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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. [ABSTRACT FROM AUTHOR]

ABSTRACT Objective Methods Results Conclusion Trial Registration To evaluate the potential mid‐term benefit of the use of a bone substitute material in the reconstructive surgical treatment of peri‐implantitis.A total of 120 subjects (127 implants) affected by peri‐implantitis were followed over 3 years in a multicenter randomized clinical trial. Participants had been randomized to either control (access flap surgery) or test group (access flap surgery and bone substitute material). Clinical, radiographic, and patient‐reported outcomes were assessed. The primary outcome was a composite measure including probing pocket depth ≤ 5 mm, absence of bleeding and suppuration on probing, soft tissue recession ≤ 1 mm, and implant neither reoperated nor lost. In an additional outcome (disease resolution), we allowed for one bleeding site and did not consider recession.While 14 implants (11%) were lost and a second surgical intervention had been performed at 3 implants (2.4%), pronounced improvements of clinical parameters were noted at remaining implants in both treatment groups at the 3‐year follow‐up. This was illustrated by a 3.2–3.5 mm reduction in probing pocket depth and a marginal bone level gain of 1.1–1.3 mm. The primary composite outcome, however, was only achieved at 14% of implants. The second composite outcome defining disease resolution was accomplished at 39% of implants. Patient‐reported outcomes were generally favorable.At 3 years, the use of a bone substitute material in the surgical therapy of peri‐implantitis did not result in a clear benefit over access flap surgery alone.ClinicalTrials.gov identifier: NCT0307706 [ABSTRACT FROM AUTHOR]