PlaqueBR2S-IINCT05321719
Multi-Media Parent-based Intervention to Promote Dental Hygiene Among Young Children: BeReady2Smile II
A study testing Comparison Condition, BeReady2Smile video only and BeReady2Smile video and BeReady2Smile app completely self-guided in people with Plaque, run by Oregon Research Behavioral Intervention Strategies, Inc. at 1 site in United States.
Trial summary
"BeReady2Smile (BR2S)", based on successful results from the Phase I SBIR feasibility/usability research of the prototype, is a coordinated oral health prevention intervention program that provides empirically-supported behavioral parent training (BPT) skills and oral health instruction through the use of video and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plaque
- What is being tested?
- Comparison Condition, BeReady2Smile video only and BeReady2Smile video and BeReady2Smile app completely self-guided
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2023to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a child 0-6 years enrolled in a participating social service agency providing parent education, such as Head Start; be able to communicate in English or Spanish.
- Exclusion Criteria: Individuals who meet the following criteria will be excluded from the study:
- Parental psychosis or other major mental illness or cognitive disability that would interfere with meaningful participation
- Babies without teeth
- Children with allergies to food dye.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Research Behavioral Intervention Strategies, Inc.
Springfield, Oregon, 97477
About this study
Official title: Multi-Media Parent-based Intervention to Promote Dental Hygiene Among Young Children: BeReady2Smile
"BeReady2Smile (BR2S)", based on successful results from the Phase I SBIR feasibility/usability research of the prototype, is a coordinated oral health prevention intervention program that provides empirically-supported behavioral parent training (BPT) skills and oral health instruction through the use of video and mobile/web- application. In this Phase II project, BR2S will be evaluated for efficacy relative to a usual care control. The investigators expect BR2S to improve outcomes on behavioral change, self-efficacy, establishment of a dental home, knowledge, and attitudes in real settings relative to our usual care condition. The outcome measures include a direct clinical dental measure as well as observational measures of parental behavior.
The study will also provide important information regarding the various types and combinations of BeReady2Smile product components for dissemination. The long-term goal of the program is to help parents provide the foundation for a lifetime free from preventable oral disease.
Read the detailed description
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:
- Assess relative contribution of BR2S components to outcomes to provide insight on options for dissemination using Usual Care Video only (UC control) or BeReady2Smile Video only or BeReady2Smile video + app or BeReady2Smile Video + app + coach.
- Assess aspects of user experience with the BR2S program
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.
- Conditions
- Plaque
- Being tested
- Comparison Condition, BeReady2Smile video only, BeReady2Smile video and BeReady2Smile app completely self-guided, "Complete" BeReady2Smile video and BeReady2Smile app guided by a Coach
- Medical subject headings
- Plaque, Amyloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparison ConditionBehavioural
In this Phase II project, BR2S will be evaluated for efficacy relative to a usual care control. Investigators expect BR2S to improve outcomes on behavioral change, self-efficacy, establishment of a dental home, knowledge, and attitudes in real settings relative to the usual care condition. The outcome measures include a direct clinical dental measure as well as observational measures of parental behavior. The study will also provide important information regarding the various types and combinations of BeReady2Smile product components for dissemination. The long-term goal of the program is to help parents provide the foundation for a lifetime free from preventable oral disease.
BeReady2Smile video onlyBehavioural
The video will be viewed at the Head Start site after informed consent and T1 questionnaires and plaque assessment. The video will include concrete demonstrations and feature diversity in settings and actors in video content derived from actual peer-based parenting education sessions. Parents' ability to "see themselves" in the content makes them more likely to engage in discussions about dental health. Supporting these conversations has been identified as an important need. For example, in a recent environmental scan prepared by the Association of State and Territorial Dental Directors the lack of communication strategies was identified as a gap in oral health educational resources. Specifically mentioned was the lack of oral health curricula that support interactive communication between families and home visitors. Families struggle with such dialogues.
