NCT05697432

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 14, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 25, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

January 25, 2023

Status Verified

January 1, 2023

Enrollment Period

1 year

First QC Date

January 14, 2023

Last Update Submit

January 14, 2023

Conditions

Oral Hygiene

Keywords

Disabled ChildrenOral HygieneStreptococcus mutans

Outcome Measures

Primary Outcomes (3)

  • Change from baseline in Saliva Check mutans test at 52 weeks

    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

    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

    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

Study Arms (1)

Education

EXPERIMENTAL

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 ExaminationDiagnostic Test: PUFA indexDiagnostic Test: Plaque indexDiagnostic Test: Streptococcus mutans screeningBehavioral: Education

Interventions

Oral ExaminationDIAGNOSTIC_TEST

A complete examination of oral and dental hygiene any health problems will be registered

Education
PUFA indexDIAGNOSTIC_TEST

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

Also known as: Pulpal involvement, ulceration, fistula, abscess index
Education
Plaque indexDIAGNOSTIC_TEST

An assessment of the amount of dental plaque visible on the vestibular and lingual surfaces of all teeth. The index varies between 0-4.

Also known as: Sillness Löe PI
Education
Streptococcus mutans screeningDIAGNOSTIC_TEST

A strip test for specific bacteria named streptococcus mutans, which plays an important role in caries formation, from patients' collected saliva

Also known as: Saliva-check mutans
Education
EducationBEHAVIORAL

Education on correct toothbrushing technique, oral hygiene, dietary education on foods detrimental for dental hygiene.

Education

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Maviel Rehabilitation Center

Kilis, Turkey (Türkiye)

RECRUITING

Sirinler Rehabilitation Center

Kilis, Turkey (Türkiye)

RECRUITING

Ugurlu Kalpler Rehabilitation Center

Kilis, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Physical ExaminationEducational Status

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosisSocioeconomic FactorsPopulation Characteristics

Study Officials

  • Mine Tirnaksiz

    Altinbas University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mine Tirnaksiz

CONTACT

+905069528420dtminetirnaksiz@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 14, 2023

First Posted

January 25, 2023

Study Start

November 1, 2022

Primary Completion

November 1, 2023

Study Completion

November 1, 2023

Last Updated

January 25, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(3)