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Effect of Chlorhexidine Gel on Bacterial Count During Fixed Orthodontic Treatment

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2013 by Dr. Samar Al-Bazi, King Abdulaziz University.
Recruitment status was:  Not yet recruiting
Information provided by (Responsible Party):
Dr. Samar Al-Bazi, King Abdulaziz University Identifier:
First received: November 20, 2013
Last updated: November 27, 2013
Last verified: November 2013

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 Intervention Phase
Orthodontic Appliance Complication Dental Caries Drug: Chlorhexidine gluconate Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Dr. Samar Al-Bazi, King Abdulaziz University:

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

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

Estimated Enrollment: 20
Study Start Date: January 2014
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: chlorhexidine gel
anti microbial agent that prevents the formation of plaque and reduces caries risk
Drug: Chlorhexidine gluconate


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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT02001311

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

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr. Samar Al-Bazi, Doctor, King Abdulaziz University Identifier: NCT02001311     History of Changes
Other Study ID Numbers: 123
Study First Received: November 20, 2013
Last Updated: November 27, 2013

Keywords provided by Dr. Samar Al-Bazi, King Abdulaziz University:
chlorhexidine gel
orthodontic brackets
orthodontic patients
bacterial count

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Dermatologic Agents processed this record on September 21, 2017