Efficacy of ClōSYS® Sensitive Fluoride Toothpaste and ClōSYS® Sensitive Rinse Regimen on MGI, PI and BOP
Condition: Gingivitis; Periodontitis
MeSH terms: Gingivitis; Periodontitis; Hypersensitivity
Intervention: ClōSYS® Sensitive Fluoride Toothpaste; ClōSYS® Sensitive Rinse
Intervention description: ClōSYS® Sensitive Fluoride Toothpaste is an over-the-counter drug product containing 0.12% stabilized chlorine dioxide (sodium chlorite in an aqueous solution) and 0.13% w/v fluoride ion.; ClōSYS® Sensitive Rinse is a cosmetic product containing 0.1% stabilized chlorine dioxide.
Intervention MeSH terms: Fluorides
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Gingivitis or periodontitis (Stage I or II)

Summary:

      90-day, self-controlled, longitudinal, non-blinded clinical trial which will measure changes
      in clinical parameters in participants with gingivitis and Stage I or II periodontitis who
      apply ClōSYS® Sensitive Fluoride Toothpaste and ClōSYS® Sensitive Rinse.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects are between the ages of 18 to 80 years

          -  Subjects have a minimum of 20 permanent teeth, excluding third molars

          -  Subjects have been diagnosed with gingivitis or periodontitis (Stages I and II are
             based on the level of CAL and Bone Loss (BL). The diagnosis is Stage I if: (a) BL is
             less than 15% and (b) CAL is between 1-2mm. The diagnosis is Stage II if: (a) BL is
             between 15% and 33% and (b) CAL is between 3-4mm)

          -  Subjects exhibit bleeding upon probing in >20% of sites

          -  Subject is seen every 3 months for routine dental prophylaxis/periodontal maintenance

          -  Subjects do not have a significant medical history or metabolic diseases (diabetes
             with A1C ≥ 7.0, pregnancy)

          -  Subject is currently a non-smoker or has discontinued smoking at least 6 months prior
             to enrollment

          -  Subject agrees to refrain from use of the following products: Peridex®, PerioGuard®,
             Listerine®, Cepacol®, Crest Pro-Health® rinse, Colgate Total® rinse, Colgate Total®
             toothpaste, Crest Pro Health® toothpaste, or any generic equivalent while
             participating in this study. Alcohol is not the active ingredient in any oral rinse
             product and does not produce a significant antibacterial effect

          -  Subject is able to read and provide written informed consent

          -  Subject is able to follow verbal and/or written instructions, perform oral hygiene
             procedures and return to the test facility for specified study examinations

          -  Subject agrees not to receive a dental "cleaning" (prophylaxis) while in the study

          -  Subject must permanently reside in Arizona

        Exclusion Criteria:

          -  Subject has significant medical history or poorly controlled/uncontrolled diabetes (as
             defined above)

          -  Subject is pregnant

          -  Subject has a medical condition that requires antibiotic premedication prior to dental
             treatment

          -  Subject has taken antibiotics within 1 month of study enrollment

          -  Subject who takes multiple medications and/or herbal and dietary supplements known to
             alter bleeding and exhibits/reports spontaneous gingival bleeding

          -  Subject takes medications that may interfere with study results (eg. antibiotics,
             steroids, immunosuppressants, high dose aspirin (325+ mg/day), chemotherapy and/or
             radiation therapy for cancer).

          -  Subject is a current smoker

          -  Subject has a history of non-surgical or surgical periodontal therapy within 6 months
             of study participation

          -  Subject has Stage III or IV periodontitis, Grade B or C

          -  Subject is currently taking or in the past 28 days has taken another investigational
             drug or participated in other investigational studies that may impact study outcomes

          -  Subject has not had a dental cleaning within six months prior to the start of the
             study