BeReady2Smile video and BeReady2Smile app completely self-guidedBehavioural
In addition to the BeReady2Smile video as described above, the BeReady2Smile app includes: (a) presentation of concepts, behaviors, and examples via video and text, (b) electronically presented check-in questions recorded to a database for review, (c) capture of a 5-minute video of parent-child interactions uploaded for later review by the parent, using a mobile application, (d) daily dental activities (homework), and (e) program feedback recorded to the database. BeReady2Smile will be designed such that before the parent can go on to a new area of learning, the parent must complete the previous lesson. Participants can go back and review previous material in a non-linear format. The database and log-files record all computer activities to track use of each intervention component.
"Complete" BeReady2Smile video and BeReady2Smile app guided by a CoachBehavioural
In addition to the BeReady2Smile video and BeReady2Smile app described above, the "complete" intervention includes support via phone and text from a trained facilitator/coach who builds supportive one-on-one relationships with the parent and gives feedback on parent-recorded videos of parent-child interactions of tooth-brushing, designed to facilitate learning and promote engagement with their oral health professional; and tools to create a long-term follow-up plan. Dental behaviors will be tailored for children's developmental level (e.g. twice daily tooth brushing for preschoolers and limiting sugar sweetened beverages or milk in bottles at bed for infants).
| Study group | Role | What they receive |
|---|---|---|
| Experimental: BeReady2Smile Video, App, & Coach | Experimental | This arm will test the feasibility of the BeReady2Smile Video and App to promote dental health of young children with a parent education program. Receives: Behavioral: Comparison Condition |
| Assess the Contributions of BRS2 Components | Experimental | Outcomes of video, app, and coach Receives: Behavioral: BeReady2Smile video only; Behavioral: BeReady2Smile video and BeReady2Smile app completely self-guided; Behavioral: "Complete" BeReady2Smile video and BeReady2Smile app guided by a Coach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in parental attitudes towards child tooth brushing and caries
Four scales are included in the questionnaire that were developed for the international study of Adair and colleagues. Included in this study were:
- 'Importance and Intention to Brush Child's Teeth' (five items),
- 'Parental Efficacy in Relation to Child Tooth brushing' (6 items),
- 'Perceived Seriousness of Tooth Decay in Children' (seven items) and
- 'Chance Control - Decay Occurs by Chance' (5 items). Response options range from 'strongly agree' (=1) to 'strongly disagree' (=5).
Measured: T1 (Baseline) and T3 (three month)
Secondary outcomes (7)
Knowledge
As part of the pre- and post-intervention questionnaires, parents will complete a 15-item knowledge inventory of young children's oral health. The items include recommendations for home hygiene and dental health (nine items), statements about the caries process (two items) and dental development (three items). For each item, parents indicated their level of knowledge as 'didn't know', 'sorta know' and 'know for sure'; item scoring ranges from 1 to 3 points, respectively.
Measured: T1 (Baseline) and T3 (three month)
Parents' confidence in brushing
Investigators will use a Likert scale to determine parents' confidence in brushing their child's teeth twice a day. The question asked was 'If you already don't brush twice a day, how confident are you that, if you decided to, you could brush your child's teeth twice (or almost always twice) a day?' Parents responded on a scale of 1-10 how motivated they are to change this behavior.
Measured: T1 (Baseline) and T3 (three month)
Connection to Dental Services "Dental Home"
The dental home concept has been by the American Academy of Pediatric Dentistry that states, "the dental home is the ongoing relationship between the dentist and the patient, inclusive of all aspects of oral health care delivered in a comprehensive, continuously accessible, coordinated, and family-centered way." This concept is intimately linked to a cluster of additional progressive policies currently being advanced by pediatric dentistry including the age one dental visit, outreach to Head Start populations, updating state Medicaid periodicity schedules, and refining clinical care through risk assessment and risk-based interventions. Parents will be asked to provide past dental services to ascertain the presence of an ongoing relationship with a dentist.
Measured: T1 (Baseline) and T3 (three month)
Clinical Dental Exam for Plaque
Children of parents participating in the research will be administered the Plaque Control Record by a Dental Hygienist. The Plaque Control Record was developed to give the therapist, hygienist, or dental educator a simple method of recording the presence of the plaque on individual tooth surfaces: (a) Mesial, (b) Distal (d) Buccal and (d) Lingual. At the exam, a suitable disclosing solution such as Bismarck Brown, Diaplac or similar is painted on all exposed tooth surfaces. After the patient has rinsed, the hygienist (using an explorer or a tip of a probe) examines each stained surface for soft accumulations at the dentogingival junction and are recorded by making a dash in the appropriate spaces on the record form. Those surfaces, which do not have soft accumulations at the dentogingival junction, are not recorded. The index is calculated by dividing the number of plaque containing surfaces by the total number of available surfaces.
