フッ素ゲルによる非う蝕活動性病変の阻止効果：無作為化臨床試験．

Efficacy of fluoride gel in arresting active non-cavitated caries lesions: a randomized clinical trial.

抄録

本研究は，永久歯の非う蝕活動性病変を阻止するためのフッ化物ゲルの有効性を評価した．この無作為化三重盲検プラセボ対照臨床試験は，10.7±2.2 歳の学童 100 名を試験治療（1.23%酸性リン酸フッ化物 [APF] ゲル）または対照治療（プラセボゲル）に無作為化し，週間隔で 4-6 回適用した．データ収集は，可視プラーク指数，歯肉出血指数，咬合面の可視プラーク蓄積量，萌出期，う蝕を行った．グループと病変停止との関連はロジスティック回帰で評価し，推定値はベースライン時の病変上のプラーク蓄積，表面タイプ，歯のタイプで調整した．モデルは、データのクラスタリング（すなわち、同一人物が1つ以上の病変をもたらした）を考慮した一般化推定方程式を使用して適合させた。98人の小児が試験を完了した（フッ化物48人、プラセボ50人）。すべての歯面を分析したところ、病変が停止する可能性は両群間で同等であった（p > 0.05）。臼歯部の咬合病変のみを対象とした二次解析では，萌出中の歯では，1.23％APFゲルを投与した病変はプラセボゲルを投与した病変に比べて約3倍の確率で停止した（OR = 2.85; 95％CI = 1.23-6.61; p = 0.01 ）．萌出が完了した臼歯部では有意差は認められなかった（p＞0.05）．フッ素ゲルによる非う蝕病変の阻止の効果は，この短期間の試験では臨床的評価によって確認することができなかった．しかし，萌出臼歯の咬合面のようにう蝕原性が高い場合には，1.23％APFゲルによるう蝕対策は重要な手段であった．

This study evaluated the efficacy of fluoride gel in arresting active non-cavitated caries lesions in permanent teeth. This randomized, triple-blind, placebo-controlled clinical trial randomized 100 schoolchildren aged 10.7 ± 2.2 years to test treatment (1.23% acidulated phosphate fluoride [APF] gel) or control treatment (placebo gel) for 4-6 applications at weekly intervals. Data collection included the visible plaque index, gingival bleeding index, visible plaque accumulation on the occlusal surfaces, eruption stage, and dental caries. The association between group and lesion arrestment was assessed using logistic regression, and estimates were adjusted for plaque accumulation over the lesion at baseline, surface type, and tooth type. Models were fitted using generalized estimating equations for accounting for the clustering of data (i.e., the same individual contributed > 1 lesion). Ninety-eight children completed the study (48 fluoride and 50 placebo). When all dental surfaces were analyzed, the likelihood of lesion arrestment was similar between both groups (p > 0.05). A secondary analysis including only the occlusal lesions in molars showed that for teeth under eruption, lesions receiving the 1.23% APF gel were about 3-fold more likely to become arrested than lesions receiving the placebo gel (OR = 2.85; 95%CI = 1.23-6.61; p = 0.01). No significant difference was detected for molars with complete eruption (p > 0.05). The benefit of fluoride gel for arresting non-cavitated caries lesions could not be identified by clinical assessment in this short-term trial. Notwithstanding, when the cariogenic challenge was greater (as on the occlusal surfaces of erupting molars), 1.23% APF gel treatment was an important tool for caries control.