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RecruitingNCT07611942PRE-SLDUpdated Jun 16, 2026

Plaque Removal Efficiency in Children With Specific Learning Disabilities

An interventional study of Standardized Toothbrushing Education in Specific Learning Disabilities, Dental Plaque and Oral Hygiene, sponsored by Alanya Alaaddin Keykubat University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 7 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-16.

Sponsored by Alanya Alaaddin Keykubat University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Started Jun 2026; still recruiting 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Non-randomized
Ages
7 Years to 12 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Specific Learning Disabilities
  • Dental Plaque
  • Oral Hygiene

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Keywords

  • Specific Learning Disabilities
  • Dental Plaque
  • Plaque Removal
  • Quantitative Plaque Analysis
  • Toothbrushing Education
  • ImageJ/FIJI
  • Pediatric Dentistry
03

In context

Dental Plaque

352 studies on the registry are indexed under Dental Plaque; 60 are open to participants now.

This study's planned enrollment of 70 is above the median of 56 across 316 interventional studies indexed under Dental Plaque.

Browse Dental Plaque studies →

Lead sponsor

Alanya Alaaddin Keykubat University is the lead sponsor of 51 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 obtained from parents or legal guardians

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
70 participants (estimated)

Study arms

  • Experimental
    Children With Specific Learning Disabilities

    Children with specific learning disabilities receiving standardized toothbrushing education.

    Behavioral: Standardized Toothbrushing Education

  • Active comparator
    Healthy Control Children

    Healthy children receiving standardized toothbrushing education.

    Behavioral: Standardized Toothbrushing Education

Interventions

  • BehavioralStandardized 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.

06

What researchers measure

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 weeks

Secondary 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 weeks

  2. 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 weeks

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No — Individual participant data (IPD) will not be shared due to participant confidentiality and privacy considerations.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2026 (actual). Primary completion is estimated for Oct 2026, 4 months after the start.

Of 133 non-industry interventional studies with no phase under Dental Plaque, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 16. This study's planned 4 months is below that.

Counting every sponsor, half of 178 studies reached it within 6 months; a quarter within 2 and three quarters within 14.

How these figures are worked out, and which studies are left out of them.

Registered
May 21, 2026
First posted
May 28, 2026
StartActual
Jun 15, 2026
Primary completionEst.
Oct 2026
CompletionEst.
Oct 2026
Last update
Jun 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07611942
Lead sponsor
Alanya Alaaddin Keykubat University
Responsible party
Gül Keskin (Associate Professor, DDS, PhD, Alanya Alaaddin Keykubat University) — Principal investigator
First posted
May 28, 2026
Start date
Jun 15, 2026
Primary completion
Oct 2026 (estimated)
Completion
Oct 2026 (estimated)
Last update
Jun 16, 2026

Study contacts

gül keskin, Associate Professor, DDS, PhD
Contact
gul.keskin@alanya.edu.tr
+905444468857

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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