A standardized outcome set to measure results of dental implants (DENS).
Official title: PROMs in Implant Dentistry: Development of a Dental Implant Standard Set
Run by Erasmus Medical Center · NCT07337057 · Data updated 2026-11-12
This project will test a short patient questionnaire (DENS) to see if it captures outcomes that matter to adults getting dental implants.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 1000 (estimated) |
| Sponsor | Erasmus Medical Center Academic / other |
| Locations | 1 site (Rotterdam, South Holland) |
| Status | Recruiting |
| Started | June 24, 2024 |
| Main results expected | June 1, 2027 |
| Study ends | June 1, 2027 |
| Registry record updated | January 13, 2026 |
| Trial ID | NCT07337057 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–70 who are scheduled for implant-supported fixed or removable tooth replacement, including immediate placement and implants after prior implant failure, are ideal candidates.
✕Probably not a fit
People with inadequate oral hygiene, need for pre-implant soft tissue grafting or autogenous intraoral bone harvesting, recent head and neck radiotherapy, pregnancy, physical inability, or language barriers are excluded and likely would not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective multicenter cohort effort to develop and validate the Dental Implant Set (DENS), a brief patient-reported outcome measure built from items of established dental questionnaires and the international ID-COSM core domains. Participants receiving implant-supported fixed or removable tooth replacements will complete DENS alongside routine clinical measures including implant survival, peri-implant tissue health, and radiographic bone changes. The study will examine reliability, validity, responsiveness, and clinical feasibility of DENS for use in routine care. Implementation aims to combine patient-reported and clinical outcomes to support value-based decision making and quality improvement in implant dentistry.
Why it matters
Potential benefit: If successful, DENS could give dentists and patients a short, validated way to track implant outcomes that reflects both clinical results and patient experience, improving shared decision making and care quality.
How similar studies have gone: International consensus work (ID-COSM) defined core domains and prior PROMs exist, but a short, validated implant-specific PROM like DENS is relatively novel and has not yet been widely validated.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18-70 years * Indication for implant-supported fixed single or multiple tooth replacement * Indication for implant-supported removable prosthesis * Immediate implant placement cases * Implant placement after implant failure Exclusion Criteria: * Inadequate oral hygiene * Physical inability * Pregnancy * History of radiotherapy in head and neck region * Language barriers * Patients requiring soft tissue grafts prior to dental implant placement * Patients requiring bone augmentation with harvesting autogenous bone from intraoral sites prior to dental implant placement
Where it's running
-
Erasmus Medical Center
Rotterdam, South Holland, Netherlands Recruiting
Study contacts
- Principal investigator: Eppo B Wolvius, Prof. PhD. DMD. MD. — Erasmus Medical Center
- Study coordinator: Milton Chin, MD
- Email: m.chin@erasmusmc.nl
- Phone: 83218306
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.