Cross‐Linked Volume‐Stable Collagen Matrix Versus Connective Tissue Graft for Soft Tissue Augmentation at Implant Site. A Non‐Inferiority, Multicenter Randomized Clinical Trial

IF 5.3 1区医学 Q1 DENTISTRY, ORAL SURGERY & MEDICINE

Clinical Oral Implants Research Pub Date : 2025-09-23 DOI:10.1111/clr.70050

Francesco Cairo, Cosimo Rupe, Raffaele Cavalcanti, Luca Landi, Antonio Rupe, Nicola Marco Sforza, Walter Castelluzzo, Maria Di Martino, Luigi Barbato

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引用次数: 0

Abstract

AimsTo compare the efficacy of cross‐linked volume‐stable collagen matrix (VCMX) versus connective tissue graft (CTG) to increase buccal peri‐implant mucosal thickness (MT) around dental implants.MethodsThe present is a parallel, randomized multi‐center clinical trial, according to the CONSORT statement. Clinical centers were four Italian periodontal settings. All patients received a soft tissue augmentation procedure, by means of CTG or VCMX. The primary outcome variable was peri‐implant mucosal thickness (MT) difference at 12 months follow‐up. The statistical unit was the patient. An analysis of covariance was performed for this outcome variable. Secondary outcomes were patient‐reported outcome measures (PROMs), complications, variability among operators, and changes in keratinized mucosa width (KMW).ResultsA total of 98 patients completed the study, 49 in each group. MT increase was 1.0 ± 0.75 in the CTG group and 0.66 ± 0.58 mm in the VCMX group. CTG showed superior results to VCMX for MT gain (0.37 mm, 95% CI: 0.13–0.61, p = 0.002). In cases of Baseline MT ≥ 2 mm, CTG and VCMX yielded comparable results. VCMX was associated with shorter chair time (diff: 10.0 min; 95% CI: 5.02 to 14.98; p < 0.0001). Patients in the VCMX group experienced fewer days of discomfort (0.46 days, 95% CI: 0.06–0.99, p = 0.05), while no differences were found for final aesthetic and general satisfaction (CTG: 99.28 ± 2.28, VCMX: 98.48 ± 3.92, p = 0.22).ConclusionsBoth techniques improved MT, and CTG yielded better outcomes. VCMX was associated with shorter chair time and less postoperative discomfort, but both procedures achieved excellent final patient satisfaction.

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交联体积稳定的胶原基质与结缔组织移植物在种植体部位的软组织增强。一项非劣效性、多中心随机临床试验

目的比较交联体积稳定型胶原基质（VCMX）与结缔组织移植物（CTG）在增加种植体周围口腔黏膜厚度（MT）方面的效果。方法：根据CONSORT声明，本研究是一项平行、随机的多中心临床试验。临床中心是四个意大利牙周设置。所有患者均通过CTG或VCMX接受软组织增强手术。主要结局变量为12个月随访时种植体周围粘膜厚度（MT）差异。统计单位是病人。对该结果变量进行协方差分析。次要结果是患者报告的结果测量值（PROMs）、并发症、操作人员之间的差异和角化粘膜宽度（KMW）的变化。结果共98例患者完成研究，每组49例。CTG组MT增加1.0±0.75 mm， VCMX组MT增加0.66±0.58 mm。CTG在MT增益方面优于VCMX （0.37 mm, 95% CI: 0.13-0.61, p = 0.002）。在基线MT≥2mm的情况下，CTG和VCMX的结果相当。VCMX与较短的坐椅时间相关（差异：10.0 min; 95% CI: 5.02至14.98;p < 0.0001）。VCMX组患者的不适天数较少（0.46天，95% CI: 0.06-0.99, p = 0.05），而最终美学和总体满意度无差异（CTG: 99.28±2.28,VCMX: 98.48±3.92,p = 0.22）。结论两种技术均能改善MT， CTG治疗效果更好。VCMX与更短的坐椅时间和更少的术后不适相关，但两种手术都获得了极好的最终患者满意度。

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来源期刊

Clinical Oral Implants Research 医学-工程：生物医学

CiteScore

7.70

自引率

11.60%

发文量

149

审稿时长

3 months

期刊介绍： Clinical Oral Implants Research conveys scientific progress in the field of implant dentistry and its related areas to clinicians, teachers and researchers concerned with the application of this information for the benefit of patients in need of oral implants. The journal addresses itself to clinicians, general practitioners, periodontists, oral and maxillofacial surgeons and prosthodontists, as well as to teachers, academicians and scholars involved in the education of professionals and in the scientific promotion of the field of implant dentistry.