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Abstract：
OBJECTIVE: This randomized clinical trial focused on patients with thin peri-implant soft-tissue height (STH) (≤ 2.5 mm) and investigated the impact of an allogenic collagen scaffold (aCS) on supracrestal tissue height and marginal bone loss (MBL).
METHODS: Forty patients received bone level implants and were randomly assigned to the test group with simultaneous tissue thickening with aCS or the control group. After three months, prosthetic restoration occurred. STH measurements were taken at baseline (T0) and reopening surgery (TR), with MBL assessed at 12 months (T1). Descriptive statistics were calculated for continuous variables, and counts for categorical variables (significance level, p = 0.05).
RESULTS: At T1, 37 patients were available. At T0, control and test groups had mean STH values of 2.3 ± 0.3 mm and 2.1 ± 0.4 mm. TR revealed mean STH values of 2.3 ± 0.2 mm (control) and 2.6 ± 0.7 mm (test), with a significant tissue thickening of 0.5 ± 0.6 mm in the test group (p < 0.03). At T1, control and test groups showed MBL mean values of 1.1 ± 0.8 mm and 1.0 ± 0.6 mm, with a moderate but significant correlation with STH thickening (-0.34), implant position (0.43), history of periodontitis (0.39), and smoking status (0.27).
CONCLUSIONS: The use of an aCS protocol resulted in soft tissue thickening but did not reach a threshold to reliably reduce MBL compared to the control group within the study\'s limitations.
CONCLUSIONS: Peri-implant STH is crucial for maintaining peri-implant marginal bone stability. Marginal bone stability represents a crucial factor in prevention of peri-implantitis development. German register of clinical trial registration number DRKS00033290.
METHODS: Forty patients received bone level implants and were randomly assigned to the test group with simultaneous tissue thickening with aCS or the control group. After three months, prosthetic restoration occurred. STH measurements were taken at baseline (T0) and reopening surgery (TR), with MBL assessed at 12 months (T1). Descriptive statistics were calculated for continuous variables, and counts for categorical variables (significance level, p = 0.05).
RESULTS: At T1, 37 patients were available. At T0, control and test groups had mean STH values of 2.3 ± 0.3 mm and 2.1 ± 0.4 mm. TR revealed mean STH values of 2.3 ± 0.2 mm (control) and 2.6 ± 0.7 mm (test), with a significant tissue thickening of 0.5 ± 0.6 mm in the test group (p < 0.03). At T1, control and test groups showed MBL mean values of 1.1 ± 0.8 mm and 1.0 ± 0.6 mm, with a moderate but significant correlation with STH thickening (-0.34), implant position (0.43), history of periodontitis (0.39), and smoking status (0.27).
CONCLUSIONS: The use of an aCS protocol resulted in soft tissue thickening but did not reach a threshold to reliably reduce MBL compared to the control group within the study\'s limitations.
CONCLUSIONS: Peri-implant STH is crucial for maintaining peri-implant marginal bone stability. Marginal bone stability represents a crucial factor in prevention of peri-implantitis development. German register of clinical trial registration number DRKS00033290.
摘要：
目的：这项随机临床试验的重点是薄的种植体周围软组织高度（STH）（≤2.5mm）的患者，并研究了同种异体胶原支架（aCS）对上组织高度和边缘骨丢失（MBL）的影响。
方法：40例患者接受了骨水平植入物，并随机分配到同时伴有aCS组织增厚的试验组或对照组。三个月后,修复发生。在基线（T0）和重新开放手术（TR）时进行STH测量，在12个月（T1）评估MBL。计算了连续变量的描述性统计量，和分类变量的计数(显著性水平，p=0.05)。
结果：T1时，有37例患者。在T0时,对照组和测试组具有2.3±0.3mm和2.1±0.4mm的平均STH值。TR显示平均STH值为2.3±0.2mm（对照）和2.6±0.7mm（测试），试验组组织明显增厚0.5±0.6mm(p<0.03)。在T1时，对照组和测试组显示MBL平均值为1.1±0.8mm和1.0±0.6mm，与STH增厚有中等但显着相关性（-0.34），植入物位置(0.43)，牙周炎病史（0.39），吸烟状况（0.27）。
结论：与对照组相比，使用aCS方案导致软组织增厚，但未达到可靠降低MBL的阈值。
结论：种植体周围的STH对于维持种植体周围边缘骨的稳定性至关重要。边缘骨稳定性是预防种植体周围炎发展的关键因素。德国临床试验注册登记号DRKS00033290。
方法：40例患者接受了骨水平植入物，并随机分配到同时伴有aCS组织增厚的试验组或对照组。三个月后,修复发生。在基线（T0）和重新开放手术（TR）时进行STH测量，在12个月（T1）评估MBL。计算了连续变量的描述性统计量，和分类变量的计数(显著性水平，p=0.05)。
结果：T1时，有37例患者。在T0时,对照组和测试组具有2.3±0.3mm和2.1±0.4mm的平均STH值。TR显示平均STH值为2.3±0.2mm（对照）和2.6±0.7mm（测试），试验组组织明显增厚0.5±0.6mm(p<0.03)。在T1时，对照组和测试组显示MBL平均值为1.1±0.8mm和1.0±0.6mm，与STH增厚有中等但显着相关性（-0.34），植入物位置(0.43)，牙周炎病史（0.39），吸烟状况（0.27）。
结论：与对照组相比，使用aCS方案导致软组织增厚，但未达到可靠降低MBL的阈值。
结论：种植体周围的STH对于维持种植体周围边缘骨的稳定性至关重要。边缘骨稳定性是预防种植体周围炎发展的关键因素。德国临床试验注册登记号DRKS00033290。
