This manuscript presents the first globally agreed-upon Core Outcome Set (COS) for studies on implant-supported rehabilitation of the edentulous maxilla, developed through a structured Delphi process with participation from 108 international experts. While previous initiatives such as the ID-COSM project (https://www.comet-initiative.org/Studies/Details/1765) laid important groundwork for standardizing outcome reporting in implant dentistry, the field remains complex and highly multidisciplinary, involving various specialists and a broad range of clinical scenarios (e.g., rehabilitation of partially or fully edentulous arches in the maxilla, mandible, or both). As such, earlier COS efforts, though essential, require further refinement to address this diversity in practice and perspective.
Following the COMET methodology and drawing on eight systematic reviews and stakeholder surveys, this study identified 34 key outcomes, 10 patient-reported outcomes (PROs), 22 objective clinician-reported outcomes (ClinROMs), and 2 subjective ClinROMs, to enhance consistency and comparability in clinical research. These include crucial endpoints such as patient satisfaction, chewing function, implant and prosthesis success, and peri-implant health. Outcomes were also mapped to specific phases of care, highlighting the need for standardized timing in data collection. Broad implementation of this COS is expected to strengthen research quality, support meaningful meta-analyses, and guide the development of evidence-based clinical guidelines worldwide.
Franz J. Strauss (PI)
Clinic of Reconstructive Dentistry, Center of Dental Medicine, University of Zurich, Zurich, Switzerland
Giulia Brunello (PI)
Department of Oral Surgery, University Hospital of Düsseldorf, Düsseldorf, Germany
Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Department of Orthodontics and Dentofacial Orthopaedics, Berlin, Germany
Ina Kopp (Co-investigator)
AWMF-Institut für Medizinisches Wissensmanagement, Philipps-Universität Marburg, Marburg, Germany
Ronald E. Jung (Co-investigator)
Clinic of Reconstructive Dentistry, Center of Dental Medicine, University of Zurich, Zurich, Switzerland
Hom-Lay Wang (Co-PI)
Department of Periodontics & Oral Medicine, University of Michigan School of Dentistry, Ann Arbor, MI, USA
Frank Schwarz (Co-PI)
Department of Oral Surgery and Implantology, Goethe University, Frankfurt am Main, Germany
Disease Category: Dentistry & oral health
Disease Name: Maxillary Edentulism
Age Range: 19 - 100
Sex: Either
Nature of Intervention: Dental implant, Surgery
- Clinical experts
- Conference participants
- Consumers (patients)
- Device manufacturers
- Journal editors
- Methodologists
- Researchers
- Statisticians
- COS for clinical trials or clinical research
- COS for practice
- Consensus conference
- Consensus meeting
- Delphi process
- Literature review
- Nominal group technique (NGT)
- Semi structured discussion
- Survey
- Systematic review
The COS was identified using a standardized and validated methodology, following the Core Outcome Measures in Effectiveness Trials (COMET) initiative. Outcomes were identified from eight systematic reviews covering surgical and prosthetic aspects of edentulous maxilla rehabilitation. This generated list was then expanded to include outcomes that were present in expert, as well as cross-disciplinary expert/patient surveys conducted in preparation to the GCCG. Outcomes were rated 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. The list was refined and additional outcomes from first round were incorporated. Outcomes rated 7–9 by at least 75% of participants in the second round constituted the final COS selection. These were then evaluated in a third round to determine their relevance at different stages of the GCCG workflow (i.e., patient selection; diagnostic tools; treatment planning; treatment procedure; management of complications during treatment procedure; maintenance; management of complications during maintenance).