Clinical Efficacy Evaluation of Three Dentifrices
Condition: Gingival Inflammation and Bleeding; Dental Plaque
MeSH terms: Gingivitis; Dental Plaque; Inflammation
Intervention: Dentifrices
Intervention description: Dentifrice on plaque, gingivitis, and bleeding.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 319.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      Clinical study to evaluate and compare the efficacy of two baking soda containing
      dentifrices, containing 20% and 35% baking soda, to a non-baking soda dentifrice for their
      ability to reduce gingivitis and plaque following 6-months of use.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have provided written informed consent prior to being entered into the study.

          -  Be between 18 and 70 years of age, male or female.

          -  Have at least eighteen (18) natural teeth with scorable facial and lingual surfaces as
             determined by the Examiner. Teeth that are grossly carious, orthodontically banded,
             exhibiting general cervical abrasion and/or enamel abrasion, or third molars will not
             be included in the tooth count.

          -  Have a mean baseline plaque index score ≥ 1.95 as determined by the Soparkar
             Modification of the Turesky Modification of the Quigley-Hein Plaque Index (Pl).

          -  Have a mean baseline gingival index score of ≥ l.70 and ≤ 3.0 as determined by the
             Modified Gingival Index (MGI).

          -  Presence of ≥ 10 bleeding sites upon probing.

          -  Agree not to have a dental prophylaxis or any other elective, non-emergency dental
             procedures any time during the study.

          -  Agree to abstain from the use of chewing gum, mouth rinses, any toothpaste other than
             the study toothpaste, tooth whitening products (either professional or at home use)
             and all other oral hygiene other than the study procedures for the duration of the
             study.

          -  Agree to refrain from all oral hygiene on the morning of each evaluation visit and to
             refrain from eating, drinking, and smoking for 4 hrs, prior to each evaluation visit.

          -  Agree to comply with the conditions and schedule of the study.

        Exclusion Criteria:

          -  Physical limitations or restrictions that might preclude normal tooth brushing.

          -  Evidence of gross oral pathology, including widespread caries or chronic neglect,
             extensive restoration, preexisting gross plaque or soft or hard tissue tumor of the
             oral cavity.

          -  Heavy supra- or subgingival calculus that might interfere with evaluations as
             determined by the Investigator/Examiner.

          -  Evidence of major oral hard or soft tissue lesions or trauma at the baseline visit as
             determined by the Investigator/Examiner.

          -  Conditions requiring antibiotic treatment prior to dental procedures.

          -  History of uncontrolled diabetes or hepatic or renal disease, or other serious
             conditions or transmittable diseases, (e.g. cardiovascular disease, AIDS).

          -  Subjects with grossly carious, fully crowned, or extensively restored teeth,
             orthodontic appliances, peri/oral piercings, or removable partial dentures.

          -  Treatment with antibiotics within the 1-month period before the baseline examination,
             or a condition that is likely to require antibiotic treatment over the course of the
             trial.

          -  Chronic treatment (2 weeks or more) with any medication known to affect periodontal
             status (including phenytoin, calcium antagonists, cyclosporine, coumarin, nonsteroidal
             anti-inflammatory drugs, and aspirin) within 1 month of the baseline examination. All
             other medications for chronic medical conditions must have been initiated at least 3
             months before enrollment.

          -  Have severe periodontal disease or being actively treated for periodontal disease.

          -  Having history of early-onset periodontitis or acute necrotizing ulcerative
             gingivitis.

          -  Concomitant periodontal therapy other than prophylaxis in the last 6 months.

          -  Professional prophylaxis within 1 month prior to the baseline clinical evaluation.

          -  Subjects who participated in a gingivitis study in the past month.

          -  Daily use of chemotherapeutic antiplaque/antigingivitis products within the past 4
             months.

          -  History of significant adverse effects following use of oral hygiene products such as
             toothpastes and mouthrinses.

          -  Subjects who are allergic to any ingredients in the test or control product, as listed
             on the IRB Safety Assessment.

          -  Self-reported pregnancy and nursing since hormonal changes can exaggerate gingival
             response to dental plaque.