光动力疗法对牙周炎磨牙拔牙窝愈合影响的随机对照优效性临床试验

Healing effect of photodynamic therapy on extraction sockets of periodontally compromised teeth:a randomized,controlled,superiority clinical trial

目的评估光动力疗法(PDT)对牙周炎磨牙拔牙窝软组织愈合、拔牙后疼痛度、影像学骨密度和骨高度改变的影响。方法本研究为一项单中心单盲随机对照优效性临床试验,共纳入2022年12月至2023年9月在浙江大学医学院附属口腔医院牙周科就诊患者需要拔除的38个牙周炎磨牙位点,按照简单随机方法分为PDT组和对照组,每组19个位点,PDT组拔牙后常规清创并辅助使用PDT,对照组拔牙后仅常规清创。在拔牙后即刻、7 d、14 d分别测定两组拔牙窝颊舌径及近远中径并计算7和14 d创面愈合率,在拔牙后7和14 d评估两组拔牙窝软组织愈合指数,使用视觉模拟评分法评估两组拔牙后6 h和1、2、3 d时的疼痛度,在拔牙后即刻和2个月拍摄根尖片比较两组拔牙窝骨密度及骨高度的变化,并进行统计学分析。结果拔牙后7 d创面愈合率PDT组[(78.08±5.45)%]显著高于对照组[(71.03±6.82)%](P<0.01),拔牙后14 d创面愈合率PDT组[(85.88±3.84)%]亦显著高于对照组[(81.66±3.79)%](P<0.01),但均未达到优效性检验的优效界值(优效界值为10%,7 d 95%CI:3.00%~11.12%,14 d 95%CI:1.71%~6.73%)。拔牙后7 d拔牙窝软组织愈合指数PDT组显著高于对照组(P<0.05),拔牙后14 d拔牙窝软组织愈合指数两组间差异无统计学意义(P>0.05)。拔牙后6 h及1、2、3 d时的疼痛度以及拔牙后即刻和2个月骨密度、骨高度改变量两组间差异均无统计学意义(均P>0.05)。结论PDT在一定程度上能促进软组织愈合,但对牙周炎患者拔牙窝的愈合未起到额外的辅助作用,对拔牙术后疼痛度、影像学骨密度和骨高度改变等无显著影响。

ObjectiveTo evaluate the effects of photodynamic therapy(PDT)in extraction sockets of periodontally compromised molars on soft tissue healing,postoperative pain,bone density and bone height changes.MethodsThis study is a single-center,single-blind,randomized controlled superiority clinical trial.Thirty-eight periodontally compromised molars requiring extraction in patients attending the Department of Periodontology,Stomatology Hospital,School of Stomatology,Zhejiang University School of Medicine,from December 2022 to September 2023 were included,and randomly assigned to PDT group and control group.The control group received routine debridement after extraction,while PDT group received routine debridement followed by PDT.The bucco-lingual and mesio-distal wound distances at 7 and 14 d after extraction were measured,and then the wound closure rates were calculated.Evaluating the soft tissue healing indexes at 7 and 14 d after extraction.The visual analogue scale was used to assess the pain level at 6 h,1 d,2 d,and 3 d after tooth extraction.Apical radiographs were taken immediately and 2 months after extraction in order to compare the changes of the bone density and height.ResultsThe wound closure rate at 1 week was(78.08±5.45)%in PDT group and(71.03±6.82)%in control group,with significant differences(P<0.01).The wound closure rate at 2 weeks in PDT group[(85.88±3.84)%]was significantly higher than that in the control group[(81.66±3.79)%](P<0.01),but did not reach the superiority value of the superiority test(superiority value=10%,95%CI at 1 week:3.00%-11.12%,95%CI at 2 weeks:1.71%-6.73%).The soft tissue healing index of PDT group at 1 week was significantly better than the control group(P<0.05),but there was no significant difference between the two groups at 2 weeks(P>0.05).There was no significant difference between the two groups in terms of postoperative pain at 6 h,1 d,2 d and 3 d as well as in bone density and height changes at 2 months after tooth extraction(P>0.05).ConclusionsPDT could promote soft tissues healing to some extent,but did not provide additional assistance in the healing of extraction sockets of periodontally compromised teeth.PDT did not show benefits on postoperative pain,changes of the bone density and bone height after tooth extraction.