- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07492810
The Effect of Peer Video Modeling and 3D Jaw Video Modeling Training on Oral Health and Toothbrushing Skills in Children With Autism (RCT)
This study was conducted to improve the oral hygiene habits of children with Autism Spectrum Disorder (ASD) and to compare the effects of peer video modeling and three-dimensional (3D) jaw model simulation methods. The research was carried out at Istanbul Hamit Ibrahimiye Special Education Practice School with a randomized controlled experimental design, involving 120 children aged 6-12 years. The participants were divided into three groups: peer video modeling, 3D jaw model simulation, and control. Data collection tools included a sociodemographic information form, oral and dental health knowledge form, plaque index, gingival index and tooth brushing evaluation forms. The study was evaluated based on assessments conducted at baseline, 1st month, 3rd month, and 6th month.
The findings of the study revealed that the peer video modeling method significantly reduced the plaque index (p < 0.05) and led to a notable improvement in tooth brushing skills. The improvement observed in the 3D jaw model simulation group was more limited. In terms of long-term effects, peer video modeling was found to have a lasting impact on children's oral hygiene habits (p < 0.01). These results indicate that peer video modeling is particularly more effective in promoting tooth brushing habits among children with ASD.
In conclusion, peer video modeling appears to be a more effective method for oral and dental health education in children with ASD. Future studies should examine its long-term effects in more detail across different age groups. In addition, developing guideline materials for parents and educators may be beneficial.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ümraniye
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Istanbul, Ümraniye, Turkey (Türkiye), 34760
- Umraniye Community Mental Health Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- The child responds to their name when called.
- The child maintains eye contact for at least 2-5 minutes.
- The child follows simple instructions (e.g., come, sit, open-close mouth).
- The child can use at. least one reward (food, toy, or verbal).
- No sensory hypersensitivity.
- No antibiotic use in the last month.
- No additional plaque control application in the last 5 months.
- At least 20 teeth present.
- Not undergoing orthodontic treatment.
- No systemic diseases affecting oral health (e.g., Down syndrome, diabetes).
- Average intelligence level comparable to peers.
- Able to brush teeth independently.
Exclusion Criteria:
- Inability to sit in a specific place for 10 minutes.
- Refusal of physical contact (mouth, face, body).
- Severe autism (Grade 3).
- Mental retardation.
- Lack of parental consent.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Peer video modeling
After obtaining written parental consent and demographic data, the study protocol is implemented.
Oral examinations are conducted in the school infirmary by a pediatric dentist, under the researcher's supervision, using disposable materials.
The number of teeth, caries and fillings, plaque index scores, and gingival health are recorded.
Children and their parents then watch a 14-step toothbrushing instructional video in a separate classroom, in which a healthy 12-year-old boy demonstrates proper brushing behaviors with verbal instructions.
Following the video, children practice brushing using a mirror and materials provided by the researcher.
Performance is assessed using a 14-step tool scored from 0 to 3, and parents receive individualized feedback.
For the peer video modeling group, a WhatsApp group is created, and parents are instructed to show the video daily before brushing.
Assessments are conducted at baseline and at 1, 3, and 6 months using plaque and gingival indices.
|
After obtaining written parental consent and demographic data, the study protocol is implemented.
Oral examinations are conducted in the school infirmary by a pediatric dentist, under the researcher's supervision, using disposable materials.
The number of teeth, caries and fillings, plaque index scores, and gingival health are recorded.
Children and their parents then watch a 14-step toothbrushing instructional video in a separate classroom, in which a healthy 12-year-old boy demonstrates proper brushing behaviors with verbal instructions.
Following the video, children practice brushing using a mirror and materials provided by the researcher.
Performance is assessed using a 14-step tool scored from 0 to 3, and parents receive individualized feedback.
For the peer video modeling group, a WhatsApp group is created, and parents are instructed to show the video daily before brushing.
Assessments are conducted at baseline and at 1, 3, and 6 months using plaque and gingival indices.
|
|
Experimental: 3D video modeling
After obtaining written parental consent and demographic data, the study protocol is implemented.
Oral examinations are conducted in the school infirmary by a pediatric dentist under researcher supervision using disposable materials.
The number of teeth, caries and fillings, plaque index scores, and gingival health are recorded.
Children and their parents then watch a 14-step toothbrushing instructional video in a separate classroom, in which a 3D jaw model demonstrates proper brushing behaviors with verbal instructions.
