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HGH クリスタルMD® の口腔内環境改善効果―非盲検前後比較試験―
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JPY
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.
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