An Efficacy Study of Chlorhexidine Mouthwashes
Condition: Gingivitis
MeSH terms: Gingivitis
Intervention: Chlorhexidine Digluconate Mouthwash with Alcohol; Chlorhexidine Digluconate Mouthwash without Alcohol
Intervention description: 0.2% w/v Chlorhexidine Digluconate, alcohol containing - UK Marketed Mouthwash; 0.2% w/v Chlorhexidine Digluconate, without alcohol - UK Marketed Mouthwash
Intervention MeSH terms: Ethanol; Chlorhexidine; Chlorhexidine gluconate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 324.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: Accepts Healthy Volunteers

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.
    

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.

             5. 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.

          -  5. 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) 6. 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. 7. 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.

             8. b) An employee of any toothpaste manufacturer or their immediate family.