An observational study in Tooth Loss / Rehabilitation, sponsored by Erasmus Medical Center. Recruiting at 1 site in Netherlands. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-01-13.
Sponsored by Erasmus Medical Center · Observational
Rationale Over the past decades, the placement of dental implants and prosthetic rehabilitation has revolutionised dentistry overwhelmingly. It is generally regarded as a safe and reliable method due to the high predictability and survival rates. Survival of suprastructure and implant, health status of the peri-implant tissues and radiographic peri-implant marginal bone loss are commonly used criteria to assess the implant treatment outcome. Although this way of treatment evaluation is important to develop and deliver safe dental implants, it does not provide sufficient information for the development of value-based healthcare.
With this new approach of health outcome measurement, in which patient reported outcomes and clinical outcomes are combined, new definitions of success are created that transform dental implant health care by informed decision making, quality improvement and reducing costs. If dentists and oral surgeons make treatment decisions based on this comprehensive health outcome, patients are more likely to receive high quality care and payers only pay for services that achieve results. Therefore, the development of an implant dentistry specific question set, a Dental Implant Standard Set, capturing both the clinicians' and patients' perspective of implant-related health outcomes is of utmost clinical relevance.
Objective(s) A combination of patient-reported outcomes and clinical health outcomes in a Dental Implant Standard Set enables clinicians to evaluate care delivery and to compare performance in a comprehensive and meaningful way. Therefore, the main aim for this project is to implement a workable Dental Implant Standard Set for the dental implant professional to monitor and improve clinicians and patients' perception of peri-implant health following dental implant treatment, and to monitor and improve the performance of dental implant practice as a whole.
Study type This is a prospectively designed multicenter cohort study including 30 dental practices in the Netherlands and Spain
Study population A total of 1000 consecutive patients will be included by the participating dental practices within 12 months.
Questionnaires regarding the clinical outcomes are administered to the dentists providing the dental implant care. PROMs are administered to the participating patients.
Generally, patients aged 18-70 years that have an indication for implant supported fixed single or multiple tooth replacement or implant-supported removable prosthesis are eligible to participate.
Methods the questionnaires are administered to the participating dentist (for clinical outcomes) and patients (Patient Reported Outcome Measures (PROMs) in combination with the collection of clinical and case mix variables at 6 time points: before and at implant placement, at prosthesis placement and 10-12 months after implant placement. The PROMs is administered via a Questionnaire Manager (QM), that is developed by an external company. Within the QM also case mix and clinical data are registered
Burden and risks No risks are involved throughout the study The concise questionnaires to the patients and participating dentist will be a limited burden to the standard dental implant care.
Recruitment and consent Treating clinicians will recruit participants for this project. Clinicians will provide the patient with a brief overview of the study. Participants will receive a digital questionnaire via a link with an informed consent form and contact details (of the principal investigator) for remaining questions.
Data is not open accessible and patient specific data will be anonymously stored.
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.
165 studies on the registry are indexed under Tooth Loss; 44 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 80 across 40 observational studies indexed under Tooth Loss.
Browse Tooth Loss studies →Erasmus Medical Center is the lead sponsor of 478 studies on the registry; 183 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All patients aged 18-70 years that have an indication for implant supported fixed single or multiple tooth replacement or implant-supported removable prosthesis are eligible to participate in this study. This study will also include patients with immediate implant placement and implant placement after implant failure.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients (18 years and older) that require implants for tooth rehabilitation after loss of tooth/teeth..
Device: Implantology
Implantology is a branch of dentistry focused on the placement and maintenance of dental implants, which are artificial tooth roots made typically from titanium. These implants are surgically inserted into the jawbone to support crowns, bridges, or dentures, providing a stable and long-lasting solution for missing teeth. Implantology involves careful planning, surgical procedures, and prosthetic restoration, often requiring collaboration between dental specialists. It aims to restore function, aesthetics, and patient quality of life.
Patient-reported outcomes measures
1\. Feasibility of DENS Implementation Measure: Completion rate percentage across all timepoints Time Frame: Baseline, 1-2 weeks post-implantation, 3 months post-implantation, 3 months post-loading, 10 months post-loading Description: Percentage of enrolled patients completing DENS questionnaire at each timepoint. Target ≥80% completion rate for clinical implementability.
Time frame: Follow up from 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
Internal Consistency Reliability
Measure: Cronbach's alpha coefficient for DENS domains Time Frame: At study completion (10 months post-loading) Description: Internal consistency reliability based on ID-COSM domains. Target α ≥0.7 for acceptable reliability.
Time frame: Follow up from 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
Secondary outcome measures
DENS Questionnaire Validation: Test-Retest Reliability Measure: Intraclass correlation coefficient (ICC) Time Frame: Between baseline and 1-2 weeks post-implantation (clinically stable period) Description: Temporal stability of DENS scores in patients without complications. Target ICC ≥0.7.
Time frame: Follow up from 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
Responsiveness to Treatment Phases Measure: Effect sizes (Cohen's d) for DENS domain changes
Responsiveness to Treatment Phases Measure: Effect sizes (Cohen's d) for DENS domain changes Time Frame: Between treatment phases (implantation, loading, follow-up) Description: Ability of DENS to detect clinically meaningful changes across implant treatment phases.
Time frame: Time Frame: Follow up from 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
Convergent Validity Assessment Measure: Correlations between DENS domains and clinical parameters
Time Frame: 3 months post-implantation, 3 and 10 months post-loading Description: Expected correlations r=0.3-0.7 between DENS life impact scores and clinical measures.
Time frame: Time Frame: Follow up from 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
Pathophysiology Periodontal index
Pathophysiology: Bleeding on probing, pocket depth, plaque at 3 months post-implant, 3 and 10 months post-loading
Time frame: Follow up from 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
Surgical Morbidity
Surgical Morbidity: DENS pain/swelling, 5-point Likert (1=Never to 5=Frequently)
Time frame: Time Frame: Follow up at baseline (before implant placement), at 1-2 weeks and 3 months post-implant placement.
Function
Function: DENS chewing/speech, 5-point Likert (1=Never to 5=Always) all timepoints
Time frame: Time Frame: Follow up from 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
Satisfaction Likert Scale
Satisfaction: DENS treatment satisfaction, 5-point Likert (1=Very Dissatisfied to 5=Very Satisfied) all timepoints
Time frame: Time Frame: Follow up from 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
Aesthetics satisfaction
Aesthetics: DENS appearance satisfaction, 5-point Likert (1=Very Dissatisfied to 5=Very Satisfied) at 3 and 10 months post-loading
Time frame: Time Frame: at 3 months and 10 months post-loading of the crown
Quality of Life Likert scale
Quality of Life: DENS life impact, 5-point Likert (1=Never to 5=Always) all timepoints
Time frame: Follow up from 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
Comfort Likert Scale
Comfort: DENS comfort items, 5-point Likert all timepoints
Time frame: Follow up from 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
Implant Survival
Implant Survival: Binary complications through 10 months post-loading
Time frame: Time Frame: 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
Pink Aesthetic score
Pink Aesthetic Score: Professional assessment (0-14) at 3 and 10 months post-loading
Time frame: Time Frame: Follow-up at 3 and 10 months post-loading of the crown
Peri-implant Health
Peri-implant Health: Probing depth, bleeding at 3 months post-implant, 3 and 10 months post-loading
Time frame: Time Frame: 3 months post-implant, 3 and 10 months post-loading of the crown
Plan to share: Undecided — The IPD sharing plan is currently undecided; the protocol is being submitted to BMJ Open.
Started Jun 2024 (actual). Primary completion is estimated for Jun 2027, 35 months after the start.
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