Effect of Chlorhexidine Gel on Bacterial Count During Fixed Orthodontic Treatment

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2014

Interventions

  • Drug: Chlorhexidine gluconate

Arms, Groups and Cohorts

  • Experimental: chlorhexidine gel
    • anti microbial agent that prevents the formation of plaque and reduces caries risk

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • friction
    • Time Frame: 2 minutes
    • measures static and dynamic friction in Newton

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 30 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • King Abdulaziz University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dr. Samar Al-Bazi, Doctor – King Abdulaziz University
  • Overall Official(s)
    • Samar M Al-Bazi, Principal Investigator, King Abdulaziz University
  • Overall Contact(s)
    • Mona A Abbassy, 0096658349507, monaabbassy@gmail.com

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.