A Clinical Trial to Test the Effect of a Marketed Mouth Rinse on Stain Removal
Condition: Tooth Stain
MeSH terms: Tooth Discoloration
Study type: Interventional

Summary: 
      The whitening action of an investigative hydrogen peroxide/sodium fluoride containing mouth
      rinse will be evaluated through stain removal using mean Lobene Stain Index over 14 days
      compared to a currently marketed hydrogen peroxide containing whitening mouth rinse (Crest®
      3D White Multi-Care Whitening Rinse, Glamorous White, Fresh Mint). A currently marketed
      toothpaste (Colgate® Cavity Protection) will be included as the negative control in order to
      compare to brushing alone.

      225 healthy volunteers will be enrolled in this two week study. Volunteers who qualify to be
      in this study will have an equal chance of being assigned to one of the three treatment
      groups. Volunteers will have a total of 5 clinic visits including 1) screening, 2) baseline
      3) Day 4 (after 3 days of use), Day 8 (after 7 days of use) and Day 15 (after 14 days of
      use). Volunteers will maintain a diary at home to record each treatment use. Examinations for
      oral hard/soft tissue assessment and extrinsic tooth stain after the subject brushes with
      water and floss will be completed at Baseline and repeated at Clinic Visits 3, 4, and 5,
      which are on Days 4, 8 and 15 post baseline (i.e., after 3, 7, and 14 days of product use).
    

Detailed description: 
      Approximately 225 generally healthy subjects that meet the required inclusion/exclusion
      criteria will be enrolled in this 2 week, examiner-blind, single center, randomized,
      controlled, parallel-group clinical trial to ensure that approximately 215 subjects complete
      the study. At baseline, the prescreened subjects will present to the clinical site for
      baseline examinations (oral tissue assessment, extrinsic tooth stain assessment). Subjects
      will brush with water, then floss, have an oral exam and tooth stain assessment. Subjects
      will be randomly assigned to one of three groups using a randomized code provided by the
      sponsor:

        -  Negative Control - Brushing twice daily with an ADA - Accepted fluoride-containing
           dentifrice (Colgate® Cavity Protection).

        -  Brushing twice daily with an ADA - Accepted fluoride-containing dentifrice (Colgate®
           Cavity Protection) followed by rinsing twice daily with 10 ml for 60 seconds with an
           investigative peroxide and fluoride containing mouth rinse

        -  Brushing twice daily with an ADA - Accepted fluoride-containing dentifrice (Colgate®
           Cavity Protection) followed by rinsing twice daily with 15 ml for 60 seconds with Crest®
           3D White Multi-Care Whitening Rinse, Glamorous White, Fresh Mint

      Immediately after randomization, subjects will begin use of their assigned test treatment.
      The site staff will supervise the first rinse treatment, and rinse treatments occurring on
      examination days. The negative control group will not have supervised brushing at the clinic
      to avoid the possibility of changing their usual brushing habits. All home use will be
      unsupervised and following label instructions. Subjects will be required to maintain a diary
      card to document twice-daily product use by recording their assigned oral care routine. For
      Clinic Visit 3, 4, and 5, subjects will be instructed to not use the treatment rinse in the
      morning prior to their clinic visit, because that treatment rinse will be supervised during
      their clinic visit. Subjects may brush as normal in the morning prior to these clinic visits.

      During the study, subjects will follow their usual interdental cleaning (e.g. flossing) and
      dietary habits. Subjects will not be allowed to use any other unassigned oral care products
      (mouth rinse, dentifrice, or other tooth whitening products), or have their teeth
      professionally polished, bleached, or whitened by a dentist or hygienist.

      Examinations for oral hard/soft tissue assessment and extrinsic tooth stain after the subject
      brushes with water and floss will be repeated at Clinic Visits 3, 4, and 5, which are on Days
      4, 8 and 15 post baseline (i.e., after 3, 7, and 14 days of product use). Compliance will be
      evaluated at Visits 3, 4, and 5 by weighing residual volumes of returned mouth rinses and by
      reviewing the subject diary. Subjects will receive the ADA-Accepted fluoride containing
      dentifrice and a soft bristled toothbrush at their baseline visit.

      During the course of the study, subjects may use an interdental cleaning device to remove
      impacted food between the teeth and may continue using an interdental cleaning device
      regularly if it is part of their usual oral care regimen.
    

Intervention name(s): Colgate® Regular Cavity Protection; Experimental Mouth Rinse; Crest® 3D White Multi-Care Whitening Rinse, Glamorous White, Fresh Mint
Intervention type(s): Drug; Drug; Other
Intervention description(s): Brushing twice daily with an ADA - Accepted fluoride - containing dentifrice (Colgate Cavity Protection); Brushing twice daily with an ADA - Accepted containing toothpaste, followed by rinsing with 10 mL for 60 seconds with the investigational product.; Brushing twice daily with an ADA - Accepted containing toothpaste, followed by rinsing with 15 mL for 60 seconds with the active comparator.
Intervention MeSH terms: Listerine; Sodium Fluoride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Keywords: Staining; Intensity; Area