NCT07492810

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 20, 2021

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 23, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 23, 2025

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 25, 2026

Completed
Last Updated

March 25, 2026

Status Verified

March 1, 2026

Enrollment Period

3.8 years

First QC Date

March 16, 2026

Last Update Submit

March 19, 2026

Conditions

Keywords

Autism Spectrum Disorder (ASD)video modelingpeer video modelingoral health, tooth brushing

Outcome Measures

Primary Outcomes (3)

  • Modified silness-löe plaque ındex (mPLI)

    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)

    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

    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

Study Arms (3)

Peer video modeling

EXPERIMENTAL

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.

Other: Peer video modeling

3D video modeling

EXPERIMENTAL

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.

Other: 3D jaw video modeling

Control group

NO INTERVENTION

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.

Interventions

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.

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 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.

3D video modeling

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Umraniye Community Mental Health Center

Istanbul, Ümraniye, 34760, Turkey (Türkiye)

Location

Related Links

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
The pediatric dentist who conducted the examinations, the special education teacher who assigned the groups, and the statistician were all blind to the study.
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc, PhD, Registered Nurse

Study Record Dates

First Submitted

March 16, 2026

First Posted

March 25, 2026

Study Start

September 20, 2021

Primary Completion

June 23, 2025

Study Completion

June 23, 2025

Last Updated

March 25, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations