Flossing With Chlorhexidine

Gingivitis Clinical Trial

Official title:

The Effects of Flossing With a Chlorhexidine Solution on Interproximal Gingivitis: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00471783
• Other study ID #: H05-70513
• Status: Completed
• Phase: Phase 3
• First received: May 8, 2007
• Last updated: August 13, 2008
• Start date: April 2006
• Est. completion date: December 2006

Study information

• Verified date: August 2008
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gingivitis

Intervention

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

Locations

Country	Name	City	State
Canada	Dr. Ian Low	2031 West 41st Avenue, Vancouver	British Columbia

Sponsors (3)

Lead Sponsor	Collaborator
University of British Columbia	British Columbia Dental Hygienists' Association (BCDHA), Canadian Foundation for Dental Hygiene Research and Education

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		3 months	No