NCT07611942

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
2mo left

Started Jun 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress44%
Jun 2026Oct 2026

First Submitted

Initial submission to the registry

May 21, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 28, 2026

Completed
18 days until next milestone

Study Start

First participant enrolled

June 15, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

June 16, 2026

Status Verified

June 1, 2026

Enrollment Period

4 months

First QC Date

May 21, 2026

Last Update Submit

June 15, 2026

Conditions

Keywords

Specific Learning DisabilitiesDental PlaquePlaque RemovalQuantitative Plaque AnalysisToothbrushing EducationImageJ/FIJIPediatric Dentistry

Outcome Measures

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.

    Baseline and 2 weeks

Secondary Outcomes (2)

  • Change in Plaque Index (Silness and Löe Plaque Index) Scores

    Baseline and 2 weeks

  • Change in Gingival Index (Löe and Silness Gingival Index) Scores

    Baseline and 2 weeks

Study Arms (2)

Children With Specific Learning Disabilities

EXPERIMENTAL

Children with specific learning disabilities receiving standardized toothbrushing education.

Behavioral: Standardized Toothbrushing Education

Healthy Control Children

ACTIVE COMPARATOR

Healthy children receiving standardized toothbrushing education.

Behavioral: Standardized Toothbrushing Education

Interventions

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.

Children With Specific Learning DisabilitiesHealthy Control Children

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alanya Alaaddin Keykubat University Faculty of Dentistry

Alanya, Antalya, 07400, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Dental Plaque

Condition Hierarchy (Ancestors)

Dental DepositsTooth DiseasesStomatognathic Diseases

Central Study Contacts

gül keskin, Associate Professor, DDS, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcome assessor performing the quantitative plaque analysis will be blinded to group allocation.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, DDS, PhD

Study Record Dates

First Submitted

May 21, 2026

First Posted

May 28, 2026

Study Start

June 15, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

June 16, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared due to participant confidentiality and privacy considerations.

Locations