Trial Outcomes & Findings for To Investigate the Gingivitis Efficacy of a Stannous Fluoride Dentifrice in a Chinese Population (NCT NCT02937636)

Participants were recruited from one center in China.

A total of 343 participates were screened, out of which 128 participants were randomized in the study. 215 participants were not randomized as 186 participants did not meet study criteria, 5 participants withdrew consent and 24 were not randomized for other reasons (not specified).

To Investigate the Gingivitis Efficacy of a Stannous Fluoride Dentifrice in a Chinese Population

The BI was performed by a single examiner using a color coded periodontal probe. The probe was inserted approximately 1 mm into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system to be used is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed. This measure will be analyzed and summarized over all sites.

Number of bleeding sites were measured as BI via a single examiner using a color coded periodontal probe. The probe was gently inserted approximately 1 millimeter (mm) into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system used to measure bleeding sites is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed. A bleeding site was considered as a BI score of 1 or 2.

The MGI was assessed on facial and lingual surfaces at two sites on each tooth (papillae and margin).The scoring of MGI was performed by a single examiner. The MGI scoring system is as follows:0=absence of inflammation;1=mild inflammation; slight change in color, little change in color; little change in texture of any portion of the marginal or papillary gingival unit;2=mild inflammation; criteria as above but involving the entire marginal or papillar gingival units;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.

The dental examiner used the PI to assess plaque on all gradable teeth. The plaque was first disclosed using a dye solution. Participants then rinsed with disclosing solution according to instructions. Plaque was assessed with each tooth being divided into 6 areas including the mesiofacial, facial, distofacial, mesiolingual, lingual and distolingual surfaces. Disclosed plaque was scored as follows: 0= No plaque; 1= Slight flecks of plaque at the cervical margin of the tooth; 2= A thin continuous band of plaque (1 mm or smaller) at the cervical margin of the tooth; 3= A band of plaque wider than 1 mm but covering less than 1/3 of the crown of the tooth; 4= Plaque covering at least 1/3 but less tan 2/3 of the crown of the tooth; 5= Plaque covering 2/3 or more of the crown of the tooth.Overall PI score and interproximal PI score were calculated as the mean PI over all tooth sites and mean PI over interproximal sites (distal and mesial) respectively.