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Randomized Controlled Trial
. 2019 Mar 7;19(1):40.
doi: 10.1186/s12903-019-0728-2.

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

Ji-Youn Hong  1 , Jung-Seok Lee  2 , Seong-Ho Choi  2 , Hyun-Seung Shin  3 , Jung-Chul Park  3 , Seung-Il Shin  4 , Jong-Hyuk Chung  5
Affiliations
Randomized Controlled Trial

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

Ji-Youn Hong et al. BMC Oral Health. .

Abstract

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.

Keywords: Carbazochrome; Lysozyme; Periodontitis; Vitamin C; Vitamin E.

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Conflict of interest statement

Ethics approval and consent to participate

This study adhered to CONSORT guidelines and was conducted in accordance with the World Medical Association Helsinki Declaration (Version 2008). The study protocol was approved by each of the involved Institutional Review Boards (IRBs) at Kyung Hee University Dental Hospital (KHDIRB1409–2), Yonsei University Hospital (2014–0074), and Dankook University Hospital (H-1411/011/003). All the participants were informed of the objectives, interventions, and possible risks and benefits of the study prior to enrollment, and written consent was obtained.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Flow chart of the clinical study
See this image and copyright information in PMC

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