Chance to Avoid New Caries by Adding Chlorhexidine to the Preventive Protocol in Adolescent Special Needs

Study Overview
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Brief Summary
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Adolescent Special need individuals are most need of easy forms of antibacterial agents, so in this study, using chemotherapeutic agents like the newly introduced varnish containing chlorhexidine seems to be a quite promising tool for local delivery to patients with special needs . Chlorhexidine is a wide spectrum very effective bactericidal used for years against the oral flora while fluorides are well known with their antibacterial ability. This may be an excellent way to reduce the risk assessment in adolescent special needs patients.

Detailed Description
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Participants will be divided into two groups according to the tested regimen, where (A1) represents participants exposed to risk based conventional protocol, (A2) represents participants exposed to chlorhexidine containing varnish and risk based conventional preventive protocol. The study will be carried over a period of 10 months (one academic year), the study will be divided into three phases Phase I: Information of the Cariogram parameters (caries experience, diet content, diet frequency, plaque amount, mutans streptococci, fluoride program, saliva secretion and saliva buffer capacity) will be collected, which will be used to generate the individual caries profile, based on which the participants will be divided into 2 risks groups. Phase II: Risk based preventive program will be implemented including the restorative part. Phase III: At the end of 10 months, caries profile will be generated again

Official Title
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Chance to Avoid New Caries by Adding Chlorhexidine Containing Chemotherapeutic Agent to the Conventional Preventive Protocol for Patients With Special Needs

Conditions
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Disabilities Multiple

Intervention / Treatment
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* Behavioral: preventive protocol
* Behavioral: chlorhexidine added to the preventive protocol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of disability like : autism and down syndrome. Must be able to open his/her mouth for varnish application Exclusion Criteria: systemically unhealthy patients with fetal diseases Age below 13 and above 18

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: caries preventive protocol<br>preventive protocol for special needs ( tooth brushing , topical fluoride and mouth wash) | Behavioral: preventive protocol<br>* preventive protocol<br>|
| Other: chlorhexidine varnish added to the caries preventive protocol<br>chlorhexidine varnish preventive caries protocol for special needs | Behavioral: chlorhexidine added to the preventive protocol<br>* chlorhexidine varnish added to the preventive protocol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| chance to avoid new caries | % of the green sector in the cariogram | 10 months |