Measured: T1 (Baseline) and T3 (three month)
Usage of Application
Throughout the clinical trial all participant activity both online and through the app will be recorded to a MySQL database. Process indicants of acceptability included the following indices of participation: (1) attrition; (2) session completion; and (3) extent of intervention participation (e.g., time online).
Measured: Once a week through study completion at 12 weeks
Satisfaction of Video and App
Parents will rate the video and app on a 4-point scale from 1="not at all" (negative) to 4="Very" (positive). Parents were asked questions such as "How reasonable did you find the Video", "How much did you like the video for learning information taught", "How clear was information taught", "How useful did you find BeReady2Smile" and "I would recommend the BR2S video to other parents".
Measured: T2 (one month) and T3 (three month)
Direct observation of Parenting Behavior
An observational assessment of parenting behavior during mother-child interactions, consisting of three 5-min tasks, tooth brushing, a child-led play session, and a parent-led play session/clean-up task. The interactions were coded using the Dyadic Parent-Child Interaction Coding System (Eyberg, et al., 2013). Coders were blind to group and assessment period, and 20% of interactions were double coded for reliability purposes.
Measured: T1 (Baseline) and T3 (three month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start10 Apr 2023
- Primary completion24 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for PlaqueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Research Behavioral Intervention Strategies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Sponsor
- Investigators
- David R Smith, PhD, Principal investigator, Oregon Research Behavioral Intervention Strategies, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05321719
- Sponsor's protocol ID
- DE027001-02
- Other IDs
- 5R44DE027001-03
- Acronym
- BR2S-II
- Status last verified
- Oct 2025
- First submitted
- 26 Jan 2022
- Last updated
- 8 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
American Academy on Pediatric Dentistry Council on Clinical Affairs. Policy on early childhood caries (ECC): unique challenges and treatment option. Pediatr Dent. 2008-2009;30(7 Suppl):44-6. No abstract available.
PubMed 19216382Section On Oral Health. Maintaining and improving the oral health of young children. Pediatrics. 2014 Dec;134(6):1224-9. doi: 10.1542/peds.2014-2984.
PubMed 25422016Barkley RA. Attention-deficit/hyperactivity disorder, self-regulation, and time: toward a more comprehensive theory. J Dev Behav Pediatr. 1997 Aug;18(4):271-9.
PubMed 9276836Brinkmeyer, M., & Eyberg, S. M. (2003). Parent-child interaction therapy for oppositional children. In A.E. Kazdin & J. R. Weisz (Eds.), Evidence-based psychotherapies for children and adolescents (pp. 204-223). New York: Guilford.
Forgatch, M. S., & Patterson, G. R. (2010). Parent Management Training -- Oregon Model: An intervention for antisocial behavior in children and adolescents. In J. R. Weisz & A. E. Kazdin (Eds.), Evidence based psychotherapies for children and adolescents (2nd ed., pp. 159-178). New York, NY: Guilford.
Huebner CE, Riedy CA. Behavioral determinants of brushing young children's teeth: implications for anticipatory guidance. Pediatr Dent. 2010 Jan-Feb;32(1):48-55.
PubMed 20298653Kazdin AE. Evidence-based treatment and practice: new opportunities to bridge clinical research and practice, enhance the knowledge base, and improve patient care. Am Psychol. 2008 Apr;63(3):146-59. doi: 10.1037/0003-066X.63.3.146.
PubMed 18377105Pine CM, Adair PM, Petersen PE, Douglass C, Burnside G, Nicoll AD, Gillett A, Anderson R, Beighton D, Jin-You B, Broukal Z, Brown JP, Chestnutt IG, Declerck D, Devine D, Espelid I, Falcolini G, Ping FX, Freeman R, Gibbons D, Gugushe T, Harris R, Kirkham J, Lo EC, Marsh P, Maupome G, Naidoo S, Ramos-Gomez F, Sutton BK, Williams S. Developing explanatory models of health inequalities in childhood dental caries. Community Dent Health. 2004 Mar;21(1 Suppl):86-95.
