Last updated: 11/04/2018 10:26:34
An Efficacy Study of Chlorhexidine Mouthwashes
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Clinical study to evaluate the efficacy of chlorhexidine mouthwashes
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Single (Investigator)
Allocation:
Randomized
Primary outcomes:
Gingival Severity Index (GSI) based on the Gingival Index (GI)
Timeframe: Change from baseline to 6 weeks
Secondary outcomes:
Gingival Index
Timeframe: Change from baseline to 6 weeks
Turesky modification of Quigley & Hein plaque index for Overall Plaque scores
Timeframe: Change from baseline to 6 weeks
Turesky modification of Quigley & Hein plaque index for Interproximal Plaque scores
Timeframe: Change from baseline to 6 weeks
Interventions:
Drug: Chlorhexidine Digluconate Mouthwash with Alcohol
Drug: Chlorhexidine Digluconate Mouthwash without Alcohol
Enrollment:
324
Observational study model:
Not applicable
Primary completion date:
2013-31-03
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Gingivitis
Product
Chlorhexidine digluconate
Collaborators
Not applicable
Study date(s)
October 2012 to March 2013
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
18 - 64 years
Accepts healthy volunteers
Yes
- 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).
- 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.
Inclusion and exclusion 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.
Trial location(s)
Location
4Front, Ellesmere Port
Cheshire, Not Available, United Kingdom, CH65 4BW
Status
Study Complete
Location
Intertek 4-Front Research - Widnes
Widnes, Cheshire, United Kingdom, WA8 6PG
Status
Will Be Recruiting
Location
Intertek - Manchester Science Park
Manchester, Not Available, United Kingdom, M15 6SE
Status
Study Complete
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2013-31-03
Actual study completion date
2013-31-03
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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