6～7歳の学童における亜酸性1%NaF-HFゲルのう蝕予防効果：無作為化比較試験

Preventive effect of subacidic 1% NaF-HF gel on dental caries in 6- to 7-year-old schoolchildren: a randomized controlled trial.

• Ki-Ho Rim
• Myong-Chol Jong
• Chol-Jun Hwang
• Chol-Ho Kim
• Pyong-Tae Nam
• Sun-Yong Choe

抄録

<p>目的。本研究は、6～7歳児の下顎第一大臼歯に微酸性1%NaF-HFゲルを1回または2回（7日または6ヶ月間隔）塗布した場合のう蝕予防効果を検討・比較することを目的とした。方法と材料。1年間の多群、プラセボ対照、二重盲検、並行群無作為化試験であった。8つの小学校の合計1,077人の学童が、4つの試験群（第1群は単回塗布、第2群は7日間隔で2回塗布、第3群は6ヶ月間隔で2回塗布、第4群はプラセボ対照）のいずれかに割り付けられた。永久下顎第一大臼歯の咬合面は、ベースライン時と試験終了時に、3人の検量線を持った検者がグループの割り付けを盲検化して検査した。<br /> 結果。また、平均D2MFT増分（第1群0.22、第2群0.06、第3群0.18、対照群0.50）も群間で統計的に有意な差を示した（P<.001）。<br /> <br /> <br /> 結論：亜酸性1%NaF-HFゲルは、飲料水がフッ素化されていない地域でフッ化物歯磨き粉を使用していない6～7歳の学童に7日間隔で2回塗布した場合、う蝕に対して高い予防効果（40%以上）を発揮することがわかった。

<p>Objective: This study aimed to examine and compare the anti-caries effects of slightly acidic 1% NaF-HF gel when applied once or twice (7-day or 6-month interval) to mandibular first molars in 6- to 7-year-old children. Method and materials: This was a 1-year, multi-arm, placebo-controlled, double-blind, parallel-group randomized trial. In total, 1,077 schoolchildren from eight primary schools were allocated to one of the four study groups (group 1, single application; group 2, two applications with a 7-day interval; group 3, two applications with a 6-month interval; group 4, placebo control). The occlusal surfaces of permanent mandibular first molars were examined by three calibrated examiners who were blind to the group allocation at baseline and the end of the study. Caries reduction and prevented fraction was assessed.<br /> Results: A total of 986 children completed the study. There was a statistically significant difference in the mean D1MFT increment across the groups (P &lt; .001). The mean D1MFT increment was 0.37 in group 1 (single application), 0.18 in group 2 (two applications with a 7-day interval), 0.21 in group 3 (two applications with a 6-month interval), and 0.56 in the control group. The mean D2MFT increments (0.22 in group 1, 0.06 in group 2, 0.18 in group 3, and 0.50 in the control group) also showed a statistically significant difference across the groups (P &lt; .001).<br /> Conclusion: Subacidic 1% NaF-HF gel exerts a high preventive effect on caries (more than 40%) when applied twice at a 7-day interval in 6- to 7-year-old schoolchildren who do not use fluoride toothpaste in areas where drinking water is not fluoridated.</p>.