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

Not Applicable

Completed

• Conditions: Disabilities Multiple
• Interventions: Behavioral: chlorhexidine added to the preventive protocol; Behavioral: preventive protocol

• Registration Number: NCT04485312
• Lead Sponsor: Cairo University

Brief Summary

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

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

Study Timeline

• Study Start: 2020-07-15
• Study First Submitted: 2020-07-18
• Study First Submitted QC: 2020-07-23
• Study First Posted: 2020-07-24
• Primary Completion: 2021-07-15
• Study Completion: 2021-07-15
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-11
• Last Update Posted: 2021-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
chlorhexidine varnish added to the caries preventive protocol	chlorhexidine added to the preventive protocol	chlorhexidine varnish preventive caries protocol for special needs
caries preventive protocol	preventive protocol	preventive protocol for special needs ( tooth brushing , topical fluoride and mouth wash)

Primary Outcome Measures

Name	Time	Method
chance to avoid new caries	10 months	% of the green sector in the cariogram

Trial Locations

Locations (1)

School; 🇪🇬 Giza, Egypt