Controlling Oral Malodor by ClōSYS Oral Rinse
Condition: Oral Malodor
Study type: Interventional

Summary: 
      The purpose of this Study is to assess the efficacy of two ClōSYS Oral Rinse products in
      human subjects in controlling oral malodor in partial fulfillment of the requirements for
      recognition by the American Dental Association's (ADA) requirement for obtaining ADA Seal for
      malodor.
    

Detailed description: 
      Study Design:

      The products used in this study are: ClōSYS Alcohol-Free Oral Rinse (referred here as ClōSYS
      Unflavored Oral Rinse) and ClōSYS justRIGHT MILD MINT Oral Rinse (referred here as ClōSYS
      Flavored Oral Rinse). This is an in-vivo, eight-week, a single-center, randomized,
      double-blind (subject/investigator), 2-waycross-overdesign clinical study. There will be two
      independent groups. Each subject of each group will be crossed over to the other group within
      a same group after the washout period. Each group will have their own control group. In the
      first phase, 25 subjects (50%) of each group will randomly be assigned to the active group;
      the other 25 subjects will be assigned to the control group. In the second phase, the
      participants will be crossed over of group assignment. The Study will enroll 100 subjects,
      aged 21 to 65 years, with a slight to strong intrinsic oral malodor, as determined by a panel
      of trained odor judges calibrated and standardized using a range of standard odorants
      sufficient to reflect the different patterns of nose receptors.

      Study Plan:

      Subjects will receive verbal and written oral hygiene instructions, and either one bottle (16
      oz. each) of ClōSYS Unflavored Oral Rinse, ClōSYS Flavored Oral Rinse- or Placebo Oral Rinse
      each week. Subjects will also receive measuring cups for dispensing the rinse and a diary log
      for recording usage (the Oral Hygiene Kit) for use during the treatment. After a 2-week wash
      out period, each subject will receive another bottle of oral rinse according to their group
      assignment. The rinse bottles will be weighed prior to dispensing the product. A product log
      will be maintained and the weights of the bottles will be documented at each visit.

      Subjects will be instructed to rinse twice a day, each in the morning and in the evening,
      with 15 mL mouth rinse for 30 seconds. They will note in their patient's log the date and
      time of rinsing.

      Subjects will be instructed to continue with their normal oral hygiene practices, including
      tooth brushing and flossing but omitting any use of oral rinses or mouthwashes except for the
      Study materials. The subjects also will be instructed not to use other non-study related
      products such as breath mints, lozenge, gums, etc. as well as refraining from elective dental
      procedures during the study period.
    

Intervention name(s): ClōSYS® Unflavored Rinse; ClōSYS® Flavored Rinse; Placebo-Flavored Oral Rinse; Placebo-Unflavored Oral Rinse
Intervention type(s): Drug; Drug; Other; Other
Intervention description(s): Flavor-matched placebo rinse; Unflavored-matched placebo rinse
Other intervention name(s): Mouth rinse; Mouth rinse
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment