固定式矯正歯科治療中のホワイトスポット病変の予防における酸性リン酸塩フッ化物（APF）と中性フッ化ナトリウム（NaF）洗口液の臨床的有用性に関する広範な比較検討．無作為化比較試験

An Extensive Comparison of the Clinical Efficiency of Acidulated Phosphate Fluoride (APF) and Neutral Sodium Fluoride (NaF) Oral Rinses in the Prevention of White Spot Lesions during Fixed Orthodontic Treatment: A Randomized Controlled Trial.

抄録

背景:

本無作為化試験の目的は、固定式矯正装置治療に伴う白色斑病変（WSL）の減少における中性フッ化ナトリウム（NaF）洗口液の週 1 回投与法と酸性リン酸塩（APF）製剤による毎日の洗口液の有効性を比較検討することである。

Background: The purpose of this randomized trial is to compare the efficacy of weekly once regime of neutral sodium fluoride (NaF) oral rinse with that of acidulated phosphate (APF) formulated daily mouth rinse in the reduction of white spot lesions (WSLs) associated with fixed orthodontic appliance treatment.

研究方法:

対照群を設定しない単一施設2群並行試験において，ブラケット接着後の被験者を1：1の割合で2群に無作為に割り付けた。A群/試験群1（＝45）には中性フッ化ナトリウム（0.2％NaF）を週1回，B群/試験群2（＝45）にはAPF製剤（-0.044％w/v of NaF）を6ヵ月間毎日口腔洗浄液として投与した．脱灰のスコアリングには国際齲蝕検知評価システム（ICDAS）インデックスを、歯肉炎のスコアリングにはLoe and Silness歯肉指標（GI）を用いた。ICDASとGIは、ボンディング直前のT0、4週間後のT1、12週間後のT2、24週間後のT3の4つの時点において評価した。

Methods: The participants ( = 90) of this single-center, two-arm parallel study without a control group were randomly assigned with 1 : 1 distribution to each of the two groups after the bonding of brackets. Group A/test group 1 ( = 45) was given weekly rinse of neutral sodium fluoride (0.2% NaF), and for group B/test group 2 ( = 45), an APF formulated daily oral rinse (-0.044% w/v of NaF) was given for six months. The outcome was assessed by the International Caries Detection and Assessment System (ICDAS) index for scoring the demineralization, and for scoring gingivitis, Loe and Silness gingival index (GI) was utilized. Four different time points "T0"immediately before bonding procedures, "T1" after 4weeks, "T2" after 12 weeks, and "T3" after 24 weeks were taken to assess the ICDAS and GI scores.

結果:

A群（NaF）の平均ICDASスコアは0.025、0.051、0.093、0.113、B群（APF）は0.014、0.022、0.038、0.015で、異なる時期であった。GIスコアは、A群では0.008、0.22、0.33、0.38、B群では0.003、0.136、0.181、0.097であり、異なる時点のものであった。WSLとGIの減少に関して、両群で統計的に有意な差（< 0.05）があった。

Results: The mean ICDAS scores for group A (NaF) were 0.025, 0.051, 0.093, and 0.113 and for group B (APF) were 0.014, 0.022, 0.038, and 0.015 at different points of time. The GI scores for group A were 0.008, 0.22, 0.33, and 0.38 and for group B were 0.003, 0.136, 0.181, and 0.097 at different time points. There was a statistically significant difference ( < 0.05) for both groups in terms of reducing WSL and GI.

結論:

APF製剤（0.044％w/v NaF）の毎日の洗口は，0.2％NaFの週1回の洗口よりも白点病変の予防に効果的であった．

Conclusion: APF formulated daily oral rinse-0.044% w/v of NaF-is more effective than the weekly once regimen of 0.2% NaF oral rinse to prevent white spot lesions.