薬理と治療

Abstract

Objective　We aimed to investigate the improvement of the oral environment in healthy Japanese adults following ingestion of HGH crystal MD®. Methods　Two open︱label comparative studies were conducted in November 2018（preliminary trial）and March 2019（main trial）in healthy Japanese adults who were not aware of dental caries（n＝11, n＝27, respectively）. HGH crystal MD was taken orally 3 times daily； the intervention period was 1 week（preliminary trial）and 4 weeks（main trial）. Assessments of periodontal disease︱related bacteria, evaluation of subjective symptoms, peripheral hematology tests, and oral examinations were performed before and 1 week（preliminary trial）or 4 weeks（main trial）after the ingestion of HGH crystal MD®. Safety was monitored throughout. Results　Eleven participants for the preliminary trial and 25 participants for the main trial were included in the analysis. In both trials, Tannerella forsythensis, a periodontopathy-related red-complex bacterium, was significantly decreased after ingestion compared with before ingestion（P＜0.05）. Subjective symptom evaluation showed significant improvements in oral odor, gum swelling, tooth roughness, mouth discomfort, mouth dryness, and stickiness in both trials（P＜0.05）. No subjects experienced any change in caries progression during the study, and no ingestionassociated adverse events were observed. Conclusions　HGH crystal MD® significantly decreased T. forsythensis, improved subjective oral cavity symptoms, and was found to be safe for the treatment of periodontal disease in this group of patients. Trial registration　UMIN-CTR: UMIN000034948（preliminary trial）, UMIN000035393（main trial） Foundation　Autobahn Co. Ltd.