Effect of Chlorhexidine Gel on Bacterial Count During Fixed Orthodontic Treatment

Sponsor

King Abdulaziz University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02001311

Collaborator

(none)

Enrollment

Arm

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Orthodontic Appliance Complication Dental Caries	Drug: Chlorhexidine gluconate	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Effect of Chlorhexidine Gel on Bacterial Count and Orthodontic Brackets During Fixed Orthodontic Treatment; In-vivo & In-vitro Study

Study Start Date :

Jan 1, 2014

Anticipated Primary Completion Date :

Apr 1, 2014

Anticipated Study Completion Date :

Jun 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: chlorhexidine gel anti microbial agent that prevents the formation of plaque and reduces caries risk	Drug: Chlorhexidine gluconate

Arm

Intervention/Treatment

Experimental: chlorhexidine gel

anti microbial agent that prevents the formation of plaque and reduces caries risk

Drug: Chlorhexidine gluconate

Outcome Measures

Primary Outcome Measures

mutants streptococcus count [48 hours]
measures the change in bacterial count before and after application of the gel

Secondary Outcome Measures

friction [2 minutes]
measures static and dynamic friction in Newton

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 30 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.