- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07611942
Plaque Removal Efficiency in Children With Specific Learning Disabilities (PRE-SLD)
Quantitative Analysis of Plaque Removal Efficiency in Children With Specific Learning Disabilities
Study Overview
Status
Intervention / Treatment
Detailed Description
Dental plaque is one of the major etiological factors associated with oral diseases such as dental caries and gingival inflammation. Effective plaque control through proper toothbrushing habits plays an important role in maintaining oral health in children. However, children with specific learning disabilities (SLD) may experience difficulties in acquiring and maintaining adequate oral hygiene behaviors because of limitations in learning processes, attention, and motor coordination.
The aim of this study is to evaluate the short-term effectiveness of structured toothbrushing education in children aged 7-12 years with SLD and to compare plaque removal performance with healthy children using photograph-based quantitative analysis methods.
The study will be conducted at the Department of Pediatric Dentistry, Faculty of Dentistry, Alanya Alaaddin Keykubat University. Children diagnosed with SLD and age-matched healthy controls will be included in the study. All participants will receive standardized toothbrushing education supported by visual cards and educational videos. Educational materials will be prepared in a child-friendly format and based on the Modified Bass toothbrushing technique.
A plaque-disclosing agent will be applied to all participants to visualize dental plaque before photography. Intraoral photographs will be obtained under standardized conditions using the same lighting, camera settings, and imaging protocol. At each evaluation session, intraoral photographs will be obtained both before and after toothbrushing in order to assess immediate plaque removal effectiveness. Quantitative plaque analysis will be performed using ImageJ/FIJI software by calculating plaque percentage (P%) values from disclosed plaque areas.
Participants will use standardized toothbrushes and toothpaste throughout the study period. During the 2-week follow-up period, children will be encouraged to continue toothbrushing under parental supervision using the taught brushing technique. At follow-up visits, Plaque Index, Gingival Index, plaque disclosure, and intraoral photography procedures will be repeated to evaluate changes in plaque removal effectiveness and oral hygiene performance.
The findings of this study are expected to contribute to the development of individualized oral hygiene education approaches for children with specific learning disabilities and to support the use of photograph-based quantitative plaque analysis methods in pediatric dentistry research.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: gül keskin, Associate Professor, DDS, PhD
- Phone Number: +905444468857
- Email: gul.keskin@alanya.edu.tr
Study Locations
-
-
Antalya
-
Alanya, Antalya, Turkey (Türkiye), 07400
- Alanya Alaaddin Keykubat University Faculty of Dentistry
-
Contact:
- Gül Keskin, Associate Professor, DDS, PhD
- Phone Number: +90 242 510 61 40
- Email: gul.keskin@alanya.edu.tr
-
Contact:
- Fatma Yaman Toktasır, Research Assistant, DDS
- Phone Number: +905055881265
- Email: yamanfatma07@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Diagnosis of specific learning disabilities confirmed by a child and adolescent psychiatry specialist for the study group Confirmation by a child and adolescent psychiatry specialist that the control group participants are healthy and do not have any psychiatric diagnosis Age between 7 and 12 years Written informed consent obtained from parents or legal guardians
Exclusion Criteria:
- Children with additional psychiatric diagnoses such as autism spectrum disorder, attention deficit/hyperactivity disorder, or intellectual disability Children with systemic health problems or physical disabilities that may interfere with participation in the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Children With Specific Learning Disabilities
Children with specific learning disabilities receiving standardized toothbrushing education.
|
Participants will receive standardized toothbrushing education supported by visual educational cards and educational videos based on the Modified Bass toothbrushing technique.
The education program will include step-by-step practical instruction, mirror-assisted self-modeling, and parental involvement.
Standardized toothbrushes and toothpaste will be provided to all participants.
Plaque removal effectiveness will be evaluated using plaque-disclosing agents, intraoral photographs obtained before and after toothbrushing, and quantitative plaque analysis performed with ImageJ/FIJI software.
|
|
Active Comparator: Healthy Control Children
Healthy children receiving standardized toothbrushing education.
|
Participants will receive standardized toothbrushing education supported by visual educational cards and educational videos based on the Modified Bass toothbrushing technique.
The education program will include step-by-step practical instruction, mirror-assisted self-modeling, and parental involvement.
Standardized toothbrushes and toothpaste will be provided to all participants.
Plaque removal effectiveness will be evaluated using plaque-disclosing agents, intraoral photographs obtained before and after toothbrushing, and quantitative plaque analysis performed with ImageJ/FIJI software.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in plaque percentage (P%) measured using ImageJ/FIJI analysis
Time Frame: Baseline and 2 weeks
|
Quantitative plaque percentage changes will be evaluated using disclosed plaque areas obtained from intraoral photographs before and after toothbrushing procedures.
|
Baseline and 2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Plaque Index scores
Time Frame: Baseline and 2 weeks
|
Changes in Plaque Index scores will be evaluated before toothbrushing education and after the 2-week follow-up period.
|
Baseline and 2 weeks
|
|
Change in Gingival Index scores
Time Frame: Baseline and 2 weeks
|
Changes in Gingival Index scores will be evaluated before toothbrushing education and after the 2-week follow-up period.
|
Baseline and 2 weeks
|
Collaborators and Investigators
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ALKU-PEDO-2025-10/1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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