Last updated: 11/04/2018 13:49:45

Effect of a commercial cosmetic mouth rinse on plaque re-growth

GSK study ID
Z36420889
See study documents
Clinicaltrials.gov ID
NCT01122862
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A clinical study to evaluate the effect of a commercial cosmetic mouth rinse on plaque re-growth
Trial description: A clinical study to evaluate the effect of a commercial mouth rinse on plaque re-growth
Primary purpose:
Prevention
Trial design:
Crossover Assignment
Masking:
Single (Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:

Plaque Index of Test Mouth Rinse versus Sterile Water after Day 4 of treatment administration

Timeframe: Day 4 post treatment administration

Secondary outcomes:

Plaque Index Score of Test Mouth Rinse versus Chlorhexidine Mouth Rinse after Day 4 of treatment administration

Timeframe: Day 4 post treatment administration

Plaque Index after 24 hours of treatment administration

Timeframe: Day 1 post treatment administration

Interproximal Plaque Index after Day 4 of treatment administration

Timeframe: Day 4 post treatment administration

Interproximal Plaque Index after 24 hours of treatment administration

Timeframe: Day 1 post treatment administration

Interventions:
  • Drug: 0.12% chlorhexidine mouthrinse
  • Other: Cosmetic mouthrinse
  • Other: Sterile water
    • Enrollment:
    23
    Primary completion date:
    2010-31-05
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Healthy Subjects
    Product
    Not applicable
    Collaborators
    Not applicable
    Study date(s)
    April 2010 to May 2010
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    Yes
    • Inclusion Criteria:
    • Good general and oral health
    Inclusion and exclusion criteria
    Inclusion 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

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Fort Wayne, Indiana, United States, 46825
    Status
    Study Complete
    Contact us

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2010-31-05
    Actual study completion date
    2010-31-05

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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