Orodental Hygiene in Children With Special Needs

Not Applicable

Recruiting

• Conditions: Oral Hygiene
• Interventions: Diagnostic Test: Oral Examination; Diagnostic Test: PUFA index; Diagnostic Test: Plaque index; Diagnostic Test: Streptococcus mutans screening; Behavioral: Education

• Registration Number: NCT05697432
• Lead Sponsor: Altinbas University

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.

Study Timeline

• Study Start: 2022-11-01
• Status Verified: 2023-01
• Study First Submitted: 2023-01-14
• Study First Submitted QC: 2023-01-14
• Last Update Submitted: 2023-01-14
• Study First Posted: 2023-01-25
• Last Update Posted: 2023-01-25
• Primary Completion: 2023-11-01
• Study Completion: 2023-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Education	Oral Examination	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.
Education	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.
Education	PUFA index	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.
Education	Plaque index	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.
Education	Streptococcus mutans screening	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.

Primary Outcome Measures

Name	Time	Method
Change from baseline in Saliva Check mutans test at 52 weeks	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	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	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.

Trial Locations

Locations (3)

Sirinler Rehabilitation Center; 🇹🇷 Kilis, Turkey

Ugurlu Kalpler Rehabilitation Center; 🇹🇷 Kilis, Turkey

Maviel Rehabilitation Center; 🇹🇷 Kilis, Turkey