Clinical Study to Evaluate the Efficacy of Chlorhexidine Mouthwashes

GlaxoSmithKline3 sites in 1 country324 target enrollmentOctober 2012

ConditionsGingivitis

InterventionsChlorhexidine Digluconate Mouthwash with Alcohol Chlorhexidine Digluconate Mouthwash without Alcohol

DrugsChlorhexidine Digluconate Mouthwash with Alcohol Chlorhexidine Digluconate Mouthwash without Alcohol

Overview

Phase: Phase 4
Intervention: Chlorhexidine Digluconate Mouthwash with Alcohol
Conditions: Gingivitis
Sponsor: GlaxoSmithKline
Enrollment: 324
Locations: 3
Primary Endpoint: Gingival Severity Index (GSI) Based on the Gingival Index (GI)
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The aim of this study is to compare subject gingival health after 6 weeks of twice daily use of a non-alcohol or alcohol containing mouthrinse and brushing compared to brushing only.

Registry

clinicaltrials.gov

Start Date

October 2012

End Date

March 2013

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or oral/ dental examination.
•a) Good oral health in the opinion of the investigator (allowing mild to moderate gingivitis to meet entry criteria).
•b) A minimum of 20 permanent gradable teeth at screening. (Gradable teeth are those where restorative materials cover less than 25% of the tooth surface graded).
•c) Mild to moderate gingivitis present at the screening visit in the opinion of the investigator.
•d) Positive response to bleeding on brushing exercise at screening visit. e) A total of 20 bleeding sites or greater at baseline visit.

Exclusion Criteria

•Known or suspected intolerance or hypersensitivity to Chlorhexidine or other study materials (or closely related compounds) or any of their stated ingredients.
•a) Current or relevant history of any serious, severe or unstable physical or psychiatric illness or any other medical condition (e.g. Diabetes Mellitus) that would make the subject unlikely to fully complete the study or any that increases the risk to the subject or undermines the data validity.
•b) Subjects requiring prophylactic antibiotic treatment prior to dental therapy.
•c) Use of concomitant medication that, in the opinion of the investigator, might interfere with the outcome of the study or increases the risk to the subject (eg: phenytoin, calcium antagonists, cyclosporine, warfarin, antibiotics, immuno-suppressants).
•d) Use of antibiotics within two weeks prior to the screening visit or throughout the study.
•e) Use of any systemic medication which would have an effect on gingival conditions within 14 days of gingival examinations (eg: ibuprofen or aspirin therapy)
•a) Have current active caries b) More than 3 pockets with 5mm or over. c) Excessive calculus present that interferes with the probing examination for Gingival Index.
•d) Other severe oral/ gingival conditions (e.g. Acute Necrotizing Ulcerative Gingivitis) that may compromise the study or the subjects in the opinion of the investigator or gingivitis examiner.
•e) Medical conditions which may directly influence gingival bleeding. f) Restorations in a poor state of repair. g) Orthodontic appliances anterior cosmetic restorations and veneers. h) Enamel pitting/irregularities.
•Subjects using chewing tobacco, pan, pan-masala, gutkha or other chewing tobacco products or subjects who have quit using any of those within the past six months prior to screening.

Arms & Interventions

Mouthwash with Alcohol

rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash with alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.

Intervention: Chlorhexidine Digluconate Mouthwash with Alcohol

Mouthwash without Alcohol

rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash without alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.

Intervention: Chlorhexidine Digluconate Mouthwash without Alcohol

Outcomes

Primary Outcomes

Gingival Severity Index (GSI) Based on the Gingival Index (GI)

Time Frame: Change from baseline to 6 weeks

Measure of gingival severity averaged across whole mouth site; each site scored 0, 1, 2, 3 based on GI and, 1. GSI = 0 if GI is 0 or 1 (no bleeding) 2. GSI = 1 if GI is 1 or 2 (bleeding)

Secondary Outcomes

Gingival Index(Change from baseline to 6 weeks)
Turesky Modification of Quigley & Hein Plaque Index for Overall Plaque Scores(Change from baseline to 6 weeks)
Turesky Modification of Quigley & Hein Plaque Index for Interproximal Plaque Scores(Change from baseline to 6 weeks)