1st Global Consensus for Clinical Guidelines: Identifying a Core Outcome Set for Implant Dentistry in Edentulous Maxilla Rehabilitation.

objectivesTo identify a core outcome set (COS) to standardize outcome measures for studies on the rehabilitation of the edentulous maxilla in implant dentistry. This work was conducted in preparation for the 1st Global Consensus for Clinical Guidelines (GCCG) for the Rehabilitation of the Edentulous Maxilla. MATERIALS AND

methodsThe COS was developed using a standardized and validated methodology, following the Core Outcome Measures in Effectiveness Trials (COMET) initiative. Outcomes were first identified through eight systematic reviews covering surgical and prosthetic aspects of edentulous maxilla rehabilitation. This preliminary list was expanded by input from clinical and cross-disciplinary experts as well as patient surveys to capture additional relevant outcomes that were not represented in the literature. A 3-round Delphi survey was conducted. The first round was conducted prior to the meeting and the second and third round took place during the in-person consensus meeting. In the first round, participants could propose new outcomes and rated each item using a 9-point Likert scale, from 1 (not important) to 9 (critical), with scores of 7-9 denoting critical importance, 4-6 importance, and 1-3 low importance for decision making. In the second round, participants re-scored a revised outcome list incorporating written suggestions and consolidated overlapping items from the first round. Outcomes rated 7-9 by at least 75% of participants in the second round constituted the final COS selection. In the third round, these selected outcomes were evaluated for their relevance across the different stages of the GCCG workflow: patient selection, diagnostic tools, treatment planning, treatment procedure, management of complications during the treatment procedure, maintenance, and management of complications during maintenance.

resultsOf the 105 experts invited, response rates for the three Delphi rounds were 87.6%, 95.2%, and 92.4%, respectively. An initial list of 119 outcomes was generated from systematic reviews and surveys and subsequently refined after the first round based on participant feedback. In the second round, 34 outcomes were rated as critical and included in the final COS. These comprised 10 patient-reported outcomes (PROs): aesthetic satisfaction; chewing function/comfort/discomfort; complications during treatment/maintenance; ease of cleaning/oral hygiene efficacy; pain; patient overall satisfaction with treatment; patient-reported complaints; prosthesis retention/stability; quality of life; speech/phonetics/pronunciation function, 22 objective clinician-reported outcomes (ClinROs): biological complications; history of patient compliance; implant failure; implant primary stability; implant success; implant survival; mechanical/technical complications; peri-implant health (implant level); peri-implant health (patient level); peri-implant mucositis; peri-implant suppuration; peri-implantitis; plaque index/oral hygiene; postoperative complications; presence of keratinized mucosa; prosthesis failure; prosthesis success; prosthetic complications; radiographic marginal bone level; radiographic marginal bone loss; surgical/intraoperative complications; width of keratinized mucosa and two subjective ClinROs (clinician's treatment success; prosthodontic maintenance events/complications). Additional outcomes proposed during the second round were excluded since they represented general comments, process indicators, or alternative wording of outcomes already considered. In the third round, 21 COS outcomes were deemed relevant to the maintenance and/or post-treatment complication management phases, 3 were deemed relevant before treatment, and another 3 were deemed relevant only during treatment.

conclusionThe proposed COS for studies on the rehabilitation of the edentulous maxilla in implant dentistry was developed using the COMET methodology. Although patients' perspectives were incorporated during the preliminary survey phase, they did not participate directly in the Delphi, highlighting an opportunity for future research to further enhance patient involvement in COS development. The widespread implementation of this COS is expected to improve the consistency of outcome reporting and facilitate comparisons of the effectiveness of current and emerging interventions.