Plaque Removal Efficiency in Children With Specific Learning Disabilities
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-12
SponsorAlanya Alaaddin Keykubat University
About this trial
This study aims to evaluate the effectiveness of toothbrushing education on plaque removal in children aged 7-12 years with specific learning disabilities (SLD) and to compare their plaque removal performance with healthy children. Participants will receive standardized toothbrushing education supported by visual and auditory materials. Plaque Index, Gingival Index, and photograph-based quantitative plaque analyses will be evaluated at baseline and after a 2-week follow-up period.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Standardized Toothbrushing Education
BehavioralParticipants 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.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Children With Specific Learning DisabilitiesExperimental treatment 1 intervention
Group B: Healthy Control ChildrenActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in plaque percentage (P%) measured using ImageJ/FIJI analysis
Quantitative plaque percentage changes will be evaluated using disclosed plaque areas obtained from intraoral photographs before and after toothbrushing procedures.
Time frame
Baseline and 2 weeksSecondary outcomes
1
Change in Plaque Index (Silness and Löe Plaque Index) Scores
Plaque accumulation will be assessed using the Silness and Löe Plaque Index. The index ranges from 0 to 3. A score of 0 indicates no plaque. A score of 1 indicates a thin film of plaque adhering to the free gingival margin and adjacent area of the tooth, detectable only by running a probe across the tooth surface. A score of 2 indicates moderate accumulation of soft deposits visible to the naked eye on the tooth surface and gingival margin. A score of 3 indicates abundant soft deposits within the gingival pocket and/or on the tooth and gingival margin. Higher scores indicate poorer oral hygiene and greater plaque accumulation. Changes will be evaluated at baseline and after the 2-week toothbrushing education period.
Time frame
Baseline and 2 weeks2
Change in Gingival Index (Löe and Silness Gingival Index) Scores
Gingival health will be assessed using the Löe and Silness Gingival Index. The index ranges from 0 to 3. A score of 0 indicates healthy gingiva with no signs of inflammation. A score of 1 indicates mild inflammation characterized by slight color change and edema without bleeding on probing. A score of 2 indicates moderate inflammation characterized by redness, edema, and bleeding on probing. A score of 3 indicates severe inflammation characterized by marked redness, edema, ulceration, and a tendency toward spontaneous bleeding. Higher scores indicate poorer gingival health and more severe gingival inflammation. Changes in Gingival Index scores will be evaluated at baseline and after the 2-week toothbrushing education period.
Time frame
Baseline and 2 weeksSponsors and contacts
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Source ClinicalTrials.gov