Orodental Hygiene in Children With Special Needs

January 14, 2023 updated by: Mine Tirnaksiz, Altinbas University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

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

Study Locations

  • Turkey
      • Kilis, Turkey
        • Recruiting
        • Maviel Rehabilitation Center
        • Contact:
      • Kilis, Turkey
        • Recruiting
        • Sirinler Rehabilitation Center
        • Contact:
      • Kilis, Turkey
        • Recruiting
        • Ugurlu Kalpler Rehabilitation Center
        • Contact:

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

6 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

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

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Education
The children with special needs will receive a complete oral examination and then their parent/guardian will be subjected to education about oral hygiene, brushing and dietary guidance.
Diagnostic test: Oral Examination
A complete examination of oral and dental hygiene any health problems will be registered
Diagnostic test: PUFA index
An assessment of the presence of oral conditions resulting from untreated caries. P=Pulpal involvement, U=ulceration, F=fistula, A=abscess index
Other Names:
  • Pulpal involvement, ulceration, fistula, abscess index
Diagnostic test: Plaque index
An assessment of the amount of dental plaque visible on the vestibular and lingual surfaces of all teeth. The index varies between 0-4.
Other Names:
  • Sillness Löe PI
Diagnostic test: Streptococcus mutans screening
A strip test for specific bacteria named streptococcus mutans, which plays an important role in caries formation, from patients' collected saliva
Other Names:
  • Saliva-check mutans
Behavioral: Education
Education on correct toothbrushing technique, oral hygiene, dietary education on foods detrimental for dental hygiene.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 1 year after the education
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.
Baseline and 1 year after the education
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)
Baseline and 1 year after the education

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Altinbas University

Investigators

  • Principal Investigator: Mine Tirnaksiz, Altinbas University

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 (Actual)

November 1, 2022

Primary Completion (Anticipated)

November 1, 2023

Study Completion (Anticipated)

November 1, 2023

Study Registration Dates

First Submitted

January 14, 2023

First Submitted That Met QC Criteria

January 14, 2023

First Posted (Actual)

January 25, 2023

Study Record Updates

Last Update Posted (Actual)

January 25, 2023

Last Update Submitted That Met QC Criteria

January 14, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 81

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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