MedDataX Logo

Flossing With Chlorhexidine

NCT ID: NCT00471783

Last Updated: 2008-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2006-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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)

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gingivitis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

gingivitis chlorhexidine dental floss RCT bleeding on probing gingival and plaque indices

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Chlorhexidine is the generic name of the mouthwash, Peridex is the brand name.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Canadian Foundation for Dental Hygiene Research and Education

OTHER

Sponsor Role collaborator

British Columbia Dental Hygienists' Association (BCDHA)

INDUSTRY

Sponsor Role collaborator

University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

University of British Columbia

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Donald Brunette, Ph.D

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Dr. Ian Low

2031 West 41st Avenue, Vancouver, British Columbia, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

H05-70513

Identifier Type: -

Identifier Source: org_study_id