An Efficacy Study of Chlorhexidine Mouthwashes

NCT01751178 | Completed Phase 4 Results

• 1 other identifier: RH01561
• Study Type: interventional
• Target: 324
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

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

  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)

  Change from baseline to 6 weeks

Secondary Outcomes (3)

• 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

Study Arms (2)

Mouthwash with Alcohol

ACTIVE COMPARATOR

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.

Drug: Chlorhexidine Digluconate Mouthwash with Alcohol

Mouthwash without Alcohol

ACTIVE COMPARATOR

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.

Drug: Chlorhexidine Digluconate Mouthwash without Alcohol

Interventions

Chlorhexidine Digluconate Mouthwash with Alcohol DRUG

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

Mouthwash with Alcohol

Chlorhexidine Digluconate Mouthwash without Alcohol DRUG

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

Mouthwash without Alcohol

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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) 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.
• \. b) An employee of any toothpaste manufacturer or their immediate family.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (3)

Intertek 4-Front Research - Widnes

Widnes, Cheshire, WA8 6PG, United Kingdom

Location

4Front, Ellesmere Port

Cheshire, CH65 4BW, United Kingdom

Location

Intertek - Manchester Science Park

Manchester, M15 6SE, United Kingdom

Location

MeSH Terms

Conditions

Gingivitis

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2012
• First Posted: December 17, 2012
• Study Start: October 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: July 28, 2014
• Results First Posted: July 28, 2014

Record last verified: 2014-06

Locations

GB (3)