比较两种脱细胞真皮基质厚度的结缔组织移植在改良前庭切口骨膜下隧道入路手术治疗牙龈退缩中的效果：一项探索性随机对照试验。

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中文摘要

目的： 在改良前庭切口骨膜下隧道入路手术中，比较结缔组织移植与厚、薄脱细胞真皮基质，以术后18个月选定目标位点的牙龈厚度作为主要终点。方法：在这项单中心探索性随机试验中，36名患有1型牙龈退缩的成年人按1:1:1比例分配至结缔组织移植组、厚脱细胞真皮基质组（1.0-1.2 mm）和薄脱细胞真皮基质组（0.4-0.6 mm）。纵向连续结局采用线性混合模型分析。18个月时的两两比较采用Welch检验，并进行结局内Bonferroni校正。术后视觉模拟量表疼痛评分和Landry愈合评分采用非参数方法分析。缺失数据情景和双单侧检验为事后分析。结果：在评估的47名个体中，11名被排除，36名被随机分组（每组12名）；35名患者有18个月主要终点数据。结缔组织移植组的平均（标准差）牙龈厚度为1.708（0.334）mm，厚脱细胞真皮基质组为1.708（0.450）mm，薄脱细胞真皮基质组为1.273（0.410）mm。结缔组织移植组的平均牙龈厚度比薄脱细胞真皮基质组多0.436 mm（95%置信区间：0.108至0.763；校正后p=0.036）；厚脱细胞真皮基质组与薄脱细胞真皮基质组之间的牙龈厚度差异在校正后无统计学意义（校正后p=0.073）。结缔组织移植组和厚脱细胞真皮基质组观察到的均值相当；然而，该试验的效能不足以证明等效性。两个脱细胞真皮基质组的术后视觉模拟量表评分均低于结缔组织移植组，且薄脱细胞真皮基质组第7天愈合评分高于厚脱细胞真皮基质组。结论：经多重校正后，结缔组织移植组18个月牙龈厚度大于薄脱细胞真皮基质组，而结缔组织移植组和厚脱细胞真皮基质组的均值相当。该研究未确立等效性，且根面覆盖估计值过于不精确，无法证明可比性。脱细胞真皮基质避免了腭部供区采集，并与较低的术后视觉模拟量表疼痛评分相关。试验注册：中国临床试验注册中心（WHO一级注册机构），ChiCTR2600124861。

英文摘要

ObjectiveTo compare connective tissue graft with thick and thin acellular dermal matrices in a modified vestibular incision subperiosteal tunnel access-based procedure, using gingival thickness at the selected target site 18 months postoperatively as the primary endpoint.MethodsIn this single-center exploratory randomized trial, 36 adults with recession type 1 gingival recession were allocated in a 1:1:1 ratio to connective tissue graft, thick acellular dermal matrices (1.0-1.2 mm), and thin acellular dermal matrices (0.4-0.6 mm) groups. Longitudinal continuous outcomes were analyzed using linear mixed models. Pairwise comparisions at 18 months were performed using Welch tests with within-outcome Bonferroni adjustment. Postoperative visual analogue scale pain scores and Landry healing scores were analyzed nonparametrically. Missing-data scenarios and two one-sided tests were post hoc.ResultsAmong the 47 individuals assessed, 11 were excluded and 36 were randomized (12 per group); 18-month primary-endpoint data were available for 35 patients. The mean (SD) gingival thickness was 1.708 (0.334) mm in the connective tissue graft group, 1.708 (0.450) mm in the thick acellular dermal matrices group, and 1.273 (0.410) mm in the thin acellular dermal matrices group. The mean gingival thickness in the connective tissue graft group exceeded that in the thin acellular dermal matrices group by 0.436 mm (95% confidence interval: 0.108 to 0.763; adjusted p = 0.036); the difference in the gingival thickness between the thick acellular dermal matrices and thin acellular dermal matrices groups was not statistically significant after adjustment (adjusted p = 0.073). Connective tissue graft and thick acellular dermal matrices groups had comparable observed means; however, the trial was not powered for equivalence. Postoperative visual analog scale scores were lower in both acellular dermal matrices groups than in the connective tissue graft group, and thin acellular dermal matrices group had a higher day-7 healing score than the thick acellular dermal matrices group.ConclusionsThe 18-month gingival thickness was greater in the connective tissue graft group than in the thin acellular dermal matrices group after multiplicity adjustment, whereas the mean values of the connective tissue graft and thick acellular dermal matrices groups were comparable. The study did not establish equivalence, and the root-coverage estimates were too imprecise to demonstrate comparability. Acellular dermal matrices avoided palatal donor-site harvesting and were associated with lower postoperative visual analog scale pain scores.Trial registrationChinese Clinical Trial Registry (WHO Primary Registry), ChiCTR2600124861.