A randomized, double-blind, placebo-controlled multicenter study for evaluating the effects of fixed-dose combinations of vitamin C, vitamin E, lysozyme, and carbazochrome on gingival inflammation in chronic periodontitis patients.

BACKGROUND

To evaluate gingival inflammation from fixed-dose combinations of vitamin C, vitamin E, lysozyme and carbazochrome (CELC) in the treatment of chronic periodontitis following scaling and root planing.

METHODS

One hundred patients were randomly assigned to receive CELC (test) or placebo (control) for the first 4 weeks at a 1:1 ratio, and both groups received CELC for the remaining 4 weeks. Primary outcome was the mean change in the gingival index (GI) after 4 weeks. Secondary outcomes included mean change in GI after 8 weeks and plaque index, probing depth, clinical attachment level, and VAS at 4 weeks and 8 weeks.

RESULTS

Ninety-three patients completed the study. The GI in the test group significantly decreased after 4 weeks (p < 0.001) and 8 weeks (p < 0.001). The mean change from baseline in GI significantly decreased in the test group compared to the control group after 4 weeks (p = 0.015). In the GEE model adjusting for age, gender and visits, the test group showed 2.5 times GI improvement compared to the control group (p = 0.022).

CONCLUSIONS

Within the study, CELC showed a significant reduction in gingival inflammation compared with a placebo. Other parameters, however, were similar between groups.

TRIAL REGISTRATION

KCT0001366 (Clinical Research Information Service, Republic of Korea) and 29 Jan 2015, retrospectively registered.