Specific Learning DisabilitiesPRE-SLDNCT07611942
Plaque Removal Efficiency in Children With Specific Learning Disabilities
A study testing Standardized Toothbrushing Education in people with Specific Learning Disabilities and Dental Plaque, run by Alanya Alaaddin Keykubat University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Specific Learning Disabilities, Dental Plaque, Oral Hygiene
- What is being tested?
- Standardized Toothbrushing Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2026to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Alanya Alaaddin Keykubat University Faculty of Dentistry
Alanya, Antalya, 07400
Gül Keskin, Associate Professor, DDS, PhD, +90 242 510 61 40, gul.keskin@alanya.edu.tr
Fatma Yaman Toktasır, Research Assistant, DDS, +905055881265, yamanfatma07@gmail.com
About this study
Official title: Quantitative Analysis of Plaque Removal Efficiency in Children With Specific Learning Disabilities
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.
- Conditions
- Specific Learning Disabilities, Dental Plaque, Oral Hygiene
- Being tested
- Standardized Toothbrushing Education
- Keywords
- Specific Learning Disabilities, Dental Plaque, Plaque Removal, Quantitative Plaque Analysis, Toothbrushing Education, ImageJ/FIJI, Pediatric Dentistry
- Medical subject headings
- Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized Toothbrushing EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Children With Specific Learning Disabilities | Experimental | Children with specific learning disabilities receiving standardized toothbrushing education. Receives: Behavioral: Standardized Toothbrushing Education |
| Healthy Control Children | Active comparator | Healthy children receiving standardized toothbrushing education. Receives: Behavioral: Standardized Toothbrushing Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 2 weeks
Secondary outcomes (2)
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.
Measured: Baseline and 2 weeks
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.
Measured: Baseline and 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study start15 Jun 2026
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Specific Learning DisabilitiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alanya Alaaddin Keykubat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gül Keskin, Alanya Alaaddin Keykubat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07611942
- Sponsor's protocol ID
- ALKU-PEDO-2025-10/1
- Acronym
- PRE-SLD
- Status last verified
- Jun 2026
- First submitted
- 21 May 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to participant confidentiality and privacy considerations.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Analysis of Plaque Removal Efficiency in Children With Specific Learning Disabilities
- ClinicalTrials.gov ID
- NCT07611942
- Acronym / sponsor ID
- PRE-SLD / ALKU-PEDO-2025-10/1
- Conditions
- Specific Learning Disabilities, Dental Plaque, Oral Hygiene
- Keywords
- Specific Learning Disabilities, Dental Plaque, Plaque Removal, Quantitative Plaque Analysis, Toothbrushing Education, ImageJ/FIJI, Pediatric Dentistry
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Alanya Alaaddin Keykubat UniversityUniversity, hospital or other
- Study start
- 15 Jun 2026 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 28 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children With Specific Learning Disabilities | Experimental | Behavioral: Standardized Toothbrushing EducationChildren with specific learning disabilities receiving standardized toothbrushing education. |
| Healthy Control Children | Active comparator | Behavioral: Standardized Toothbrushing EducationHealthy children receiving standardized toothbrushing education. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardized Toothbrushing EducationParticipants 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. | Behavioural | Children With Specific Learning Disabilities, Healthy Control Children |
Primary outcome
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.
2 secondary outcomes
Change in Plaque Index (Silness and Löe Plaque Index) Scores
Time frame: Baseline and 2 weeks
Change in Gingival Index (Löe and Silness Gingival Index) Scores
Time frame: Baseline and 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to participant confidentiality and privacy considerations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized Toothbrushing Education in people with Specific Learning Disabilities and Dental Plaque, run by Alanya Alaaddin Keykubat University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact gül keskin, Associate Professor, DDS, PhD (+905444468857, gul.keskin@alanya.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in plaque percentage (P%) measured using ImageJ/FIJI analysis (time frame: Baseline and 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.