PubMed 15072477Webster-Stratton, C., & Reid, M. J. (2003). Strengthening social and emotional competence in young children--the foundation for early school readiness and success: Incredible Years Classroom Social Skills and Problem-Solving curriculum. Infants and Young Children, 17(2), 96-113.
Adair PM, Pine CM, Burnside G, Nicoll AD, Gillett A, Anwar S, Broukal Z, Chestnutt IG, Declerck D, Ping FX, Ferro R, Freeman R, Grant-Mills D, Gugushe T, Hunsrisakhun J, Irigoyen-Camacho M, Lo EC, Moola MH, Naidoo S, Nyandindi U, Poulsen VJ, Ramos-Gomez F, Razanamihaja N, Shahid S, Skeie MS, Skur OP, Splieth C, Soo TC, Whelton H, Young DW. Familial and cultural perceptions and beliefs of oral hygiene and dietary practices among ethnically and socio-economicall diverse groups. Community Dent Health. 2004 Mar;21(1 Suppl):102-11.
PubMed 15072479Huebner CE, Milgrom P. Evaluation of a parent-designed programme to support tooth brushing of infants and young children. Int J Dent Hyg. 2015 Feb;13(1):65-73. doi: 10.1111/idh.12100. Epub 2014 Jul 29.
PubMed 25070036Edelstein, B. L. (2008). Environmental factors in implementing the dental home for all young children. National Oral Policy Center at Children's Dental Health Project.
American Academy of Pediatric Dentistry reference manual 2007-2008. Pediatr Dent. 2007-2008;29(7 Suppl):1-271. No abstract available.
PubMed 18268823O'Leary TJ, Drake RB, Naylor JE. The plaque control record. J Periodontol. 1972 Jan;43(1):38. doi: 10.1902/jop.1972.43.1.38. No abstract available.
PubMed 4500182
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Media Parent-based Intervention to Promote Dental Hygiene Among Young Children: BeReady2Smile
- ClinicalTrials.gov ID
- NCT05321719
- Acronym / sponsor ID
- BR2S-II / DE027001-02
- Conditions
- Plaque
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- Oregon Research Behavioral Intervention Strategies, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- 10 Apr 2023 (actual)
- Primary completion
- 24 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 11 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
"BeReady2Smile (BR2S)", based on successful results from the Phase I SBIR feasibility/usability research of the prototype, is a coordinated oral health prevention intervention program that provides empirically-supported behavioral parent training (BPT) skills and oral health instruction through the use of video and mobile/web- application. In this Phase II project, BR2S will be evaluated for efficacy relative to a usual care control. The investigators expect BR2S to improve outcomes on behavioral change, self-efficacy, establishment of a dental home, knowledge, and attitudes in real settings relative to our usual care condition. The outcome measures include a direct clinical dental measure as well as observational measures of parental behavior.
The study will also provide important information regarding the various types and combinations of BeReady2Smile product components for dissemination. The long-term goal of the program is to help parents provide the foundation for a lifetime free from preventable oral disease.
Detailed description
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:
- Assess relative contribution of BR2S components to outcomes to provide insight on options for dissemination using Usual Care Video only (UC control) or BeReady2Smile Video only or BeReady2Smile video + app or BeReady2Smile Video + app + coach.
- Assess aspects of user experience with the BR2S program
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: BeReady2Smile Video, App, & Coach | Experimental | Behavioral: Comparison ConditionThis arm will test the feasibility of the BeReady2Smile Video and App to promote dental health of young children with a parent education program. |
| Assess the Contributions of BRS2 Components | Experimental | Behavioral: BeReady2Smile video only, Behavioral: BeReady2Smile video and BeReady2Smile app completely self-guided, Behavioral: "Complete" BeReady2Smile video and BeReady2Smile app guided by a CoachOutcomes of video, app, and coach |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Have a child 0-6 years enrolled in a participating social service agency providing parent education, such as Head Start; be able to communicate in English or Spanish.
