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Effect of Chlorhexidine Gel on Bacterial Count During Fixed Orthodontic Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02001311
Recruitment Status : Unknown
Verified November 2013 by Dr. Samar Al-Bazi, King Abdulaziz University.
Recruitment status was:  Not yet recruiting
First Posted : December 4, 2013
Last Update Posted : December 4, 2013
Information provided by (Responsible Party):
Dr. Samar Al-Bazi, 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.

Condition or disease Intervention/treatment Phase
Orthodontic Appliance Complication Dental Caries Drug: Chlorhexidine gluconate Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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 : January 2014
Estimated Primary Completion Date : April 2014
Estimated Study Completion Date : June 2014

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

Primary Outcome Measures :
  1. mutants streptococcus count [ Time Frame: 48 hours ]
    measures the change in bacterial count before and after application of the gel

Secondary Outcome Measures :
  1. friction [ Time Frame: 2 minutes ]
    measures static and dynamic friction in Newton

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02001311

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Contact: Mona A Abbassy 0096658349507
Contact: Ahmed S Bakry 00966593944171

Sponsors and Collaborators
King Abdulaziz University
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Principal Investigator: Samar M Al-Bazi King Abdulaziz University

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Dr. Samar Al-Bazi, Doctor, King Abdulaziz University Identifier: NCT02001311     History of Changes
Other Study ID Numbers: 123
First Posted: December 4, 2013    Key Record Dates
Last Update Posted: December 4, 2013
Last Verified: November 2013
Keywords provided by Dr. Samar Al-Bazi, King Abdulaziz University:
chlorhexidine gel
orthodontic brackets
orthodontic patients
bacterial count
Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Dermatologic Agents