Outcome Measures and ID-COSM Reporting Standards in Alveolar Ridge Augmentation: A Systematic Review of Clinical...

Area of Science:

• Dental Implantology
• Regenerative Medicine
• Clinical Trial Methodology

Background:

• Alveolar ridge augmentation (ARA) is crucial for dental implant success.
• Standardized outcome measures are essential for evaluating ARA efficacy.
• Existing outcome reporting in ARA studies lacks consistency.

Purpose of the Study:

• To systematically evaluate outcome measures used in clinical studies on alveolar ridge augmentation (ARA).
• To map reported outcomes to the Implant Dentistry Core Outcome Set and Measurement (ID-COSM) framework.
• To classify outcomes using Food and Drug Administration (FDA) terminology.

Main Methods:

• Systematic literature search across four databases up to June 2025.
• Inclusion of randomized and non-randomized clinical trials, prospective studies, and cohort studies on ARA.
• Extraction and mapping of outcomes to ID-COSM domains/subdomains and classification into FDA outcome types.
• Risk of bias assessment and analysis of its association with outcome reporting completeness.

Main Results:

• 429 studies were included; less than half met mandatory ID-COSM domains, and none reported all subdomains.
• Surgical complications and implant feasibility were more reported than bone dimensional changes or peri-implant bone stability.
• Clinician-reported outcomes and biomarkers predominated in FDA categorization; patient-reported outcomes were infrequent.
• Lower risk of bias correlated with more complete outcome reporting across all levels.

Conclusions:

• Outcome reporting in alveolar ridge augmentation trials is highly heterogeneous.
• Current reporting practices poorly align with standardized minimum outcomes recommended by ID-COSM.
• There is a significant gap in aligning ARA study outcomes with FDA categorization and ID-COSM standards.