Autism DisorderAutism ASDNCT07859696
Effectiveness of Interactive Techniques on Oral Hygiene Skills in a Group of Autistic Egyptian Children
A study testing Peer model, Pre-recorded video of peer modeling and Pedagogical method in people with Autism Disorder and Autism Spectrum Disorder (ASD, run by Faculty of Dental Medicine for Girls.
Trial summary
The present study will be performed to evaluate the effectiveness of peer modeling and audiovisual peer modeling video on toothbrushing skills in comparison to the visual pedagogical method at home. To monitor the improvement of teeth brushing skills in children with ASD using plaque and gingival indices. Read more about this study
- Who is it for?
- Ages 6 to 10 years
- Conditions the study is for
- Autism Disorder, Autism Spectrum Disorder (ASD, Autism
- What is being tested?
- Peer model, Pre-recorded video of peer modeling and Pedagogical method
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Feb 2027to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosed with autism, DSM-5, Asperger syndrome, or Pervasive Developmental Disorder Not Otherwise Specified.
- Understanding visual or simple verbal instructions (Level 1- 2 autism). Parents are willing to participate.
Who cannot join
- Children who have any mental/physical disability will be excluded from the study.
- Adolescents >11 will be excluded to avoid hormonal factors, which could influence results, as hormonal fluctuations mainly impact the gingiva and periodontium, altering tissue response and increasing inflammation susceptibility.
- Parents are unwilling to participate in the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effectiveness of Peer Modeling, Video Modeling, and Visual Pedagogical Techniques on Oral Hygiene Skills in a Group of Autistic Egyptian Children
The present study will be performed to evaluate the effectiveness of peer modeling and audiovisual peer modeling video on toothbrushing skills in comparison to the visual pedagogical method at home. To monitor the improvement of teeth brushing skills in children with ASD using plaque and gingival indices.
- Conditions
- Autism Disorder, Autism Spectrum Disorder (ASD, Autism, Plaque Reduction, Plaque Induced Gingival Disease, Plaque Accumulation
- Being tested
- Peer model, Pre-recorded video of peer modeling, Pedagogical method
- Keywords
- pedagogy, peer modeling, Children with autism, oral hygiene, Plaque index, gingival index
- Medical subject headings
- Autistic Disorder, Autism Spectrum Disorder, Gingival Hemorrhage, Gingivitis, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer modelProcedure or surgery
A child of the same age performing toothbrushing
Pre-recorded video of peer modelingProcedure or surgery
Patients will be subjected to peer video modeling brushing teeth
Pedagogical methodOther
Sequential cards of teeth brushing (visual pedagogy) will be taken home
| Study group | Role | What they receive |
|---|---|---|
| Group I | Active comparator | will receive real peer modeling Receives: Procedure: Peer model |
| Group II | Experimental | will receive audiovisual peer modeling for toothbrushing training Receives: Procedure: Pre-recorded video of peer modeling |
| Group III | Sham comparator | will receive visual pedagogical toothbrushing instructions at home Receives: Other: Pedagogical method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque index
Plaque will be assessed using a mouth mirror and dental probe according to Silness and Löe (PI) (GI) indices
Measured: From enrollment to the end of study at 4 weeks
Modified Gingival Index
Gingival bleeding will be assessed using a mouth mirror and dental probe according to Silness and Löe (PI) (GI) indices criteria as well as the modified gingival index.
Measured: From enrollment to the end of study at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study startFeb 2027 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism DisorderStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Faculty of Dental Medicine for Girls
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Nourhan Kamal Abdrabouh, Faculty of Dental Medicine for Girls
- Investigators
- Aya-Allah Salem Ali, PhD, Study chair, Al-Azhar University Faculty of Dentistry for Girls
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07859696
- Sponsor's protocol ID
- P-PE-26-07
- Acronym
- Autism ASD
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I have to review this issue with my study official first
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Peer Modeling, Video Modeling, and Visual Pedagogical Techniques on Oral Hygiene Skills in a Group of Autistic Egyptian Children
- ClinicalTrials.gov ID
- NCT07859696
- Acronym / sponsor ID
- Autism ASD / P-PE-26-07
- Conditions
- Autism Disorder, Autism Spectrum Disorder (ASD, Autism, Plaque Reduction, Plaque Induced Gingival Disease, Plaque Accumulation
- Keywords
- pedagogy, peer modeling, Children with autism, oral hygiene, Plaque index, gingival index
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Faculty of Dental Medicine for GirlsOther government
- Study start
- Feb 2027 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 6 Oct 2026 (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.
The present study will be performed to evaluate the effectiveness of peer modeling and audiovisual peer modeling video on toothbrushing skills in comparison to the visual pedagogical method at home. To monitor the improvement of teeth brushing skills in children with ASD using plaque and gingival indices.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I | Active comparator | Procedure: Peer modelwill receive real peer modeling |
| Group II | Experimental | Procedure: Pre-recorded video of peer modelingwill receive audiovisual peer modeling for toothbrushing training |
| Group III | Sham comparator | Other: Pedagogical methodwill receive visual pedagogical toothbrushing instructions at home |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Diagnosed with autism, DSM-5, Asperger syndrome, or Pervasive Developmental Disorder Not Otherwise Specified.
- Understanding visual or simple verbal instructions (Level 1- 2 autism). Parents are willing to participate.
Key exclusion criteria (3 listed)
- Children who have any mental/physical disability will be excluded from the study.
- Adolescents >11 will be excluded to avoid hormonal factors, which could influence results, as hormonal fluctuations mainly impact the gingiva and periodontium, altering tissue response and increasing inflammation susceptibility.
- Parents are unwilling to participate in the study.
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 |
|---|---|---|
| Peer modelA child of the same age performing toothbrushing | Procedure or surgery | Group I |
| Pre-recorded video of peer modelingPatients will be subjected to peer video modeling brushing teeth | Procedure or surgery | Group II |
| Pedagogical methodSequential cards of teeth brushing (visual pedagogy) will be taken home | Other | Group III |
Primary outcome
Plaque index
Time frame: From enrollment to the end of study at 4 weeks
Plaque will be assessed using a mouth mirror and dental probe according to Silness and Löe (PI) (GI) indices
Modified Gingival Index
Time frame: From enrollment to the end of study at 4 weeks
Gingival bleeding will be assessed using a mouth mirror and dental probe according to Silness and Löe (PI) (GI) indices criteria as well as the modified gingival index.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: No. I have to review this issue with my study official first
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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.
Aya-Allah Salem Ali, PhD study chair
Al-Azhar University Faculty of Dentistry for Girls
Questions about this trial
What is this clinical trial studying?
A study testing Peer model, Pre-recorded video of peer modeling and Pedagogical method in people with Autism Disorder and Autism Spectrum Disorder (ASD, run by Faculty of Dental Medicine for Girls.
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 2 inclusion and 3 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: opening soon, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nourhan Kamal Abdrabouh, MSc (+201012044354, nourhan.kamal@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plaque index (time frame: From enrollment to the end of study at 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Oct 2026.