Sodium hypochlorite應用於人類乳臼齒冠髓切除術之臨床研究

Abstract

本研究為2.5% NaOCl與傳統DFC乳臼齒冠髓切除術的前瞻性隨機臨床試驗，目的為探討2.5% NaOCl是否可取代DFC，作為乳臼齒冠髓切除術的材料；本研究納入的受試者年齡最小為2.7歲，最大為8.3歲，最初共有150顆乳臼齒納入試驗，隨機分配至控制組(DFC)或是實驗組(2.5% NaOCl)來進行治療；在治療完成後的3、6、9、12、15及18個月，由獨立的評估者進行盲性臨床檢查及X光檢查的判讀，將收集到的分類資料，在p值小於0.05視為統計顯著的前提下，以卡方檢定(chi-square test)、費雪正確機率考驗(Fisher exact test)及獨立樣本t檢定 (Independent t-tesst)等統計分析，藉以比較不同追蹤時間間隔的兩組之間的治療成功率；並以次序迴歸及多項式回歸統計分析，來探討兩材料及其他變數(年齡、齒位及操作醫師等)對放射線學分數的影響；統計結果顯示2.5% NaOCl與DFC臨床成功率皆為100%，放射線學成功率分別為94.1%到96.8%，及94.1%到98.2%，2.5% NaOCl與DFC組的成功率在統計上沒有顯著差異，並且在放射線學上的各項發現上(根管鈣化、牙根內吸收、牙根外吸收及牙根周圍病變等)亦無統計上的顯著差異；而多項式迴歸分析亦指出兩材料對放射線學分數沒有顯著影響，但年齡及上下牙弓位置則會影響放射學評分。基於本研究的結果以及 對DFC毒性的疑慮，我們認為2.5% NaOCl可以替代DFC做為臨床上冠髓切除術的材料，而期待未來有更多的臨床長期追蹤及組織學上進一步的研究做為佐證。

This study is a prospective clinical randomized controlled trial of 2.5% NaOCl pulpotomy and DFC pulpotomy. The aim of this sudy is to determining weather NaOCl is a suitable replacement for FC in the pulpotomy of human primary molar teeth. This study included 82 children from 2.7 to 8.3 year-old. 150 primary molars were randomly assigned to the control group (dilute 20% Formocresol (DFC)) or experimental group (2.5% NaOCl). At 3, 6, 9, 12, 15 and 18 months post-treatment,these teeth were clinically and radiographically evaluated by blinded independent evaluators. The differences will be statistically analyzed using chi-square test, Fisher exact test, and independent t-test, using a statistical significance at p<0.05. Moreover, ordinal logistic regression and multinomial logistic regression test were performed to evaluate whether pulpotomy material and other variables such as age, gender, tooth position and operator would influence the radiographic scoring. The control (DFC) and experimental (2.5% NaOCl) groups both demonstrated 100% clinical success. Furthermore, the NaOCl group had 94.1% to 96.8% and the FC group had 94.1% to 98.2% radiographic success rate. No significant differences were found in the radiographic success rate or specific radiographic finding (ex: PCO, IRR, ERR, or PRL etc) between the two groups. Multinomial logistic regression test showed the two pulpotomy material had no siginificant influence on radiographic scoring, however, age and arch had some effect on radiographic scoring. Based on the result of this clinical study and the concern about the toxicity of FC, we suggesting that NaOCl may be an appropriate substitute for FC.