Table 3.

GCF findings in SDD clinical trial over two years [35]

In the overall intent-to-treat analysis, SDD reduced median GCF collagenase activity by 22% compared to placebo (95% CI: 37% lower to 5% lower, p=0.01)

In the overall intent-to-treat sample, SDD reduced median GCF ICTP levels by 16% compared to placebo (p=0.08). However, when 3 extreme baseline values were deleted (2 values in the placebo group and 1 in the SDD group), SDD significantly reduced GCF ICTP by 19% compared to placebo (95% CI: 33% lower to 2% lower, p=0.03).

In the overall intent-to-treat sample, SDD significantly reduced the odds of elevated MMP-8 values (relative to placebo subjects) by 60% (OR=0.40, 95% CI: 0.21 to 0.77, p=0.006).

Collagenase activity and ICTP in the GCF were significantly and linearly related with positive correlation coefficients (r = 0.62, 0.52 and 0.50 for baseline, 1-year and 2-year time periods, respectively and all three r values were highly statistically significant [p < 0.001]). In general, the higher the values for GCF collagenase activity, the greater the level of bone collagen breakdown products (ICTP).

In subgroup analyses:

SDD reduced median IL-1β levels by 51% among subjects more than 5 years  postmenopausal (OR=0.49; 95% CI: 76% lower to 1% lower; p=0.05).