Aim
To evaluate outcome measures in clinical studies on alveolar ridge augmentation (ARA) and map them to the Implant Dentistry Core Outcome Set and Measurement (ID-COSM) framework and the Food and Drug Administration (FDA) terminology.
Methods
A systematic search was carried out across four databases through June 2025. Randomised and non-randomised clinical trials, prospective clinical studies, cohort studies and pilot clinical studies evaluating ARA performed before or simultaneously with implant placement were included. Extracted outcomes were mapped to ID-COSM domains, subdomains and specific outcomes, and all were classified into FDA-style outcome types. Risk of bias (RoB) was assessed using Domain 4 of RoB 2.0/ROBINS-I, and associations between RoB and completeness of outcome reporting were analysed with Spearman's rank correlation and Kruskal–Wallis tests (a=0.05).
Results
Four hundred and twenty-nine studies were included, predominantly randomised controlled trials (56.4%). Less than half of the studies fulfilled the mandatory ID-COSM domains (47.6%), and none reported all nine subdomains. For mandatory outcomes, surgical complications (52.7%) and implant placement feasibility (48.3%) were more frequently reported than bone dimensional changes (33.8%), and peri-implant bone stability was reported in only 11.0% of studies. For FDA categorisation, clinician-reported outcomes (86.3%) and biomarkers (87.7%) predominated, while patient-reported outcomes were reported in 31.9% of studies. Observer-reported or performance outcomes were completely absent. Lower risk of bias was associated with more complete reporting of outcomes across domains, subdomains and specific outcomes (p=0.032, 0.017 and 0.009, respectively).
Conclusion
Outcome reporting for ARA trials is highly heterogeneous and poorly aligned with the standardised minimum outcomes recommended by ID-COSM and FDA categorisation.
Khushboo Kalani, Hamoun Sabri, Maaham Lodhi, Pranav Kataria, Shivam Patel, Lucrezia Parma-Benfenati, Muhammad H. A. Saleh
Disease Category: Dentistry & oral health
Disease Name: Dental implants
Age Range: 18 - 120
Sex: Either
Nature of Intervention: Surgery
- COS uptake study
- Systematic review