derived videotaped oral health message compared to a control group with an optimal, sufficiently powered sample size. The investigators believe they have a strong scientific foundation for this project based on the rigor of our prior research efforts. Our approach will have a broader impact in that it tests a low-cost behavioral intervention that can be used in WIC clinics and other public health settings across the nation. As such, the use of evidence-based autonomy-supportive messages could efficiently disseminate an important and effective health promotion message that has great generalizability and the potential to greatly reduce the burden of ECC among some of the most vulnerable populations.
Source: View full study details on ClinicalTrials.gov
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Molar incisor hypomineralization (MIH) is defined as a qualitative enamel defect of unknown etiology that affects one or more permanent molars and may also affect the permanent incisors. Clinically, the presentation of MIH depends on severity: lesions can range from mild, with white to yellow-brown discolored opacities, to severe, with extensive post-eruptive enamel breakdown and atypical caries. Hypomineralized enamel has increased porosity with reduced mineral content, which promotes bacteria penetration, resulting in development and rapid progression of dental caries and subclinical chronic pulp inflammation.
Treatment of teeth affected by MIH pose a clinical challenge due to several reasons. Post-eruptive breakdown of inadequately formed enamel exposes underlying dentin, resulting in hypersensitivity to hot and cold temperatures, air, and water. This increased tooth sensitivity leads to poor oral hygiene and subsequent plaque retention. Additionally, chronic subclinical inflammation of the pulp hypersensitizes the gamma-aminobutyric acid (GABA) receptors in the pulp nerve tissue and reduces the pain threshold in these teeth. This weakens the action of local anesthetics making it difficult to achieve adequate pain control during dental treatment.
Recently, 38% silver diamine fluoride (SDF), a solution of silver fluoride and ammonium ions, has been shown to be effective in tooth desensitization by blocking dentinal tubules and promoting remineralization of demineralized tooth structure. SDF can be useful in managing symptomatic MIH-affected teeth by stimulating the production of calcium fluoride and silver iodide, both of which are able to occlude dentinal tubules and reduce their patency.
The purpose of this randomized, controlled clinical study is to evaluate the efficacy of local anesthesia on MIH-affected molars treated with 38% SDF. The goal is to determine if pre-operative application of SDF results in improved local anesthesia and decrease in procedural pain in MIH affected teeth, thereby addressing an important challenge in routine clinical practice and contributing to the development of a treatment protocol for MIH affected molars.
Source: View full study details on ClinicalTrials.gov
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Objective 1): To assess HPV-related Oropharyngeal Cancer (OPC) knowledge, perceptions, practices and barriers of general dentists and dental hygienists in North Carolina (NC).
Objective 2): To understand key infrastructure elements and policies, as well as HPV prevention strategies in place at East Carolina University School of Dental Medicine Community Service-Learning Centers (CSLCs) and their partnering Community Health Clinics/Federally Qualified Health Clinics (FQHCs).
Objective 3): Develop and assess the feasibility of a model for collaborative and effective HPV prevention strategies between dental practices (CSLCs) and co-located Community Health Clinics (FQHCs).
Hypotheses:
H1. It is hypothesized that HPV OPC knowledge, perceptions, and practices will be informed by level of HPV health literacy; where higher levels of HPV health literacy will correlate with higher levels of HPV prevention practices (i.e., oral cancer screening, education on HPV risk behaviors, HPV vaccine recommendation). The investigators expect to find gaps in one or more of the surveyed areas (knowledge, attitudes, societal norms, perceived behavior control, and current prevention practices) among dentists and dental hygienists. Last, the investigators expect to find barriers to HPV prevention practices among our sample.
H2: It is hypothesized that there will be key infrastructure elements and policies identified through interviews that will both inhibit and facilitate the navigation of patients for HPV vaccination between dental clinics (CSLCs) and partnering health clinics (community clinics/FQHCs). The investigators also expect to find a variation of HPV prevention strategies currently being employed at CSLCs and partnering community clinic/FQHCs.
H3: It is hypothesized that the investigators will employ the data identified in Objectives 1 and 2 to develop a feasible model for collaborative and effective HPV prevention between dental clinics (CSLCs) and health clinics (FQHCs). Specifically, the investigators will address barriers identified in Objective 2 and capitalize on the facilitators identified to develop a model of HPV prevention care and navigation between dental clinics (CSLCs) and health clinics (FQHCs). This model can then be evaluated for effectiveness and serve as a model for replication in other rural and under-resourced settings.
Source: View full study details on ClinicalTrials.gov
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Participants will receive the Ask-Advise-Refer intervention which includes an oral health practitioner asking about their tobacco use, advising them to quit smoking, and referring them to the state quitline. They will also receive a sample bag including information about smoking and oral health, the state quitline, and an electric toothbrush.
All patients will be asked if they smoke, advised to quit, and referred to the state quitline
Source: View full study details on ClinicalTrials.gov
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Participants will receive a single oral dose of one Naproxen Sodium tablet with one Placebo capsule.
Naproxen Sodium will be administered orally.
Drug: Placebo
Placebo will be administered orally.
Source: View full study details on ClinicalTrials.gov
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Measured by passing a strip between the contra-lateral upper and lower posterior natural teeth with the child biting into maximum intercuspation. If the strip passes without resistance between teeth anterior or posterior to the SSC there is no occlusal contact.
Measured by passing a strip between the contra-lateral upper and lower posterior natural teeth with the child biting into maximum intercuspation. If the strip passes without resistance between teeth anterior or posterior to the SSC there is no occlusal contact.
