Orodental Hygiene in Children With Special Needs

Oral Hygiene Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05697432
• Other study ID #: 81
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: November 1, 2023

Study information

• Verified date: January 2023
• Source: Altinbas University
• Contact: Mine Tirnaksiz
• Phone: +905069528420
• Email: dtminetirnaksiz[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: November 1, 2023
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Oral Hygiene

Intervention

Diagnostic Test:
• Oral Examination
A complete examination of oral and dental hygiene any health problems will be registered
• PUFA index
An assessment of the presence of oral conditions resulting from untreated caries. P=Pulpal involvement, U=ulceration, F=fistula, A=abscess index
• 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.
• Streptococcus mutans screening
A strip test for specific bacteria named streptococcus mutans, which plays an important role in caries formation, from patients' collected saliva

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

Locations

Country	Name	City	State
Turkey	Maviel Rehabilitation Center	Kilis
Turkey	Sirinler Rehabilitation Center	Kilis
Turkey	Ugurlu Kalpler Rehabilitation Center	Kilis

Sponsors (1)

Lead Sponsor	Collaborator
Altinbas University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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