Reconstructive surgical therapy of peri‐implantitis: A multicenter randomized controlled clinical trial

Abstract

Objective To evaluate the potential benefit of the use of a bone substitute material in the reconstructive surgical therapy of peri‐implantitis. Methods In this multicenter randomized clinical trial, 138 patients (147 implants) with peri‐implantitis were treated surgically, randomized by coin toss to either a control (access flap surgery) or a test group (reconstructive surgery using bone substitute material). Clinical assessments, including probing pocket depth (PPD), bleeding and suppuration on probing (BOP & SOP) as well as soft tissue recession (REC), were recorded at baseline, 6 and 12 months. Marginal bone levels (MBL), measured on intra‐oral radiographs, and patient‐reported outcomes (PROs) were recorded at baseline and 12 months. No blinding to group allocation was performed. The primary outcome at 12 months was a composite measure including (i) implant not lost, (ii) absence of BOP/SOP at all aspects, (iii) PPD ≤5 mm at all aspects and (iv) ≤1 mm recession of mucosal margin on the buccal aspect of the implant. Secondary outcomes included (i) changes of MBL, (ii) changes of PPD, BOP%, and buccal KM, (iii) buccal REC and (iv) patient‐reported outcomes. Results During follow‐up, four implants (one in the test group, three in the control group) in four patients were removed due to disease progression. At 12 months, a total of 69 implants in the test and 68 implants in the control group were examined. Thus, 16.4% and 13.5% of implants in the test and control group, respectively, met all predefined criteria of the composite outcome. PPD reduction and MBL gain were 3.7 mm and about 1.0 mm in both groups. Reduction in mean BOP% varied between 45% (test) and 50% (control), without significant differences between groups. Buccal REC was less pronounced in the test group (M = 0.7, SD = 0.9 mm) when compared to controls (M = 1.1, SD = 1.5 mm). PROs were favorable in both groups without significant differences. One case of allergic reaction to the antibiotic therapy was recorded. No other adverse events were noted. Conclusions Surgical therapy of peri‐implantitis effectively improved the clinical and radiographic status at 12 months. While the use of a bone substitute material did not improve reductions of PPD and BOP, buccal REC was less pronounced in the test group. Patient satisfaction was high in both groups.

Effect of sub‐marginal instrumentation before surgical treatment of peri‐implantitis: A multi‐centre randomized clinical trial

“…At the 12‐month examination, an overall 26.9% treatment success rate was found. This value is similar or even superior to other trials (Hallström et al, 2017 ; de Tapia et al, 2019 ; Polymeri et al, 2020 ; Renvert et al, 2021 ; Derks et al, 2022 ). However, using the same evaluation criteria, Carcuac et al ( 2016 ) reported a success rate of 45%.…”

“…At 6 and 12 months after surgery, an overall soft‐tissue recession of ≅2 mm has been observed, a value which is higher than in other randomized clinical trials (Renvert et al, 2021 ; Derks et al, 2022 ). Differences in the employed surgical approaches may possibly explain this discrepancy, because the present study also included resective surgeries.…”

“…At 6 and 12 months after surgery, a PPD reduction of ≅3 mm has been observed in both groups. This magnitude of reduction is consistent with most randomized clinical trials evaluating the efficacy of the surgical treatment of peri‐implantitis, irrespective of the implementation of sub‐marginal instrumentation before surgery or the use of different surgical approaches (Carcuac et al, 2016 ; Isehed et al, 2016 ; Jepsen et al, 2016 ; Hallström et al, 2017 ; Cha et al, 2019 ; de Tapia et al, 2019 ; Polymeri et al, 2020 ; Renvert et al, 2021 ; Derks et al, 2022 ).…”

Corrigendum

“…In Derks et al (2022), in Table 1, the column representing percentages in the Test Group has shifted in the version published online.…”

Hard and soft tissue regeneration of severe peri-implantitis defects with the laser-assisted peri-implant defect regeneration technique: 3-year results

“…In the test group, the peri-implant defects were grafted with a demineralized bovine bone mineral (DBBM) containing collagen (Bio-Oss Collagen®, Geistlich, Lucerne, Switzerland). With or without DBBM defect grafting the radiographic defect fill was 1.1 mm in sites with a marginal bone loss of 6.1 mm at baseline [ 4 ]. In another multi-center study with a similar set-up, DBBM (BioOss, Geistlich) covered by a collagen membrane (BioGide, Geistlich) was used in the test group [ 5 ].…”