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NCT02001311 Clinical Trial

Effect of Chlorhexidine Gel on Bacterial Count During Fixed Orthodontic Treatment

Dental Caries Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT02001311
Other study ID # 123
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received November 20, 2013
Last updated November 27, 2013
Start date January 2014
Est. completion date June 2014

Study information
Verified date November 2013
Source King Abdulaziz University
Contact Mona A Abbassy
Phone 0096658349507
Email monaabbassy@gmail.com
Is FDA regulated No
Health authority Saudi Arabia: Research Advisory CouncilSaudi Arabia: Ethics CommitteeSaudi Arabia: Ministry for Higher EducationSaudi Arabia: Ministry of Health
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 20
Est. completion date June 2014
Est. primary completion date April 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 30 Years
Eligibility 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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• Chlorhexidine gluconate

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
King Abdulaziz University

Outcome
Type Measure Description Time frame Safety issue
Primary mutants streptococcus count measures the change in bacterial count before and after application of the gel 48 hours No
Secondary friction measures static and dynamic friction in Newton 2 minutes No
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