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Surgical treatment of peri-implantitis defects with two different xenograft granules: A randomized clinical pilot study.

ABSTRACT: Objectives: To investigate whether xenograft EB (EndoBon) is non-inferior to xenograft BO (Bio-Oss) when used in reconstructive surgery of peri-implant osseous defects.

Materials and methods: Dental patients with one implant each demonstrating peri-implantitis were randomized to receive surgical debridement and defect fill with either BO or EB. Changes in bone level (BL) and intrabony defect depth (IDD) evaluated radiographically were the primary outcomes. The secondary outcomes included changes in probing pocket depth (PPD), bleeding on probing (BoP), and suppuration on probing (SoP). All outcomes were recorded before treatment and at 6 and 12 months post-treatment.

Results: Twenty-four patients (n = 11 BO, n = 13 EB) completed the study. Both groups demonstrated significant within-group improvements in all clinical and radiographic parameters at 6 and 12 months (p ? .001). At 12 months, both groups presented with IDD reductions of 2.5-3.0 mm on average. The inter-group differences were not statistically significant at all time points and for all the examined parameters (p > .05). While the radiographic defect fill in both groups exceeded > 1 mm and can be considered treatment success, successful treatment outcomes as defined by Consensus Reporting (no further bone loss, PPD ? 5 mm, no BOP, and no SoP) were identified in 2/11 (18%) BO and 0/13 (0%) EB individuals (Fisher's exact test, p = .199).

Conclusions: Within the limitations of this pilot study, the application of xenograft EB showed to be non-inferior to xenograft BO when used in reconstructive surgery of peri-implant osseous defects.

SUBMITTER: Polymeri A

PROVIDER: S-EPMC7693249 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature

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Surgical treatment of peri-implantitis defects with two different xenograft granules: A randomized clinical pilot study.

Polymeri Angeliki A Anssari-Moin David D van der Horst Joyce J Wismeijer Daniel D Laine Marja L ML Loos Bruno G BG

Clinical oral implants research 20200909 11

<h4>Objectives</h4>To investigate whether xenograft EB (EndoBon) is non-inferior to xenograft BO (Bio-Oss) when used in reconstructive surgery of peri-implant osseous defects.<h4>Materials and methods</h4>Dental patients with one implant each demonstrating peri-implantitis were randomized to receive surgical debridement and defect fill with either BO or EB. Changes in bone level (BL) and intrabony defect depth (IDD) evaluated radiographically were the primary outcomes. The secondary outcomes inc ...[more]

PMID: 32803798

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Project description:ObjectiveTo evaluate the potential benefit of the use of a bone substitute material in the reconstructive surgical therapy of peri-implantitis.MethodsIn 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.ResultsDuring 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.ConclusionsSurgical 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.

Project description:AimThe present multi-centre randomized clinical trial with 12 months of follow-up aimed at studying the added effect of sub-marginal instrumentation before surgical treatment of peri-implantitis.Materials and methodsForty-two patients diagnosed with peri-implantitis were recruited. After a behavioural intervention phase including oral hygiene instructions, patients were randomized to either receiving supra- and sub-marginal instrumentation on their affected implants (control group: 21 patients and 29 implants) or only supra-marginal instrumentation (test group: 21 patients and 24 implants), before undergoing surgery. Changes in the deepest probing pocket depth (PPD) with respect to baseline and a composite outcome of treatment success (no implant loss, no bone loss > 0.5 mm, no bleeding or suppuration on probing [BoP/SoP], and PPD ≤ 5 mm) at the 12-month examination were regarded as the primary outcomes of the trial.ResultsAt the 12-month examination, changes in the deepest PPD with respect to baseline amounted to -2.96 mm in the control group and to -3.11 mm in the test one (MD = -0.16; SE = 0.56; p = .769), while 21.4% of the implants in the control group and 33.3% in the test group presented treatment success (OR = 1.83; SE = 1.15; p = .338). With the exception of a longer non-surgical treatment duration in the control group (differences in = -14.29 min; SE = 2.91; p < .001), no other secondary (e.g., soft-tissue recession, keratinized mucosa height, and bone level changes, as well as BoP, SoP, profuse bleeding and implant loss rates) or exploratory (i.e., early wound healing, aesthetics, surgical and total treatment duration, surgery difficulty, intra-operative bleeding, and adverse events) outcome demonstrated statistically significant differences between groups.ConclusionsThe present multi-centre randomized clinical trial did not demonstrate an added effect of performing sub-marginal instrumentation 6 weeks before the surgical treatment of peri-implantitis. Larger clinical trials are however needed to confirm the present findings (Clinicaltrials.gov: NCT03620331).

Project description:BackgroundA variety of interventions have been explored in the non-surgical management of peri-implantitis. In spite of extensive testing of various study protocols, effective treatments largely remain unavailable. The objective of the present 12-month single-centre, examiner-masked, randomized controlled clinical trial was to explore whether a low-abrasive erythritol air-polishing system produces added clinical benefit when used adjunctive to conventional non-surgical management of peri-implantitis and to record any associated patient-centered outcomes.MethodsForty-three patients with mild to severe peri-implantitis including at least one implant either received ultrasonic/curette subgingival instrumentation and erythritol air-polishing (test) or ultrasonic/curette instrumentation only (control) at baseline and at 3, 6, 9, and 12 months. Probing depth (PD), bleeding on probing (BoP), dental plaque, suppuration (SUP), crestal bone level (CBL), and peri-implant crevicular fluid (PCF) were recorded at baseline, 6 and 12 months. Visual Analogue Scale (VAS) scores were collected immediately following subgingival interventions at all time-points.ResultsA reduction in PD was observed from baseline to 6 months for the test (p = 0.006) and control (p < 0.001) and from baseline to 12 months for the control (p < 0.001). No intergroup differences were observed for primary outcome variables PD or CBL over time (p > 0.05). At 6 months, a intergroup difference in PCF was observed in favor of the test (p = 0.042). Moreover, a reduction in SUP from baseline to 6 and 12 months was observed in the test (p = 0.019). Overall, patients in the control group experienced less pain/discomfort compared with the test (p < 0.05), females reporting more pain/discomfort than males (p = 0.005).ConclusionsThis study confirms that conventional non-surgical management of peri-implantitis produces limited clinical improvement. It is shown that an erythritol air-polishing system may not produce added clinical benefits when used adjunctive to conventional non-surgical management. In other words, neither approach effectively resolved peri-implantitis. Moreover, the erythritol air-polishing system produced added pain/discomfort particularly in female patients.Trial registrationThe clinical trial was prospectively registered in ClinicalTrials.gov with registration NCT04152668 (05/11/2019).

Dataset Information

Surgical treatment of peri-implantitis defects with two different xenograft granules: A randomized clinical pilot study.

Publications

Surgical treatment of peri-implantitis defects with two different xenograft granules: A randomized clinical pilot study.

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