NCT07611981

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
2mo left

Started Jun 2026

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress45%
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 CariesOral Healthdmft/DMFTPediatric DentistryPlaque IndexGingival Index

Outcome Measures

Primary Outcomes (2)

  • Dental Caries Experience (dmft/DMFT)

    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)

    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 Outcomes (2)

  • Plaque Index (PI)

    Single assessment at the time of clinical examination

  • Gingival Index (GI)

    Single assessment at the time of clinical examination

Study Arms (2)

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.

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

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 Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Central Study Contacts

Gül Keskin, Associate Professor, DDS, PhD

CONTACT

Fatma Yaman Toktasır, Research Assistant, DDS

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
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