Cross‐Linked Volume‐Stable Collagen Matrix Versus Connective Tissue Graft for Soft Tissue Augmentation at Implant Site. A Non‐Inferiority, Multicenter Randomized Clinical Trial
Abstract
ABSTRACT Aims To 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. Methods The 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). Results A 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). Conclusions Both techniques…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 98 participants or records.
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