Measured by passing a strip between the contra-lateral upper and lower posterior natural teeth with the child biting into maximum intercuspation. If the strip passes without resistance between teeth anterior or posterior to the SSC there is no occlusal contact.
Measured by passing a strip between the contra-lateral upper and lower posterior natural teeth with the child biting into maximum intercuspation. If the strip passes without resistance between teeth anterior or posterior to the SSC there is no occlusal contact.
Over lap of the upper and lower incisors will be measured in millimeters.If incisors are missing, canines will be used.
Over lap of the upper and lower incisors will be measured in millimeters.If incisors are missing, canines will be used.
Over lap of the upper and lower incisors will be measured in millimeters.If incisors are missing, canines will be used.
Over lap of the upper and lower incisors will be measured in millimeters.If incisors are missing, canines will be used.
In the Modified Plaque Index, a score of 0 (no plaque), 1 (thin visible plaque, difficult to identify), or 2 (thick visible plaque, easily detected) is assigned
In the Modified Plaque Index, a score of 0 (no plaque), 1 (thin visible plaque, difficult to identify), or 2 (thick visible plaque, easily detected) is assigned
In the Modified Plaque Index, a score of 0 (no plaque), 1 (thin visible plaque, difficult to identify), or 2 (thick visible plaque, easily detected) is assigned
In the Modified Plaque Index, a score of 0 (no plaque), 1 (thin visible plaque, difficult to identify), or 2 (thick visible plaque, easily detected) is assigned
Gingival status is assigned a score of 0 (normal gingiva, natural coral pink gingival with no e/o inflammation), 1 (mild inflammation, slight changes in color, slight edema, no bleeding on probing), 2 (moderate inflammation, redness, edema, and glazing, bleeding on probing), or 3 (severe inflammation, marked redness and edema/ulceration/tendency to bleed spontaneously).
Gingival status is assigned a score of 0 (normal gingiva, natural coral pink gingival with no e/o inflammation), 1 (mild inflammation, slight changes in color, slight edema, no bleeding on probing), 2 (moderate inflammation, redness, edema, and glazing, bleeding on probing), or 3 (severe inflammation, marked redness and edema/ulceration/tendency to bleed spontaneously).
Gingival status is assigned a score of 0 (normal gingiva, natural coral pink gingival with no e/o inflammation), 1 (mild inflammation, slight changes in color, slight edema, no bleeding on probing), 2 (moderate inflammation, redness, edema, and glazing, bleeding on probing), or 3 (severe inflammation, marked redness and edema/ulceration/tendency to bleed spontaneously).
Gingival status is assigned a score of 0 (normal gingiva, natural coral pink gingival with no e/o inflammation), 1 (mild inflammation, slight changes in color, slight edema, no bleeding on probing), 2 (moderate inflammation, redness, edema, and glazing, bleeding on probing), or 3 (severe inflammation, marked redness and edema/ulceration/tendency to bleed spontaneously).
Source: View full study details on ClinicalTrials.gov
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Behavioral: Peer-led Oral Health Recovery Group
The interactive Oral Health Recovery group will be centered around the tailored materials previously developed, with topics such as “it’s never too late to make a change,” “oral health and whole health,” “taking care of your teeth,” and “going to the dentist.”
Source: View full study details on ClinicalTrials.gov
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Primary Objective: Assess the efficacy of the BR2S intervention program in the context of established parenting education systems (e.g., Head Start and Oregon Parenting Education Collaborative). A sub-sample of participants will complete an observational interaction procedure as measured by The Dyadic Parent-Child Interactive Coding System.
Secondary Objectives:
Primary Endpoint: This study will provide outcomes for a primary endpoints that will compare BeReady2Smile to comparison (usual care video) as measured by the Plaque Control Record. The Plaque Control Record is a very simple percentage or score of the total amount of bacteria present in the mouth. A tooth has 4 surfaces at the gum line being; the cheek side, tongue side, front side, and back side. A hygienist will disclose or stain up the Bacterial Plaque to show where one may be missing.
Secondary Endpoints: 1. With this study’s data, additional secondary endpoints the investigators will investigate the effects of BeReady2Smile video alone and BeReady2Smile video + app compared to the usual-care video as well as the impact of a coach (Oral Health Educator). The investigators will also measure behavioral change, self-efficacy, establishment of dental home knowledge, and attitudes. 2. User experience will be measured by Coach Feedback, App feedback, and Video satisfaction.
Study Population: Caregivers, who have a child 0-6 years, enrolled in a participating social service agency providing parenting education, such as Head Start; and are able to communicate in English or Spanish.
Phase* or Stage: 2
Description of Sites/Facilities Enrolling Participants: The study is being conducted at ORBIS, where the investigators, and bachelor- and masters-level recruitment staff, computer programmers, data management staff, and data analyst are housed. Enrollment of eligible parents, technological adaptations for the intervention, data analysis, and manuscript production will be completed there.
Agency staff at Head Start and Oregon Parenting Education Collaborative will inform parents about the project and will get parent permission to share their contact information with the family recruiters at ORBIS.
Description of Study Intervention/Experimental Manipulation: BR2S is a coordinated oral health prevention intervention program to promote dental health targeted at parents of young children attending parenting education classes and families receiving home visiting services through Head Start. Participants will be randomized in one of 4 experimental conditions (Usual care video; BR2S video; BR2S video + app; BR2Svideo + app + coach) with the primary comparison being between those who were exposed to one or more component of BR2S and those who received a usual care video.
Source: View full study details on ClinicalTrials.gov
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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