Clinical trial NCT01751178: An Efficacy Study of Chlorhexidine Mouthwashes
Official title: Clinical Study to Evaluate the Efficacy of Chlorhexidine Mouthwashes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gingivitis
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2012-12-17
Enrollment: 324
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Gingival Severity Index (GSI) Based on the Gingival Index (GI)
timeFrame: Change from baseline to 6 weeks
Secondary outcomes:
measure: Gingival Index
timeFrame: Change from baseline to 6 weeks
measure: Turesky Modification of Quigley & Hein Plaque Index for Overall Plaque Scores
timeFrame: Change from baseline to 6 weeks
measure: Turesky Modification of Quigley & Hein Plaque Index for Interproximal Plaque Scores
timeFrame: Change from baseline to 6 weeks
Other outcomes:
Locations:
city: Widnes
country: United Kingdom
facility: Intertek 4-Front Research - Widnes
state: Cheshire
city: Cheshire
country: United Kingdom
facility: 4Front, Ellesmere Port
city: Manchester
country: United Kingdom
facility: Intertek - Manchester Science Park
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: