An Efficacy Study of Chlorhexidine Mouthwashes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01751178
First received: December 13, 2012
Last updated: July 3, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Gingivitis
Drug: Chlorhexidine Digluconate Mouthwash with Alcohol
Drug: Chlorhexidine Digluconate Mouthwash without Alcohol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Clinical Study to Evaluate the Efficacy of Chlorhexidine Mouthwashes

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Gingival Severity Index (GSI) Based on the Gingival Index (GI) [ Time Frame: Change from baseline to 6 weeks ] [ Designated as safety issue: No ]

    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)


Secondary Outcome Measures:
  • Gingival Index [ Time Frame: Change from baseline to 6 weeks ] [ Designated as safety issue: No ]
    The GI was assessed on the facial and lingual surfaces at six sites on each tooth (facial and lingual - distal papillae, margin and mesial papillae). These assessments were performed on all evaluable teeth using moderate pressure sweeping a blunt ended probe, which was engaged in approximately 1 millimetre (mm) into the gingival crevice. The scores could range from 0-3 (0=Absence of inflammation; 1=Mild Inflammation-Slight change in color slight change in texture, no bleeding on probing; 2=Moderate Inflammation -glazing, redness edema and hypertrophy, bleeding on probing; 3= Severe inflammation-marked redness and hypertrophy, tendency for spontaneous bleeding)

  • Turesky Modification of Quigley & Hein Plaque Index for Overall Plaque Scores [ Time Frame: Change from baseline to 6 weeks ] [ Designated as safety issue: No ]
    Overall plaque scores were calculated taking the average over all tooth sites for a participant. The scores could range from 0-5 (0=No plaque; 1=Slight flecks of plaque at the cervical margin of the tooth; 2= A thin continuous band of plaque (1 mm or smaller) at the cervical margin of the tooth; 3=A band of plaque wider than 1 mm but covering less than 1/3 of the area to be graded of the crown of the tooth; 4=Plaque covering at least 1/3 but less than 2/3 of the area to be graded of the crown of the tooth; 5=Plaque covering 2/3 or more of the area to be graded of the crown of the tooth)

  • Turesky Modification of Quigley & Hein Plaque Index for Interproximal Plaque Scores [ Time Frame: Change from baseline to 6 weeks ] [ Designated as safety issue: No ]
    Interproximal plaque scores were analyzed on the mesiofacial, distofacial, mesiolingual and distolingual surfaces, and calculated taking the average over all tooth sites for a participant. The scores could range from 0-5 (0=No plaque; 1=Slight flecks of plaque at the cervical margin of the tooth; 2= A thin continuous band of plaque (1 mm or smaller) at the cervical margin of the tooth; 3=A band of plaque wider than 1 mm but covering less than 1/3 of the area to be graded of the crown of the tooth; 4=Plaque covering at least 1/3 but less than 2/3 of the area to be graded of the crown of the tooth; 5=Plaque covering 2/3 or more of the area to be graded of the crown of the tooth)


Enrollment: 324
Study Start Date: October 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Drug: Chlorhexidine Digluconate Mouthwash with Alcohol
0.2% w/v Chlorhexidine Digluconate, alcohol containing - UK Marketed Mouthwash
Active Comparator: 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.
Drug: Chlorhexidine Digluconate Mouthwash without Alcohol
0.2% w/v Chlorhexidine Digluconate, without alcohol - UK Marketed Mouthwash

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01751178

Locations
United Kingdom
Intertek 4-Front Research - Widnes
Widnes, Cheshire, United Kingdom, WA8 6PG
4Front, Ellesmere Port
Cheshire, United Kingdom, CH65 4BW
Intertek - Manchester Science Park
Manchester, United Kingdom, M15 6SE
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01751178     History of Changes
Other Study ID Numbers: RH01561
Study First Received: December 13, 2012
Results First Received: May 1, 2014
Last Updated: July 3, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Gingivitis
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Ethanol
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents
Disinfectants
Dermatologic Agents

ClinicalTrials.gov processed this record on August 19, 2014