Efficacy of keratinized mucosal augmentation with a collagen matrix concomitant to the surgical treatment of peri-implantitis: A dual-center randomized clinical trial.

AIM: The aim of this study was to evaluate the efficacy of a xenogeneic collagen matrix to augment the width of keratinized mucosa (KM), concomitantly to the surgical treatment of peri-implantitis, when compared to the use of an autologous soft tissue graft. MATERIAL AND METHODS: In this 12-month parallel-arm randomized controlled clinical trial, patients with peri-implantitis were randomly assigned, one month after non-surgical therapy, to surgical resective treatment of peri-implantitis consisting on an apically positioned flap (APF) in combination with a KM augmentation procedure, either with an autologous free gingival graft (FGG) or a collagen matrix (CM). Primary outcomes were the increase in the width of KM and probing pocket depth (PPD) reduction at 12 months. As secondary outcomes, peri-implant radiographic and patient-reported outcomes were assessed. RESULTS: The intention-to-treat population consisted of 49 subjects, assigned to either the APF + FGG (n = 23) or APF + CM (n = 26) group. PPDs were reduced by 1.6 mm (SD 1.0) and 1.7 mm (SD 1.2), respectively, being these differences non statistically significant (p = .782). However, the increase in KM was significantly higher in the APF + FGG compared with APF + CM (2.5 mm [SD 1.6] vs. 1.6 mm [SD 1.2], respectively (p = .033). CONCLUSION: The tested surgical modalities resulted in similar improvements of the clinical parameters. Both free gingival graft and collagen matrix significantly increased the peri-implant keratinized mucosa, but this KM gain was significantly higher with the free gingival graft. Use of CM, however, was better appreciated by the patients, in terms of pain perception and analgesic consumption, although the surgical time was similar.