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
      American Dental Association's (ADA) requirement for obtaining ADA Seal for malodor.
    

Detailed description: 
      Study Design:

      The products used in the study are: ClōSYS Alcohol-Free Oral Rinse (also referred as ClōSYS
      Unflavored Oral Rinse) and ClōSYS justRIGHT MILD MINT Oral Rinse (also referred as ClōSYS
      Flavored Oral Rinse or Gentle Mint Flavored Oral Rinse). This is an in-vivo, eight-week, a
      single-center, randomized, double-blind (subject/investigator), 2-way cross-over design
      clinical study. There are two independent groups. Each subject of each group gets crossed
      over to the other sub-group within a same group after the washout period. Each group has
      their own control group. In the first phase, 25 subjects (50%) of each group are randomly
      assigned to the active group; the other 25 subjects are assigned to the control group. In the
      second phase, the participants will be crossed over within sub-group assignment. The Study
      enrolled 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.

      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 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
Intervention type(s): Drug; Drug; Other
Intervention description(s): Subjects in Test group will receive ClōSYS® Unflavored Rinse.; Subjects in Test group will receive ClōSYS® Flavored Rinse.; Subjects in Placebo group will receive Placebo Rinse.
Other intervention name(s): Mouth rinse; Mouth rinse
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment