Trial Outcomes & Findings for Safety and Tolerability of Antiplaque Chewing Gum in a Gingivitis Population (NCT NCT01877421)

There were a total of 137 planned subjects (71 in Phase 1 and 66 in Phase 2) to participate in this study at the Oral Health Research Institute, Indiana University School of Dentistry. There were a total of 135 enrolled (71 in Phase 1 and 64 in Phase 2). Phase 1 and 2 are individual periods ran in parallel.

Safety and Tolerability of Antiplaque Chewing Gum in a Gingivitis Population

Occurrence of local oral mucosal reactions, systemic reactions such as fever, nausea, headache, and changes in blood pressure, clinical laboratory measures of safety, and serious total body reactions will be assessed (AEs and SAEs)

Data summarizes plaque index scores changes from baseline. Supragingival plaque will be assessed after the MGI and BOP assessments and following use of a disclosing solution on the facial (buccal) and lingual surfaces of a minimum of 16 scorable teeth according to the criteria of the Turesky modification of the Quigley-Hein Plaque Index. Quigley-Hein Plaque Index Scores with Turesky Modifications: 0 No plaque 1. Separate flecks of plaque at the cervical margin of the tooth 2. A thin continuous band of plaque (up to one mm) at the cervical margin of the tooth 3. A band of plaque wider than one mm but covering less than one-third of the crown of the tooth 4. Plaque covering at least one-third but less than two thirds of the crown of the tooth 5. Plaque covering two-thirds or more of the crown of the tooth

Data summarizes gingival index scores changes from baseline in phase 2a. Gingivitis will be assessed using both the MGI (Modified Gingival Index) and the Gingival Bleeding Index (BOP) The Modified Gingival Index assesses the buccal and lingual gingivae and interdental papillae. Modified Gingival Index Scores: 0 Absence of inflammation 1. Mild inflammation; slight change in color, little change in texture of any portion of but not the entire marginal or papillary gingival unit 2. Mild inflammation; criteria as above but involving the entire marginal or papillary gingival unit 3. Moderate inflammation; glazing, redness, edema and/or hypertrophy of the marginal or papillary gingival unit 4. Severe inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration.

Proof of concept of KSL-W in reducing plaque as measured by percent of bleeding sites upon probing (BOP) in phase 2a. Gingivitis will be assessed using both the MGI (Modified Gingival Index) and the Gingival Bleeding Index (BOP). The Modified Gingival Index assesses the buccal and lingual gingivae and interdental papillae. The Gingival Bleeding Index assesses the percentage of sites that bleed on gentle probing. A periodontal probe (HU-Friedy UNC 15) will be gently inserted into the gingival sulcus until resistance is felt at mid-facial (buccal), mid-lingual, mesial, and distal interproximal sites of all scorable teeth, with the exception of the most posterior distal sites. Presence or absence of bleeding will be recorded for each site and the percentage of bleeding sites per subject will serve as the unit of analysis.