Tonetti Maurizio S, Cortellini Pierpaolo, Bonaccini Daniele, Deng Ke, Cairo Francesco, Allegri Mario, Conforti Gianpaolo, Graziani Filippo, Guerrero Adrian, Halben Jan, Malet Jacques, Rasperini Giulio, Topoll Heinz
Department of Oral and Maxillofacial Implantology, Shanghai Key Laboratory of Stomatology, National Clinical Research Centre for Stomatology, Shanghai Ninth People Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
European Research Group on Periodontology, Genova, Italy.
J Clin Periodontol. 2021 Jul;48(7):962-969. doi: 10.1111/jcpe.13466. Epub 2021 May 6.
To report the 36-month follow-up of a trial comparing the adjunct of a xenogenic collagen matrix (CMX) or connective tissue graft (CTG) to coronally advanced flaps (CAF) for coverage of multiple adjacent recessions.
125 subjects (61 CMX) with 307 recessions in 8 centres from the parent trial were followed-up for 36 months. Primary outcome was change in position of the gingival margin. Multilevel analysis used centre, subject and tooth as levels and baseline parameters as covariates.
No differences were observed between the randomized and the follow-up population. Average baseline recession was 2.6 ± 1.0 mm. 3-year root coverage was 1.5 ± 1.5 mm for CMX and 2.0 ± 1.0 mm for CTG (difference of 0.32 mm, 95% CI from -0.02 to 0.65 mm). The upper limit of the confidence interval was over the non-inferiority margin of 0.25 mm. No treatment differences in position of the gingival margin were observed between 6- and 36-month follow-up (difference 0.06 mm, 95% CI -0.17 to 0.29 mm).
CMX was not non-inferior with respect to CTG in multiple adjacent recessions. No differences in stability of root coverage were observed between groups and in changes from 6 to 36 months. Previously reported shorter time to recovery, lower morbidity and more natural appearance of tissue texture and contour observed for CMX in this trial are also relevant in clinical decision-making.
报告一项试验的36个月随访结果,该试验比较了将异种胶原基质(CMX)或结缔组织移植物(CTG)与冠向复位瓣(CAF)联合用于覆盖多个相邻牙龈退缩的效果。
来自母试验的8个中心的125名受试者(61名使用CMX),共307处牙龈退缩,进行了36个月的随访。主要结局是牙龈边缘位置的变化。多水平分析将中心、受试者和牙齿作为分析水平,并将基线参数作为协变量。
随机分组人群和随访人群之间未观察到差异。平均基线退缩为2.6±1.0毫米。CMX组3年牙根覆盖为1.5±1.5毫米,CTG组为2.0±1.0毫米(差异为0.32毫米,95%置信区间为-0.02至0.65毫米)。置信区间的上限超过了非劣效性界值0.25毫米。6个月和36个月随访时,牙龈边缘位置在治疗上无差异(差异为0.06毫米,95%置信区间为-0.17至0.29毫米)。
在多个相邻牙龈退缩方面,CMX相对于CTG并非非劣效。两组在牙根覆盖稳定性以及6至36个月的变化方面均未观察到差异。本试验中先前报道的CMX恢复时间更短、发病率更低以及组织质地和轮廓外观更自然等结果,在临床决策中也具有相关性。