Background and Rationale:
Dental implant treatment success has traditionally been evaluated using clinical parameters such as implant survival, marginal bone loss, and tissue health from the clinician perspective. However, the shift toward value-based healthcare requires integration of patient-reported outcome measures (PROMs) to capture treatment value from the patient's perspective.
The recently published Implant Dentistry Core Outcome Set and Measurement (ID-COSM) international consensus established essential domains for implant research but lacks a validated, clinically feasible patient-reported outcome instrument. Existing dental PROMs like The Oral Health Impact Profile with 14 items are too general for implant-specific evaluation, while comprehensive tools like the ICHOM Adult Oral Health Standard Set are too lengthy for routine clinical use.
Study Design:
This prospective multicenter cohort study develops and validates the Dental Implant Set (DENS), a patient-reported outcome measure based on ID-COSM domains and items extracted from validated instruments (The Oral Health Impact Profile with 14 items, the Psychosocial Impact of Dental Aesthetics Questionnaire, the Patient Satisfaction Questionnaire with 18 items, the Dental Satisfaction Questionnaire, and the Quality of My Facial Questionnaire are used). The DENS captures four core domains: pathophysiology, implant/prosthesis lifespan, life impact, and functional outcomes.
Technical Implementation:
Data collection occurs through an integrated online platform using GemTracker and LimeSurvey. Participating clinics receive secure access credentials and standardized protocols. Patient questionnaires are distributed via secure links prior to appointments, with alternative in-clinic completion available. Clinical data entry occurs immediately post-appointment.
Validation Framework:
Psychometric evaluation includes internal consistency reliability (Cronbach's alpha), construct validity through confirmatory factor analysis, convergent validity via correlations with clinical parameters, and known-groups validity comparing patient subgroups. Test-retest reliability assessment occurs between stable timepoints.
Multicenter Design:
Approximately 30 dental implant clinics across Netherlands and Spain participate, each recruiting 50-60 patients. This design ensures diverse patient populations and practice settings while maintaining standardized data collection protocols through investigator calibration meetings.
Follow-up Schedule:
The study follows natural implant treatment phases with assessments at baseline (pre-implantation), 1-2 weeks post-implantation (surgical healing), 3 months post-implantation (tissue maturation), 3 months post-loading (initial functional adaptation), and 10 months post-loading (mature functional outcomes). This timeline aligns with standard implant care protocols.
Quality Assurance:
Standardization is maintained through investigator calibration, protocol training, and real-time data monitoring. Missing data patterns and completion rates are tracked to assess implementation feasibility. The pseudonymized data structure ensures patient privacy while enabling comprehensive analysis.
Expected Outcomes:
The validated DENS will provide a standardized, clinically feasible tool for routine implant outcome assessment, enabling benchmarking between practices, quality improvement initiatives, and value-based healthcare implementation in implant dentistry.
