- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07859696
Effectiveness of Interactive Techniques on Oral Hygiene Skills in a Group of Autistic Egyptian Children (Autism ASD)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nourhan Kamal Abdrabouh, MSc
- Phone Number: +201012044354
- Email: nourhan.kamal@dentistry.cu.edu.eg
Study Contact Backup
- Name: Aya-Allah Salem Ali, PhD
- Phone Number: +20 12 74067604
- Email: ayasalem.26@azhar.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group I
will receive real peer modeling |
A child of the same age performing toothbrushing |
|
Experimental: Group II
will receive audiovisual peer modeling for toothbrushing training |
Patients will be subjected to peer video modeling brushing teeth |
|
Sham Comparator: Group III
will receive visual pedagogical toothbrushing instructions at home |
Sequential cards of teeth brushing (visual pedagogy) will be taken home |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 |
From enrollment to the end of study at 4 weeks
|
|
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. |
From enrollment to the end of study at 4 weeks
|
Collaborators and Investigators
Investigators
- Study Chair: Aya-Allah Salem Ali, PhD, Al-Azhar University Faculty of Dentistry for Girls
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Additional Relevant MeSH Terms
- Periodontal Diseases
- Mouth Diseases
- Stomatognathic Diseases
- Mental Disorders
- Pathologic Processes
- Infections
- Gingival Diseases
- Neurodevelopmental Disorders
- Child Development Disorders, Pervasive
- Oral Hemorrhage
- Pathological Conditions, Signs and Symptoms
- Autism Spectrum Disorder
- Autistic Disorder
- Hemorrhage
- Gingivitis
- Gingival Hemorrhage
Other Study ID Numbers
- P-PE-26-07
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
I have to review this issue with my study official first
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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