Orodental Hygiene in Children With Special Needs

• Sponsor: Altinbas University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05697432
• Collaborator: (none)
• Enrollment: 150
• Locations: 3
• Arm: 1
• Anticipated Duration (Months): 12
• Patients Per Site: 50
• Patients Per Site Per Month: 4.2

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Oral Hygiene	Diagnostic Test: Oral Examination; Diagnostic Test: PUFA index; Diagnostic Test: Plaque index; Diagnostic Test: Streptococcus mutans screening; Behavioral: Education	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 150 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Evaluation of Oral and Dental Hygiene in Individuals With Special Needs Between 6 to 12 Years of Age
• Actual Study Start Date: Nov 1, 2022
• Anticipated Primary Completion Date: Nov 1, 2023
• Anticipated Study Completion Date: Nov 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

3. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 12 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maviel Rehabilitation Center	Kilis		Turkey
2	Sirinler Rehabilitation Center	Kilis		Turkey
3	Ugurlu Kalpler Rehabilitation Center	Kilis		Turkey

Sponsors and Collaborators

• Altinbas University

Investigators

• Principal Investigator: Mine Tirnaksiz, Altinbas University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mine Tirnaksiz, Principal Investigator, Altinbas University
• ClinicalTrials.gov Identifier: NCT05697432
• Other Study ID Numbers: 81
• First Posted: Jan 25, 2023
• Last Update Posted: Jan 25, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Mine Tirnaksiz, Principal Investigator, Altinbas University: Disabled Children; Oral Hygiene; Streptococcus mutans

Study Results

No Results Posted as of Jan 25, 2023