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Effect of a Commercial Cosmetic Mouth Rinse on Plaque Re-growth

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01122862
First received: May 11, 2010
Last updated: January 25, 2012
Last verified: January 2012
History of Changes
  Purpose

A clinical study to evaluate the effect of a commercial mouth rinse on plaque re-growth


Condition Intervention Phase
Healthy Subjects
 Other: Sterile water
Other: Cosmetic mouthrinse
Drug: 0.12% chlorhexidine mouthrinse
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Clinical Study to Evaluate the Effect of a Commercial Cosmetic Mouth Rinse on Plaque Re-growth

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Change from baseline Plaque Index as measured by the Turesky modification of Quigley Hein Index [ Time Frame: baseline to 4 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline Plaque Index as measured by the Turesky modification of Quigley Hein Index [ Time Frame: baseline 24 hours ] [ Designated as safety issue: No ]
  • Change from Baseline Interproximal Plaque Index [ Time Frame: Baseline to 4 days ] [ Designated as safety issue: No ]

Enrollment: 23
Study Start Date: April 2010
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Sterile Water
Sterile Water
 Other: Sterile water
Sterile water
Active Comparator: Cosmetic mouthrinse
Commercially available cosmetic mouthrinse
 Other: Cosmetic mouthrinse
Commerically available cosmetic mouthrinse
Active Comparator: 0.12% Chlorhexidine Mouthrinse
Commercially available 0.12% Chlorhexidine mouthrinse
 Drug: 0.12% chlorhexidine mouthrinse
commercially available 0.12% chlorhexidine mouthrinse

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Good general and oral health
  • At least 20 natural gradable teeth
  • Mean plaque score (Turesky Modification of the Quigley Hein Index) of greater than or equal to 2.00 at the first baseline visit
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01122862

Locations
United States, Indiana
GSK Investigational Site
Fort Wayne, Indiana, United States, 46825
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01122862     History of Changes
Other Study ID Numbers: Z36420889
Study First Received: May 11, 2010
Last Updated: January 25, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by GlaxoSmithKline:
tooth plaque

Additional relevant MeSH terms:
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
 Therapeutic Uses
Pharmacologic Actions
Disinfectants
Dermatologic Agents

ClinicalTrials.gov processed this record on May 19, 2013