Flossing With Chlorhexidine

Overview

To determine if flossing with a dental floss presoaked in chlorhexidine, an anti-microbial mouth wash, would improve the clinical signs of gingivitis, an inflammation of the gums characterized by red, swollen, bleeding gums. And to determine if applying chlorhexidine via dental floss would result in tooth staining, which is common with chlorhexidine mouthwashes.

Full Title of Study: “The Effects of Flossing With a Chlorhexidine Solution on Interproximal Gingivitis: a Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: December 2006

Detailed Description

Purpose of study: To determine if dental floss presoaked in 0.12% chlorhexidine is more effective at reducing the signs of gingivitis, such as bleeding, than a dental floss in placebo solution of 0.1% quinine sulphate. Trial design: The study will consist of a double-blinded, placebo-controlled parallel three-month clinical trial. Randomization of subjects into study groups: Subjects randomized with a computer-generated randomization table and balanced block design to make the two groups equal in number of subjects. Trial schedule: 1. Screening for potential subjects & consent obtained. Calibration of examiner. 2. Week -1: Professional prophylaxis consisting of scaling and polishing. 3. Week 0: Baseline data (GI, SI, PI, BOP, PD) collected on subjects enrolled into the study. OHI – flossing. Subject randomized into a study group. 4. Week 6: Subjects reassessed for GI, SI, PI, BOP, PD. Compliance check. Replenish floss supply. Subject concerns or questions addressed. 5. Week 12: Subjects reassessed for GI, SI, PI, BOP, PD. All floss boxes and logbook returned. Subject concerns or questions addressed. Subject exited from study and returned to the care of his or her regular dental professional. Measurements for data collection (done in this order): 1. Gingival index (GI) (modification of Löe & Silness, 1963) 2. Stain Index (SI) 3. Plaque index (PI) (modification of Silness and Löe, 1964) 4. Bleeding on Probing (BOP) 5. Probing Depth (PD)

Interventions

  • Procedure: Chlorhexidine is the generic name of the mouthwash, Peridex is the brand name.

Clinical Trial Outcome Measures

Primary Measures

  • To determine if dental floss presoaked in 0.12% chlorhexidine is more effective at reducing the signs of gingivitis, such as bleeding, than a dental floss in placebo solution of 0.1% quinine sulphate.
    • Time Frame: 3 months

Participating in This Clinical Trial

Inclusion Criteria

To be considered for inclusion into the study, subjects must fulfill the following conditions:

  • 18 years and older – Have gingivitis (i.e., have pocket depths of 4 mm or less), but not periodontitis – Willing to floss every day and have the necessary dexterity to floss – Have a minimum of 20 natural teeth, including 4 molars – Have at least 10 bleeding sites – Be a non-smoker Exclusion Criteria:

Subjects will be excluded from the study, if they have any of the following conditions:

  • Pregnant or plan to be pregnant within the next 3 months – Allergic to chlorhexidine or quinine sulphate – Require pre-medication with antibiotics for dental treatment – Currently taking antibiotics – Currently taking Dilantin, Cyclosporin A, Nifedipine or other calcium channel blockers, aspirin or anti-coagulants – Currently using chlorhexidine or whitening products – Have active carious lesions – Have orthodontic braces – Have more than 2 crowns or bridges – Have more than 2 implants – Have full or partial dentures – Have periodontitis, i.e., pocket depths of 5 mm or more in more than 2 sites in the mouth

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of British Columbia
  • Collaborator
    • Canadian Foundation for Dental Hygiene Research and Education
  • Provider of Information About this Clinical Study
    • Dr. Donald Brunette, University of British Columbia
  • Overall Official(s)
    • Donald Brunette, Ph.D, Principal Investigator, University of British Columbia

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