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Consensus on a valid and comprehensive set of outcomes to capture the full benefits and harms of implant dentistry interventions is key for progressing toward better clinical guidelines and policy. In this field, research remains fragmented and uses too many different outcomes. Studies are unable to cover the full breadth necessary to properly evaluate benefits, harms, and costs. Best-practice examples inspired the Implant Dentistry Core Outcome Set and Measurements (ID-COSM) initiative that identified four core outcome domain areas (pathophysiology, implant/prosthesis lifespan, life impact, and access to care), five essential outcomes mandatory for all trials, and six outcomes mandatory in specific circumstances. This innovative multistep approach combined input from scientific evidence, patients from multiple countries, methodologists, and industry representatives. The ID-COSM consensus aspires to contribute to better adoption of relevant and valid outcomes in trials and enable their results to be combined in high-quality meta-analyses to support better-informed care and policy. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the efficacy of reconstructive peri‐implantitis treatment. Materials and Methods: Forty participants, with peri‐implantitis and a contained intraosseous defect, were randomized to access flap (control) or access flap with xenograft and collagen membrane (test). All received systemic antimicrobials. Blinded examiners recorded probing depths (PD), bleeding and suppuration on probing (BOP & SOP), soft tissue levels, and marginal bone levels (MBL) at baseline and 12 months. Patient reported outcomes were recorded. The primary outcome was PD change. Results: All 40 participants (40 implants) completed the 12‐month study. The mean (standard deviation) PD reduction (deepest site) was 4.2 (1.8) mm in the control and 3.7 (1.9) mm in the test group. MBL gain (deepest site) was 1.7 (1.6) mm in the control and 2.4 (1.4) mm in the test group. Absence of BOP & SOP was observed at 60% of both control and test implants. Buccal recession was 0.9 (1.6) mm in the control and 0.4 (1.1) mm in the test group. A successful outcome (absence of PD ≥ 5 mm with BOP, absence of SOP and absence of progressive bone loss) was achieved for 90% of the control and 85% of test group implants. No statistically significant differences in clinical or radiographic parameters were found between treatment groups. 30% of participants experienced mild gastro‐intestinal disturbances. Reporting followed CONSORT guidelines. Conclusion: Similar clinical and radiographic improvements at 12 months were observed with high levels of patient satisfaction for both the access flap and xenograft covered by collagen membrane groups. Registered clinical trials.gov. ID:NCT03163602 (23/05/2017). [ABSTRACT FROM AUTHOR]

Aim: Lack of consistently reported outcomes limits progress in evidence‐based implant dentistry and quality of care. The objective of this initiative was to develop a core outcome set (COS) and measurements for implant dentistry clinical trials (ID‐COSM). Materials and Methods: This Core Outcome Measures in Effectiveness Trials (COMET)‐registered international initiative comprised six steps over 24 months: (i) systematic reviews of outcomes reported in the last 10 years; (ii) international patient focus groups; (iii) a Delphi project with a broad range of stakeholders (care providers, clinical researchers, methodologists, patients and industry representatives); (iv) expert group discussions organizing the outcomes in domains using a theoretical framework and identifying the COSs; (v) identification of valid measurement systems to capture the different domains and (vi) final consensus and formal approval involving experts and patients. The methods were modified from the best practice approach following the Outcome Measures in Rheumatoid Arthritis Clinical Trial and COMET manuals. Results: The systematic reviews and patient focus groups identified 754 (665 + 89, respectively) relevant outcome measures. After elimination of redundancies and duplicates, 111 were formally assessed in the Delphi project. By applying pre‐specified filters, the Delphi process identified 22 essential outcomes. These were reduced to 13 after aggregating alternative assessments of the same features. The expert committee organized them into four core outcome areas: (i) pathophysiology, (ii) implant/prosthesis lifespan, (iii) life impact and (iv) access to care. In each area, core outcomes were identified to capture both the benefits and harms of therapy. Mandatory outcome domains included assessment of surgical morbidity and complications, peri‐implant tissue health status, intervention‐related adverse events, complication‐free survival and overall patient satisfaction and comfort. Outcomes deemed mandatory in specific circumstances comprised function (mastication, speech, aesthetics and denture retention), quality of life, effort for treatment and maintenance and cost effectiveness. Specialized COSs were identified for bone and soft‐tissue augmentation procedures. The validity of measurement instruments ranged from international consensus (peri‐implant tissue health status) to early identification of important outcomes (patient‐reported outcomes identified by the focus groups). Conclusions: The ID‐COSM initiative reached a consensus on a core set of mandatory outcomes for clinical trials in implant dentistry and/or soft tissue/bone augmentation. Adoption in future protocols and reporting on the respective domain areas by currently ongoing trials will contribute to improving evidence‐informed implant dentistry and quality of care. [ABSTRACT FROM AUTHOR]

