- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07611981
Dental Caries and Oral Hygiene Status in Children With Specific Learning Disabilities (SLD-OH)
May 21, 2026 updated by: Gül Keskin, Alanya Alaaddin Keykubat University
This study aims to evaluate dental caries and oral hygiene status in children aged 7-12 years with specific learning disabilities (SLD) and to compare the findings with healthy children.
Clinical oral examinations, including dmft/DMFT, ICDAS II, Plaque Index, and Gingival Index assessments, will be performed.
In addition, questionnaire-based evaluations of oral hygiene habits, dietary habits, and parental supervision during toothbrushing will be conducted.
Study Overview
Status
Not yet recruiting
Study Type
Observational
Enrollment (Estimated)
70
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Gül Keskin, Associate Professor, DDS, PhD
- Phone Number: +90 242 510 61 40
- Email: gul.keskin@alanya.edu.tr
Study Contact Backup
- Name: Fatma Yaman Toktasır, Research Assistant, DDS
- Phone Number: +905055881265
- Email: yamanfatma07@gmail.com
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 6140
- Email: gul.keskin@alanya.edu.tr
-
Contact:
- Fatma Yaman Toktasır, Research assistant,DDS
- Phone Number: +90 5055881265
- Email: yamanfatma07@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Children aged 7-12 years presenting to Alanya Alaaddin Keykubat University Faculty of Dentistry Paediatric Dentistry Clinic.
The study group consists of children diagnosed with specific learning disorder (SLD) by a psychiatrist.
The control group consists of healthy children with no psychiatric diagnosis, confirmed by a psychiatrist.
Description
Inclusion Criteria:
- Children aged 7-12 years
- For the study group: diagnosis of specific learning disorder (SLD) confirmed by a psychiatrist
- For the control group: confirmed healthy with no psychiatric diagnosis by a psychiatrist
- Written informed consent obtained from the parent or guardian
Exclusion Criteria:
- Children with additional psychiatric diagnoses (e.g., autism spectrum disorder, attention-deficit/hyperactivity disorder, intellectual disability)
- Children with systemic disease or physical disability that may prevent participation in the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Children with Specific Learning Disorder (SLD)
Children aged 7-12 years diagnosed with specific learning disorder by a psychiatrist, presenting to Alanya Alaaddin Keykubat University Faculty of Dentistry.
Dental caries experience (dmft/DMFT), caries severity (ICDAS II), plaque index and gingival index will be assessed.
|
|
Healthy Control Children
Children aged 7-12 years with no psychiatric diagnosis, confirmed healthy by a psychiatrist, presenting to Alanya Alaaddin Keykubat University Faculty of Dentistry Paediatric Dentistry Clinic.
Dental caries experience (dmft/DMFT), caries severity (ICDAS II), plaque index and gingival index will be assessed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dental Caries Experience (dmft/DMFT)
Time Frame: Single assessment at the time of clinical examination
|
Decayed, missing, and filled teeth index for primary (dmft) and permanent (DMFT) dentition, assessed according to WHO criteria using mirror and periodontal probe under dental unit light.
|
Single assessment at the time of clinical examination
|
|
Caries Severity (ICDAS II)
Time Frame: Single assessment at the time of clinical examination
|
International Caries Detection and Assessment System II score recorded for each tooth using visual and tactile examination.
The highest ICDAS II code recorded for each patient is used as the individual score.
|
Single assessment at the time of clinical examination
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Plaque Index (PI)
Time Frame: Single assessment at the time of clinical examination
|
Loe & Silness Plaque Index assessing dental plaque thickness at the gingival margin, scored 0-3.
|
Single assessment at the time of clinical examination
|
|
Gingival Index (GI)
Time Frame: Single assessment at the time of clinical examination
|
Loe & Silness Gingival Index assessing quality, severity and localisation of gingival disease, scored 0-3.
|
Single assessment at the time of clinical examination
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
June 1, 2026
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
October 1, 2026
Study Registration Dates
First Submitted
May 21, 2026
First Submitted That Met QC Criteria
May 21, 2026
First Posted (Actual)
May 28, 2026
Study Record Updates
Last Update Posted (Actual)
May 28, 2026
Last Update Submitted That Met QC Criteria
May 21, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ALKU-PEDO-2026-12/2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Individual participant data (IPD) will not be shared due to participant confidentiality and privacy considerations.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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