多変量解析により明らかになった総義歯装着者の義歯接着剤使用時の口腔健康関連QOL：多施設共同無作為化比較試験

Multivariate analysis reveals oral health-related quality of life of complete denture wearers with denture adhesives: a multicenter randomized controlled trial.

抄録

目的 10施設並行無作為化臨床試験において、総義歯装着者の口腔内および義歯の状態による、クリームタイプまたはパウダータイプの義歯床用接着剤を使用した場合の口腔保健関連QOL（OHR-QoL）の改善度の違いを検討する。方法 総義歯を装着している無歯顎被験者200名を、義歯床用接着剤のタイプ別にクリーム、パウダー、コントロール（生理食塩水）の3群に割り付けた。それぞれの材料を義歯の粘膜表面に4日間塗布し、ベースラインデータと介入後のデータを収集した。OHR-QoLは、OHIP-EDENT-J（Oral Health Impact Profile for Edentulous Patients）を用いて評価した。結果 OHIP-EDENT-Jスコアは介入後すべての群で有意に低下した（p＜0.05）が、群間に統計学的有意差は認められなかった。多重ロジスティック回帰分析の結果、クリームタイプの義歯床用接着剤群では、上顎および下顎歯槽骨隆起の垂直高さとOHIP-EDENT-Jスコアとの間に有意な関連が認められた。結論 義歯床用接着剤の使用は、総義歯装着者のOHR-QoLを改善する可能性がある。クリームタイプの義歯床用接着剤は、良好な残存咬合状態の患者と比較して、残存咬合状態の悪い患者のOHR-QoLを改善することが期待される。

Purpose To investigate the difference in improvement of oral health-related quality of life (OHR-QoL) depending on the oral and denture conditions of a complete denture wearer when using a cream or powder type denture adhesive in a 10-center parallel randomized clinical trial.Methods Two hundred edentulous subjects who wore complete dentures were allocated to each of the three groups according to denture adhesive type: cream, powder, and control (saline solution). The materials were applied to the mucosal surface of the dentures for 4 days, and baseline data and data after the intervention were collected. OHR-QoL was assessed using the Japanese version of the modified Oral Health Impact Profile for Edentulous Patients (OHIP-EDENT-J) scale for outcome. Multivariate analysis was used to investigate improvements in OHR-QoL according to participant characteristics among complete denture wearers using these materials.Results OHIP-EDENT-J scores were significantly decreased in all groups after the intervention (p < 0.05); however, there were no statistically significant differences among the groups. Multiple logistic regression analysis revealed a significant association between the vertical height of the maxillary and mandibular alveolar ridge and OHIP-EDENT-J scores in the cream-type denture adhesive group. In contrast, there were no significant association between participant characteristics and OHIP-EDENT-J scores in the powder-type adhesive and control groups.Conclusions The use of denture adhesives could improve OHR-QoL for complete denture wearers. The cream-type denture adhesives may be expected to improve OHR-QoL in patients with poor residual ridge conditions compared with patients with good residual ridge conditions.