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Clinical Trials/NCT05697432
NCT05697432
Recruiting
Not Applicable

Evaluation of Oral and Dental Hygiene in Individuals With Special Needs Between 6 to 12 Years of Age

Altinbas University3 sites in 1 country150 target enrollmentNovember 1, 2022
ConditionsOral Hygiene

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Oral Hygiene
Sponsor
Altinbas University
Enrollment
150
Locations
3
Primary Endpoint
Change from baseline in Saliva Check mutans test at 52 weeks
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

This clinical trial aims to learn about the general oral hygiene status of children with special needs and test the effect of hygiene education on their oral and dental hygiene. The main questions it aims to answer are:

  • What is the general oral hygiene status of children with special needs?
  • Does brushing education and dietary guidance to parents improve oral and dental hygiene in children with special needs? Participants will receive a complete oral and dental examination. Following this examination parents/legal guardians will be educated about the maintenance of oral and dental hygiene and dietary guidance will be provided. Patients will be evaluated one year after the education

Detailed Description

One hundred and thirty children with special needs who are being rehabilitated at three rehabilitation centers (Maviel, Sirinler and Ugurlu Kalpler Rehabilitation Centers) in Kilis will undergo a complete oral and dental examination at which their oral bacteria (str. mutans) levels, PUFA and plaque indexes (indices that measure oral health) will be recorded. The parents/legal guardians of the children will be educated about dental hygiene toothbrushing and dietary habits leading to caries. After a year, the examination and assessments will be repeated. The change in oral hygiene indices will be evaluated.

Registry
clinicaltrials.gov
Start Date
November 1, 2022
End Date
November 1, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Altinbas University
Responsible Party
Principal Investigator
Principal Investigator

Mine Tirnaksiz

Principal Investigator

Altinbas University

Eligibility Criteria

Inclusion Criteria

  • Children with special needs
  • Aged between 6-12 years

Exclusion Criteria

  • Being unable to complete oral examination due to lack of cooperation

Outcomes

Primary Outcomes

Change from baseline in Saliva Check mutans test at 52 weeks

Time Frame: Baseline and 1 year after the education

A speed test of specific bacteria named streptococcus mutans, which plays a leading role in caries formation, from patients' collected saliva. Interpreted from the strips as high, low levels of bacteria or no bacteria in saliva.

Change from baseline on the 5 point plaque index at 52 weeks

Time Frame: Baseline and 1 year after the education

An assessment of the amount of dental plaque visible on the vestibular and lingual surfaces of all teeth. Possible scores range from 0 (no plaque) to 4 (considerable plaque film formation)

Change from baseline in the number of teeth with each element of PUFA index at 52 weeks

Time Frame: Baseline and 1 year after the education

An assessment of the presence of oral conditions resulting from untreated caries. P=Pulpal involvement, U=ulceration, F=fistula, A=abscess index.

Study Sites (3)

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