Background
Methods
Subjects
Objectives
Procedures and assessments
Modified gingival index and bleeding index
Plaque index
Adverse events
Statistical methods
Sample size
Results
Demographic and baseline characteristics
0.454% SnF2 (n = 50) | Negative(n = 48) | |
---|---|---|
Gender, n (%) | ||
Female | 34 (68.0) | 31 (64.6) |
Male | 16 (32.0) | 17 (35.4) |
Race, n (%) | ||
White | 43 (86.0) | 39 (81.3) |
Black/African-American | 4 (8.0) | 8 (16.7) |
American Indian/Alaska native | 1 (2.0) | 0 (0.0) |
Asian | 0 (0.0) | 1 (2.1) |
Multiple | 2 (4.0) | 0 (0.0) |
Mean age, years (SD) | 39.5 (14.55) | 38.8 (12.44) |
Strata (baseline MGI; Sex) n (%) | ||
≤ 2.0; Male | 5 (10.0) | 5 (10.4) |
> 2.0; Male | 11 (22.0) | 12 (25.0) |
≤ 2.0; Female | 18 (36.0) | 16 (33.3) |
> 2.0; Female | 16 (32.0) | 15 (31.3) |
Efficacy results
Mean (SE) | Differencea (95% CI) | % diffb. | p-value | ||
---|---|---|---|---|---|
SnF2 | Negative | ||||
Bleeding Index | |||||
Baseline | 0.30 (0.021) | 0.31 (0.027) | – | – | – |
Week 12 | 0.11 (0.017) | 0.23 (0.016) | −0.13 (− 0.17, − 0.08) | −54.6 | < 0.0001 |
Week 24 | 0.11 (0.013) | 0.19 (0.012) | − 0.07 (− 0.11, − 0.04) | −39.5 | < 0.0001 |
Bleeding Sites | |||||
Baseline | 28.93 (1.916) | 29.15 (2.223) | – | – | – |
Week 12 | 12.26 (1.596) | 23.92 (1.596) | −11.72 (−16.08, −7.35) | −48.9 | < 0.0001 |
Week 24 | 12.69 (1.562) | 20.19 (1.331) | −7.08 (−10.63, −3.53) | −35.4 | 0.0002 |
Modified Gingival Index | |||||
Baseline | 2.04 (0.024) | 2.03 (0.020) | – | – | – |
Week 12 | 1.42 (0.045) | 1.87 (0.042) | −0.45 (− 057, − 0.33) | −24.0 | < 0.0001 |
Week 24 | 1.45 (0.048) | 1.78 (0.045) | −0.33 (− 0.46, − 0.20) | −18.5 | < 0.0001 |
Plaque Index | |||||
Baseline | 3.17 (0.064) | 3.06 (0.065) | – | – | – |
Week 12 | 2.56 (0.053) | 2.93 (0.050) | −0.37 (− 0.51, − 0.22) | −12.5 | < 0.0001 |
Week 24 | 2.53 (0.057) | 2.86 (0.054) | −0.33 (− 0.48, − 0.17) | −11.4 | < 0.0001 |
Interproximal Plaque Index | |||||
Baseline | 3.29 (0.057) | 3.18 (0.060) | – | – | – |
Week 12 | 2.78 (0.045) | 3.08 (0.042) | −0.29 (− 0.42, − 0.17) | −9.6 | < 0.0001 |
Week 24 | 2.75 (0.050) | 3.02 (0.047) | −0.28 (− 0.42, − 0.14) | −9.2 | < 0.0001 |