Department of Periodontology, Universitat Internacional de Catalunya, Barcelona, Spain.
Clin Oral Implants Res. 2022 Jun;33 Suppl 23:72-99. doi: 10.1111/clr.13920.
The first focused question (FQ1) was: What is the efficacy of connective tissue graft (CTG), as compared to the absence of soft tissue grafting procedure, in terms of gain in peri-implant soft tissue thickness (STT) reported by randomized controlled clinical trials (RCTs) or controlled clinical trials (CCTs)? The second focused question (FQ2) was: What is the efficacy of CTG, as compared to soft tissue substitutes, in terms of gain in peri-implant STT reported by RCTs or CCTs?
A manual and electronic search was performed for each question to identify RCTs and CCTs published up to July 2020. The primary outcome variable was changes in peri-implant STT and secondary outcomes were marginal bone level (MBL), clinical parameters for the diagnosis of peri-implant health, changes in the position of peri-implant soft tissues, esthetic outcomes, and patient-related outcome measures (PROMs). For primary and secondary outcomes, data reporting mean values and standard deviations for each study were extracted. Weighted mean differences (WMDs) or standardized mean differences as well as 95% confidence intervals (CIs) and prediction intervals (PIs) were calculated.
Eight trials were included to answer the first focused question and eight to answer the second one, providing data for 254 and 192 patients, respectively. For the first focused question, a statistically significant difference of 0.64 mm in STT was found in favor of the grafted group (n = 8; 95% CI [0.16; 1.13]; 95% PI [-1.06; 2.35]; p = .01). Moreover, sites treated with CTG exhibited statistically significant less recession than implants without a graft (n = 4; WMD = 0.50 mm; 95% CI [0.19; 0.80]; 95% PI [-0.70; 1.69]; p < .001). For the second focused question, the meta-analysis showed a statistically significant gain of STT in the CTG group when compared to soft tissue substitutes (n = 8; WMD = 0.51 mm; 95% CI [0.28; 0.75]; 95% PI [-0.09; 1.12]; p < .001). Furthermore, the use of CTG resulted in significantly higher pink esthetic score values (n = 3; WMD = 1.02; 95% CI [0.29; 1.74]; 95% PI [-3.67; 5.70]; p = .01) and less recession (n = 2; WMD = 0.50 mm; 95% CI [0.10; 0.89]; 95% PI [not estimable]; p = .014) when compared to soft tissue substitutes. No statistically significant differences between groups were observed for any of the following secondary variables: MBL, clinical parameters for the diagnosis of peri-implant health, position of the interproximal tissues, keratinized mucosa or PROMS (p > 0.05), except for medication intake, which was significantly higher when using CTG as compared to soft tissue substitutes (n = 2; WMD = 1.68; 95% CI [1.30; 2.07]; 95% PI [not estimable]; p < .001).
Soft tissue augmentation procedures are efficacious on soft tissue thickening and, in particular, CTG demonstrated a significant STT gain when compared to no graft or soft tissue substitutes.
第一个聚焦问题(FQ1)是:与不进行软组织移植手术相比,在随机对照临床试验(RCTs)或对照临床试验(CCTs)报告的种植体周围软组织厚度(STT)增加方面,结缔组织移植物(CTG)的疗效如何?第二个聚焦问题(FQ2)是:与软组织替代物相比,CTG 在 RCTs 或 CCTs 报告的种植体周围 STT 增加方面的疗效如何?
针对每个问题进行了手动和电子搜索,以确定截至 2020 年 7 月发表的 RCTs 和 CCTs。主要结局变量是种植体周围 STT 的变化,次要结局变量是边缘骨水平(MBL)、种植体周围健康诊断的临床参数、种植体周围软组织位置的变化、美学结局和患者相关结局测量(PROMs)。对于主要和次要结局,提取了每个研究报告的均值和标准差的数据。计算了加权均数差异(WMDs)或标准化均数差异以及 95%置信区间(CIs)和预测区间(PIs)。
为了回答第一个聚焦问题,纳入了 8 项试验,为回答第二个聚焦问题,纳入了 8 项试验,分别为 254 名和 192 名患者提供了数据。对于第一个聚焦问题,发现移植组在 STT 方面有统计学意义的 0.64mm 优势(n=8;95%CI [0.16;1.13];95%PI [-1.06;2.35];p=0.01)。此外,与未接受移植的种植体相比,接受 CTG 治疗的部位发生牙龈退缩的风险明显降低(n=4;WMD=0.50mm;95%CI [0.19;0.80];95%PI [-0.70;1.69];p<0.001)。对于第二个聚焦问题,meta 分析显示,与软组织替代物相比,CTG 组在 STT 方面有统计学意义的增加(n=8;WMD=0.51mm;95%CI [0.28;0.75];95%PI [-0.09;1.12];p<0.001)。此外,与软组织替代物相比,使用 CTG 可显著提高粉红色美学评分值(n=3;WMD=1.02;95%CI [0.29;1.74];95%PI [-3.67;5.70];p=0.01)和减少牙龈退缩(n=2;WMD=0.50mm;95%CI [0.10;0.89];95%PI [不可估计];p=0.014)。在任何次要变量(MBL、种植体周围健康诊断的临床参数、邻间组织位置、角化黏膜或 PROMs)中,各组之间均未观察到统计学意义上的差异(p>0.05),但药物摄入除外,与软组织替代物相比,使用 CTG 时药物摄入明显更高(n=2;WMD=1.68;95%CI [1.30;2.07];95%PI [不可估计];p<0.001)。
软组织增强程序在软组织增厚方面是有效的,特别是 CTG 与不进行移植或软组织替代物相比,在种植体周围 STT 增加方面表现出显著的疗效。