- Exclusion Criteria: Individuals who meet the following criteria will be excluded from the study:
- Parental psychosis or other major mental illness or cognitive disability that would interfere with meaningful participation
- Babies without teeth
- Children with allergies to food dye.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comparison ConditionIn this Phase II project, BR2S will be evaluated for efficacy relative to a usual care control. Investigators expect BR2S to improve outcomes on behavioral change, self-efficacy, establishment of a dental home, knowledge, and attitudes in real settings relative to the usual care condition. The outcome measures include a direct clinical dental measure as well as observational measures of parental behavior. The study will also provide important information regarding the various types and combinations of BeReady2Smile product components for dissemination. The long-term goal of the program is to help parents provide the foundation for a lifetime free from preventable oral disease. | Behavioural | Experimental: BeReady2Smile Video, App, & Coach |
| BeReady2Smile video onlyThe video will be viewed at the Head Start site after informed consent and T1 questionnaires and plaque assessment. The video will include concrete demonstrations and feature diversity in settings and actors in video content derived from actual peer-based parenting education sessions. Parents' ability to "see themselves" in the content makes them more likely to engage in discussions about dental health. Supporting these conversations has been identified as an important need. For example, in a recent environmental scan prepared by the Association of State and Territorial Dental Directors the lack of communication strategies was identified as a gap in oral health educational resources. Specifically mentioned was the lack of oral health curricula that support interactive communication between families and home visitors. Families struggle with such dialogues. | Behavioural | Assess the Contributions of BRS2 Components |
| BeReady2Smile video and BeReady2Smile app completely self-guidedIn addition to the BeReady2Smile video as described above, the BeReady2Smile app includes: (a) presentation of concepts, behaviors, and examples via video and text, (b) electronically presented check-in questions recorded to a database for review, (c) capture of a 5-minute video of parent-child interactions uploaded for later review by the parent, using a mobile application, (d) daily dental activities (homework), and (e) program feedback recorded to the database. BeReady2Smile will be designed such that before the parent can go on to a new area of learning, the parent must complete the previous lesson. Participants can go back and review previous material in a non-linear format. The database and log-files record all computer activities to track use of each intervention component. | Behavioural | Assess the Contributions of BRS2 Components |
| "Complete" BeReady2Smile video and BeReady2Smile app guided by a CoachIn addition to the BeReady2Smile video and BeReady2Smile app described above, the "complete" intervention includes support via phone and text from a trained facilitator/coach who builds supportive one-on-one relationships with the parent and gives feedback on parent-recorded videos of parent-child interactions of tooth-brushing, designed to facilitate learning and promote engagement with their oral health professional; and tools to create a long-term follow-up plan. Dental behaviors will be tailored for children's developmental level (e.g. twice daily tooth brushing for preschoolers and limiting sugar sweetened beverages or milk in bottles at bed for infants). | Behavioural | Assess the Contributions of BRS2 Components |
Primary outcome
Change in parental attitudes towards child tooth brushing and caries
Time frame: T1 (Baseline) and T3 (three month)
Four scales are included in the questionnaire that were developed for the international study of Adair and colleagues. Included in this study were: 1. 'Importance and Intention to Brush Child's Teeth' (five items), 2. 'Parental Efficacy in Relation to Child Tooth brushing' (6 items), 3. 'Perceived Seriousness of Tooth Decay in Children' (seven items) and 4. 'Chance Control - Decay Occurs by Chance' (5 items). Response options range from 'strongly agree' (=1) to 'strongly disagree' (=5).
7 secondary outcomes
Knowledge
Time frame: T1 (Baseline) and T3 (three month)
Parents' confidence in brushing
Time frame: T1 (Baseline) and T3 (three month)
Connection to Dental Services "Dental Home"
Time frame: T1 (Baseline) and T3 (three month)
Clinical Dental Exam for Plaque
Time frame: T1 (Baseline) and T3 (three month)
Usage of Application
Time frame: Once a week through study completion at 12 weeks
Satisfaction of Video and App
Time frame: T2 (one month) and T3 (three month)
Direct observation of Parenting Behavior
Time frame: T1 (Baseline) and T3 (three month)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2025.
- Background: PubMed 19216382American Academy on Pediatric Dentistry Council on Clinical Affairs. Policy on early childhood caries (ECC): unique challenges and treatment option. Pediatr Dent. 2008-2009;30(7 Suppl):44-6. No abstract available.
