International collaboration to develop a dental implant standard set: study protocol for a multicentre prospective cohort study for the validation of a core outcome set.

INTRODUCTION

Dental implants are a widely accepted solution for tooth replacement, but standardised outcome assessment, particularly patient-reported outcomes, remains limited. Moreover, international variability in implantology practices underscores the need for consistent and comprehensive evaluation tools. This study aims to develop and validate the DEntal implaNt Set (DENS), a standardised tool to capture clinician and patient perspectives on peri-implant health and restorative treatment outcomes.

METHODS AND ANALYSIS: This prospective multicentre cohort study aims to include 1000 patients aged 18-75 years from 30 dental practices in the Netherlands and Spain. The DENS was developed by an international multidisciplinary team through structured iterative working sessions, grounded in the mandatory outcome domains of the Implant Dentistry Core Outcome Set and Measurement (ID-COSM) framework and informed by expert consultation with the ID-COSM authors. Patient-reported outcome measure (PROM) items were adapted from validated instruments and subjected to forward-backward translation into Dutch, English and Spanish. Data are collected at six time points from pre-implant placement to 12-month follow-up. Clinical outcomes and PROMs are assessed via the digital. Descriptive analyses and psychometric testing of the DENS instrument are planned at the end of the data collection phase.

ETHICS AND DISSEMINATION: Ethical approval was granted by committees in the Netherlands (Erasmus University Medical Center: MEC-2023-0688; Anna Hospital Eindhoven: 2024.076; Anna Hospital Geldrop: MEC-24.008; St. Antonius Hospital: R&D/Z24.070/DENS; University Medical Center Groningen: METc 2024/389) and Spain (CEI-SL 2024/122). Participants provide informed consent, and no procedures exceed standard clinical care. All data are pseudo-anonymised. Findings will be shared through publications, conferences and professional networks. The DENS tool will be made available for clinical practice and research purposes to promote standardised, evidence-based practice in implant dentistry.

TRIAL REGISTRATION NUMBER: NCT07337057.