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イオン放出性コーティング材を用いたう蝕予防の可能性：無作為化臨床試験
Opportunities for caries prevention using an ion-releasing coating material: a randomised clinical study.
PMID: 32888115 DOI: 10.1007/s10266-020-00551-7.
抄録
イオン放出性材料（例えばフッ化物やホウ素を含む）は，in vitroで齲蝕予防効果を示している．本研究の目的は，マルチイオン放出性コーティング材のpH安定化，プラーク蓄積，歯垢の細菌組成に及ぼす影響を90日間の期間にわたって調査することであった．本研究は、28名のボランティアを対象とした二重盲検、口唇分割、無作為化、対照臨床試験として実施された。評価期間中（4日目、30日目、60日目、90日目）に、pH測定、プラーク指数、細菌分析のためのプラークサンプリングを校正された標準化された方法で実施した。本研究は倫理的許可を得て、ヘルシンキ宣言に基づいて実施された。プラーク蓄積に関する帰無仮説は棄却され，60-90日までのプラーク指数は試験群の方が低いことが示された。また，観察期間中の副作用は認められなかった。研究対象となったコホートはう蝕の観点からは健康であったため，他の患者群におけるイオン放出性物質のう蝕予防効果をさらに評価するためには，より多くの臨床研究が必要である．
Ion-releasing materials (containing fluoride and boron, for example) have shown caries-preventive effects in vitro. The purpose of the present study was to investigate the impact of multi-ion-releasing coating material on pH stabilisation, plaque accumulation and the bacterial composition of dental plaque during a time period of 90 days. The null hypothesis tested here was that the evaluated material would not show any differences in pH stabilisation, plaque accumulation or bacterial composition compared with control material.The study was carried out as a double-blind, split-mouth, randomised, controlled clinical trial in 28 volunteers. Over the evaluation period (days 4, 30, 60 and 90), pH measurements, plaque index and plaque sampling for bacterial analyses were conducted in a calibrated, standardized manner. The study received ethical permission and was carried out in accordance with the Helsinki Declaration.A significant difference was observed, with less plaque accumulation over time in the subjects in whom the ion-releasing material was applied in comparison to the non-active group. No significant difference was evident in terms of either pH stabilisation or plaque levels of mutans streptococci.The null hypothesis relating to plaque accumulation was rejected, with a lower plaque index shown for the test group up to 60-90 days. No adverse effects during the observation period were observed. Since the studied cohort was healthy from a caries perspective, more clinical studies are needed to further evaluate the caries-prevention potential of the ion-releasing material in other patient groups.