Orodental Hygiene in Children With Special Needs

Study Overview
=================
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.

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

Conditions
-----------------
Oral Hygiene

Intervention / Treatment
-----------------
* Diagnostic Test: Oral Examination
* Diagnostic Test: PUFA index
* Diagnostic Test: Plaque index
* Diagnostic Test: Streptococcus mutans screening
* Behavioral: Education


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Education<br>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<br>* A complete examination of oral and dental hygiene any health problems will be registered<br>Diagnostic Test: PUFA index<br>* An assessment of the presence of oral conditions resulting from untreated caries. P=Pulpal involvement, U=ulceration, F=fistula, A=abscess index<br>* Other names: Pulpal involvement, ulceration, fistula, abscess index;Diagnostic Test: Plaque index<br>* An assessment of the amount of dental plaque visible on the vestibular and lingual surfaces of all teeth. The index varies between 0-4.<br>* Other names: Sillness Löe PI;Diagnostic Test: Streptococcus mutans screening<br>* A strip test for specific bacteria named streptococcus mutans, which plays an important role in caries formation, from patients' collected saliva<br>* Other names: Saliva-check mutans;Behavioral: Education<br>* Education on correct toothbrushing technique, oral hygiene, dietary education on foods detrimental for dental hygiene.<br>|

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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Disabled Children, Oral Hygiene, Streptococcus mutans