Effect of Chlorhexidine Gel on Bacterial Count During Fixed Orthodontic Treatment

November 27, 2013 updated by: Dr. Samar Al-Bazi, King Abdulaziz University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mutants streptococcus count
Time Frame: 48 hours
measures the change in bacterial count before and after application of the gel
48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
friction
Time Frame: 2 minutes
measures static and dynamic friction in Newton
2 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Abdulaziz University

Investigators

  • Principal Investigator: Samar M Al-Bazi, King Abdulaziz University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Anticipated)

April 1, 2014

Study Completion (Anticipated)

June 1, 2014

Study Registration Dates

First Submitted

November 20, 2013

First Submitted That Met QC Criteria

November 27, 2013

First Posted (Estimate)

December 4, 2013

Study Record Updates

Last Update Posted (Estimate)

December 4, 2013

Last Update Submitted That Met QC Criteria

November 27, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 123 (Giresun University Scientific Research Project)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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