Following the video, children practice brushing using a mirror and materials provided by the researcher.
Performance is assessed using a 14-step tool scored from 0 to 3, and parents receive individualized feedback.
For the peer video modeling group, a WhatsApp group is created, and parents are instructed to show the video daily before brushing.
Assessments are conducted at baseline and at 1, 3, and 6 months using plaque and gingival indices.
|
After obtaining written parental consent and demographic data, the study protocol is implemented.
Oral examinations are conducted in the school infirmary by a pediatric dentist under researcher supervision using disposable materials.
The number of teeth, caries and fillings, plaque index scores, and gingival health are recorded.
Children and their parents then watch a 14-step toothbrushing instructional video in a separate classroom, in which a 3D jaw model demonstrates proper brushing behaviors with verbal instructions.
Following the video, children practice brushing using a mirror and materials provided by the researcher.
Performance is assessed using a 14-step tool scored from 0 to 3, and parents receive individualized feedback.
For the peer video modeling group, a WhatsApp group is created, and parents are instructed to show the video daily before brushing.
Assessments are conducted at baseline and at 1, 3, and 6 months using plaque and gingival indices.
|
|
No Intervention: Control group
After obtaining written parental consent and demographic information, the study protocol is initiated.
Oral examinations are conducted at the school infirmary by a pediatric dentist under researcher supervision using disposable materials.
During the examination, the number of teeth, caries and fillings, plaque index scores, and gingival health are systematically recorded.
Children in the control group receive no intervention during the study period.
Oral health assessments, including plaque index, gingival health, and toothbrushing performance, are conducted at predetermined time points (baseline, 1st, 3rd, and 6th months).
At the end of the six-month study, children and their parents who have not received prior training are provided with toothbrushing education.
The researcher demonstrates proper brushing techniques using a 3D jaw model in the school conference hall, and a peer video modeling material is sent to parents via e-mail or WhatsApp.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Modified silness-löe plaque ındex (mPLI)
Time Frame: Baseline, 1.,3., and 6. months
|
Dental plaque accumulation was assessed using the Modified Silness-Löe Plaque Index (mPLI), a widely used tool for evaluating plaque presence on tooth surfaces, particularly suitable for pediatric and special needs populations.
In accordance with the FDI tooth numbering system and expert consultation, six index teeth (3 buccal, 8 buccal, 14 buccal, 19 lingual, 24 buccal, and 30 lingual) were selected.
Both buccal and lingual surfaces were examined.
Each surface was scored on a 4-point scale (0 = no plaque; 1 = plaque detectable by probe; 2 = visible plaque; 3 = abundant plaque).
The individual plaque score was calculated by dividing the total score by the number of surfaces examined.
Scores were categorized as no (<0.1),
mild (0.1-1.0), moderate (1.1-2.0), or severe (2.1-3.0)
plaque accumulation.
|
Baseline, 1.,3., and 6. months
|
|
Gingival Index (GI)
Time Frame: Baseline, 1., 3., and 6. months
|
Gingival health was assessed using the Silness-Löe Gingival Index, a validated tool used to evaluate gingival inflammation and overall periodontal health.
Gingival inflammation was measured by gently probing four gingival surfaces of each selected tooth with a WHO periodontal probe, applying a force not exceeding 20 g.
Each surface was scored on a 4-point scale (0-3).
The individual gingival index score was calculated by dividing the total score by the number of surfaces examined.
Scores were classified as no (<0.1),
mild (0.1-1.0), moderate (1.1-2.0), or severe (2.1-3.0)
inflammation.
|
Baseline, 1., 3., and 6. months
|
|
Toothbrushing assessment form
Time Frame: Baseline, 1., 3., and 6.months
|
Toothbrushing performance was assessed using a structured 14-step protocol designed to evaluate toothbrushing skills and independence in oral hygiene practices, based on national guidelines and relevant literature.
Each step was scored on a 4-point scale (0 = not completed, 1 = completed with caregiver assistance, 2 = completed with verbal guidance, 3 = completed independently).
The overall score was calculated by dividing the total score by 14.
The protocol includes essential brushing steps, such as cleaning anterior teeth and right and left posterior teeth in both jaws.
This tool enables the systematic assessment of brushing accuracy, skill acquisition, and level of independence in children.
|
Baseline, 1., 3., and 6.months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Bezmialem Vakıf Uni, 25836
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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