Effect of Chlorhexidine Gel on Bacterial Count During Fixed Orthodontic Treatment

Phase 1

• Conditions: Orthodontic Appliance Complication; Dental Caries
• Interventions: Drug: Chlorhexidine gluconate

• Registration Number: NCT02001311
• Lead Sponsor: King Abdulaziz University

Brief Summary

This study investigates the benefit of using chlorhexidine gel as an antimicrobial agent in orthodontic patient to reduce caries risk and the possible consequential effect of this use on the orthodontic brackets used for the treatment.

The investigators hypothesis is that chlorhexidine gel use can reduce caries risk in orthodontic patients with out causing damage to the bonded ceramic or metal orthodontic brackets.

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-11
• Study First Submitted: 2013-11-20
• Study First Submitted QC: 2013-11-27
• Last Update Submitted: 2013-11-27
• Study First Posted: 2013-12-04
• Last Update Posted: 2013-12-04
• Study Start: 2014-01
• Primary Completion: 2014-04
• Study Completion: 2014-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Patients' age range from 18-30 years.
• Fixed orthodontic treatment.
• All the patients are at the end of leveling and alignment stage.
• Initial bacterial count indicates high caries risk.
• All patients will be given good oral hygiene instruction at the first visit.
• The subjects had not taken antibiotics for at least 6 weeks before saliva sampling or during the experimental period.
• All subjects used a fluoride dentifrice twice a day.

Exclusion Criteria

• Patients' age more or less then the age range specified.
• Removable orthodontic treatment.
• Patients at early stages of leveling and alignment.
• Initial bacterial count indicates low caries risk.
• Subjects that have taken antibiotics for at least 6 weeks before saliva sampling.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
chlorhexidine gel	Chlorhexidine gluconate	anti microbial agent that prevents the formation of plaque and reduces caries risk

Primary Outcome Measures

Name	Time	Method
mutants streptococcus count	48 hours	measures the change in bacterial count before and after application of the gel

Secondary Outcome Measures

Name	Time	Method
friction	2 minutes	measures static and dynamic friction in Newton