An Efficacy Study of Chlorhexidine Mouthwashes

NCT ID: NCT01751178

Last Updated: 2014-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 324 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2013-03-31

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.

Conditions

Gingivitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Chlorhexidine Digluconate Mouthwash with Alcohol

Intervention Type: DRUG

0.2% w/v Chlorhexidine Digluconate, alcohol containing - UK Marketed Mouthwash

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.

Group Type: ACTIVE_COMPARATOR

Chlorhexidine Digluconate Mouthwash without Alcohol

Intervention Type: DRUG

0.2% w/v Chlorhexidine Digluconate, without alcohol - UK Marketed Mouthwash

Interventions

Chlorhexidine Digluconate Mouthwash with Alcohol

0.2% w/v Chlorhexidine Digluconate, alcohol containing - UK Marketed Mouthwash

Intervention Type: DRUG

Chlorhexidine Digluconate Mouthwash without Alcohol

0.2% w/v Chlorhexidine Digluconate, without alcohol - UK Marketed Mouthwash

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

Intertek 4-Front Research - Widnes

Widnes, Cheshire, United Kingdom

4Front, Ellesmere Port

Cheshire, , United Kingdom

Intertek - Manchester Science Park

Manchester, , United Kingdom

Countries

United Kingdom

Other Identifiers

RH01561

Identifier Type: -

Identifier Source: org_study_id