Effect of Chlorhexidine Gel on Bacterial Count During Fixed Orthodontic Treatment

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2013 by King Abdulaziz University
Sponsor:
Information provided by (Responsible Party):
Dr. Samar Al-Bazi, King Abdulaziz University
ClinicalTrials.gov Identifier:
NCT02001311
First received: November 20, 2013
Last updated: November 27, 2013
Last verified: November 2013
  Purpose

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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 King Abdulaziz University:

Primary Outcome Measures:
  • mutants streptococcus count [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    measures the change in bacterial count before and after application of the gel


Secondary Outcome Measures:
  • friction [ Time Frame: 2 minutes ] [ Designated as safety issue: No ]
    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

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02001311

Contacts
Contact: Mona A Abbassy 0096658349507 monaabbassy@gmail.com
Contact: Ahmed S Bakry 00966593944171 drahmedbakry@gmail.com

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

No publications provided

Responsible Party: Dr. Samar Al-Bazi, Doctor, King Abdulaziz University
ClinicalTrials.gov Identifier: NCT02001311     History of Changes
Other Study ID Numbers: 123
Study First Received: November 20, 2013
Last Updated: November 27, 2013
Health Authority: Saudi Arabia: Research Advisory Council
Saudi Arabia: Ethics Committee
Saudi Arabia: Ministry for Higher Education
Saudi Arabia: Ministry of Health

Keywords provided by King Abdulaziz University:
chlorhexidine gel
orthodontic brackets
orthodontic patients
bacterial count
friction

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Disinfectants
Dermatologic Agents

ClinicalTrials.gov processed this record on July 26, 2014