Objectives: To assess the literature on (i) the relevance of the presence of a minimum dimension of keratinized peri‐implant mucosa (KPIM) to maintain the health and stability of peri‐implant tissues, and; (ii) the surgical interventions and grafting materials used for augmenting the dimensions of the KPIM when there is a minimal amount or absence of it. Material & Methods: Two systematic reviews complemented by expert opinion from workshop group participants served as the basis of the consensus statements, implications for clinical practice and future research, and were approved in plenary session by all workshop participants. Results: Thirty‐four consensus statements, eight implications for clinical practice, and 13 implications for future research were discussed and agreed upon. There is no consistent data on the incidence of peri‐implant mucositis relative to the presence or absence of KPIM. However, reduced KPIM width is associated with increased biofilm accumulation, soft‐tissue inflammation, greater patient discomfort, mucosal recession, marginal bone loss and an increased prevalence of peri‐implantitis. Free gingival autogenous grafts were considered the standard of care surgical intervention to effectively increase the width of KPIM. However, substitutes of xenogeneic origin may be an alternative to autogenous tissues, since similar results when compared to connective tissue grafts were reported. Conclusion: Presence of a minimum width of KPIM should be assessed routinely in patients with implant supported restorations, and when associated with pathological changes in the peri‐implant mucosa, its dimensions may be surgically increased using autogenous grafts or soft‐tissue substitutes with evidence of proven efficacy. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate the success of treatments aimed at the resolution of peri-implantitis in patients with osseointegrated implants. Materials and Methods: The potentially relevant literature was assessed independently by two reviewers to identify case series and comparative studies describing the treatment of peri-implantitis with a follow-up of at least 3 months. Medline, Embase, and The Cochrane Library were searched. For the purposes of this review, a composite criterion for successful treatment outcome was used which comprised implant survival with mean probing depth < 5 mm and no further bone loss. Results: A total of 43 publications were included: 4 papers describing 3 nonsurgical case series, 13 papers describing 10 comparative studies of nonsurgical interventions, 15 papers describing 14 surgical case series, and 11 papers describing 6 comparative studies of surgical interventions. No trials comparing nonsurgical with surgical interventions were found. The length of follow-up varied from 3 months to 7.5 years. Due to the heterogeneity of study designs, peri-implantitis case definitions, outcome variables, and reporting, no meta-analysis was performed. Eleven studies could be evaluated according to a composite success criterion. Successful treatment outcomes at 12 months were reported in 0% to 100% of patients treated in 9 studies and in 75% to 93% of implants treated in 2 studies. Commonalities in treatment approaches between studies included (1) a pretreatment phase, (2) cause-related therapy, and (3) a maintenance care phase. Conclusions: While the available evidence does not allow any specific recommendations for the therapy of peri-implantitis, successful treatment outcomes at 12 months were reported in a majority of patients in 7 studies. Although favorable short-term outcomes were reported in many studies, lack of disease resolution as well as progression or recurrence of disease and implant loss despite treatment were also reported. The reported outcomes must be viewed in the context of the varied peri-implantitis case definitions and severity of disease included as well as the heterogeneity in study design, length of follow-up, and exclusion/inclusion criteria. [ABSTRACT FROM AUTHOR]

The article evaluates three systematic reviews published in the issue, including reviews of the articles "Effects of Anti-Infective Preventive Measures of Biologic Implant Complications and Implant Loss: A Systematic Review" by Giovanni Salvi and Nicola U. Zitzmann, "Therapy of Peri-Implantitis: A Systematic Review" by Lisa J. Hetz-Mayfield and Andrea Mombelli and "Survival Rates of Implant-Supported Fixed Prostheses over the Last Decade: Comparison of Survival and Complication Rates in Older and Newer Publications" by Bijami E. Pjetursson, Asgeir G. Asgeirsson, Marcel Zwahlen et al., with statements and recommendations on the management of implant complications