- Background: PubMed 25422016Section On Oral Health. Maintaining and improving the oral health of young children. Pediatrics. 2014 Dec;134(6):1224-9. doi: 10.1542/peds.2014-2984.
- Background: PubMed 9276836Barkley RA. Attention-deficit/hyperactivity disorder, self-regulation, and time: toward a more comprehensive theory. J Dev Behav Pediatr. 1997 Aug;18(4):271-9.
- BackgroundBrinkmeyer, M., & Eyberg, S. M. (2003). Parent-child interaction therapy for oppositional children. In A.E. Kazdin & J. R. Weisz (Eds.), Evidence-based psychotherapies for children and adolescents (pp. 204-223). New York: Guilford.
- BackgroundForgatch, M. S., & Patterson, G. R. (2010). Parent Management Training -- Oregon Model: An intervention for antisocial behavior in children and adolescents. In J. R. Weisz & A. E. Kazdin (Eds.), Evidence based psychotherapies for children and adolescents (2nd ed., pp. 159-178). New York, NY: Guilford.
- Background: PubMed 20298653Huebner CE, Riedy CA. Behavioral determinants of brushing young children's teeth: implications for anticipatory guidance. Pediatr Dent. 2010 Jan-Feb;32(1):48-55.
- Background: PubMed 18377105Kazdin AE. Evidence-based treatment and practice: new opportunities to bridge clinical research and practice, enhance the knowledge base, and improve patient care. Am Psychol. 2008 Apr;63(3):146-59. doi: 10.1037/0003-066X.63.3.146.
- Background: PubMed 15072477Pine CM, Adair PM, Petersen PE, Douglass C, Burnside G, Nicoll AD, Gillett A, Anderson R, Beighton D, Jin-You B, Broukal Z, Brown JP, Chestnutt IG, Declerck D, Devine D, Espelid I, Falcolini G, Ping FX, Freeman R, Gibbons D, Gugushe T, Harris R, Kirkham J, Lo EC, Marsh P, Maupome G, Naidoo S, Ramos-Gomez F, Sutton BK, Williams S. Developing explanatory models of health inequalities in childhood dental caries. Community Dent Health. 2004 Mar;21(1 Suppl):86-95.
- BackgroundWebster-Stratton, C., & Reid, M. J. (2003). Strengthening social and emotional competence in young children--the foundation for early school readiness and success: Incredible Years Classroom Social Skills and Problem-Solving curriculum. Infants and Young Children, 17(2), 96-113.
- Background: PubMed 15072479Adair PM, Pine CM, Burnside G, Nicoll AD, Gillett A, Anwar S, Broukal Z, Chestnutt IG, Declerck D, Ping FX, Ferro R, Freeman R, Grant-Mills D, Gugushe T, Hunsrisakhun J, Irigoyen-Camacho M, Lo EC, Moola MH, Naidoo S, Nyandindi U, Poulsen VJ, Ramos-Gomez F, Razanamihaja N, Shahid S, Skeie MS, Skur OP, Splieth C, Soo TC, Whelton H, Young DW. Familial and cultural perceptions and beliefs of oral hygiene and dietary practices among ethnically and socio-economicall diverse groups. Community Dent Health. 2004 Mar;21(1 Suppl):102-11.
- Background: PubMed 25070036Huebner CE, Milgrom P. Evaluation of a parent-designed programme to support tooth brushing of infants and young children. Int J Dent Hyg. 2015 Feb;13(1):65-73. doi: 10.1111/idh.12100. Epub 2014 Jul 29.
- BackgroundEdelstein, B. L. (2008). Environmental factors in implementing the dental home for all young children. National Oral Policy Center at Children's Dental Health Project.
- Intervention websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David R Smith, PhD principal investigator
Oregon Research Behavioral Intervention Strategies, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comparison Condition, BeReady2Smile video only and BeReady2Smile video and BeReady2Smile app completely self-guided in people with Plaque, run by Oregon Research Behavioral Intervention Strategies, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in parental attitudes towards child tooth brushing and caries (time frame: T1 (Baseline) and T3 (three month)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05321719, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2025.