Flossing With Chlorhexidine

Study Overview
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Brief Summary
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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
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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: Screening for potential subjects & consent obtained. Calibration of examiner. Week -1: Professional prophylaxis consisting of scaling and polishing. Week 0: Baseline data (GI, SI, PI, BOP, PD) collected on subjects enrolled into the study. OHI - flossing. Subject randomized into a study group. Week 6: Subjects reassessed for GI, SI, PI, BOP, PD. Compliance check. Replenish floss supply. Subject concerns or questions addressed. 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): Gingival index (GI) (modification of Löe & Silness, 1963) Stain Index (SI) Plaque index (PI) (modification of Silness and Löe, 1964) Bleeding on Probing (BOP) Probing Depth (PD)

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

Conditions
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Gingivitis

Intervention / Treatment
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* Procedure: Chlorhexidine is the generic name of the mouthwash, Peridex is the brand name.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Chlorhexidine is the generic name of the mouthwash, Peridex is the brand name.|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gingivitis, chlorhexidine, dental floss, RCT, bleeding on probing, gingival and plaque indices