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

Abstract

BackgroundTo 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.MethodsOne hundred patients were randomly assigned to receive CELC (test) or placebo (control) for the first 4weeks at a 1:1 ratio, and both groups received CELC for the remaining 4weeks. Primary outcome was the mean change in the gingival index (GI) after 4weeks. Secondary outcomes included mean change in GI after 8weeks and plaque index, probing depth, clinical attachment level, and VAS at 4weeks and 8weeks.ResultsNinety-three patients completed the study. The GI in the test group significantly decreased after 4weeks (p<0.001) and 8weeks (p<0.001). The mean change from baseline in GI significantly decreased in the test group compared to the control group after 4weeks (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).ConclusionsWithin the study, CELC showed a significant reduction in gingival inflammation compared with a placebo. Other parameters, however, were similar between groups.Trial registrationKCT0001366 (Clinical Research Information Service, Republic of Korea) and 29 Jan 2015, retrospectively registered.