Evaluate Inflammation Caused by Gingivitis in Adults
Condition: Gingivitis
MeSH terms: Gingivitis; Inflammation
Intervention: Triclosan/Copolymer/fluoride toothpaste; sodium monofluorophosphate toothpaste
Intervention description: Twice daily usage; Twice daily usage
Intervention MeSH terms: Triclosan; Fluorides; Fluorophosphate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 49.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to compare the anti-inflammatory efficacy of a dentifrice
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must be adult males or females 18 to 60 years old

          -  Subjects must be able and willing to follow study procedures and instructions

          -  Subjects must have generalized, moderate plaque-associated gingivitis as determined by
             the Investigator or designee during the screening examination

          -  Subjects must present with at least 20 teeth in the functional dentition, excluding
             third molars

          -  Each subject must have at least four teeth with probing depths of 4-5 millimeters and
             at least 30% of sites bleeding to gentle probing

        Exclusion Criteria:

          -  Subjects who have chronically used (two weeks or more) Total (Triclosan/Copolymer)
             dentifrice within 6 months prior to enrollment

          -  Subjects with gross oral pathology, including widespread caries or chronic neglect,
             extensive restoration, pre-existing gross plaque and calculus, or soft or hard tissue
             tumor of the oral cavity

          -  Subjects with periodontitis as indicated by periodontal pocketing 6 millimeters at
             screening

          -  Subjects with a history of early onset periodontitis or acute necrotizing ulcerative
             gingivitis

          -  Subjects with concomitant endodontic or periodontal therapy other than prophylaxis
             within 6 months prior to enrollment

          -  Subjects with orthodontic appliances or removable partial dentures

          -  Subjects chronically treated (two weeks or more) with any medication known to affect
             inflammation or periodontal status or (aspirin, nonsteroidal anti-inflammatory drugs,
             steroids, statins, phenytoin, calcium antagonists, cyclosporin and coumadin) within
             one month of the screening examination. All other medications for chronic medical
             conditions should be initiated at least three months prior to enrollment

          -  Subjects who currently smoke or who report using tobacco products within one year of
             screening.

          -  Subjects who have been treated with antibiotics for medical or dental reasons within 3
             months prior to enrollment

          -  Subjects having clinically significant or unstable organic disease; subjects having
             compromised healing potential such as those with diabetes mellitus or connective
             tissue disorders; subjects having heart murmurs, histories of rheumatic fever,
             valvular disease or prosthetic joint replacement necessitating antibiotic prophylaxis

          -  Female subjects who report being pregnant

          -  Subjects who use hormonal contraceptives must have started the method 30 days prior to
             the screening examination.

          -  Subjects with active infectious diseases such as hepatitis, human immunodeficiency
             virus or Tuberculosis

          -  Subjects diagnosed with human immunodeficiency virus (HIV) or subjects that are
             immunocompromised as determined by the Investigator

          -  Medical condition which precludes not eating/drinking for approximately 8 hours.