A standardized outcome set to measure results of dental implants (DENS).
PROMs in Implant Dentistry: Development of a Dental Implant Standard Set
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 |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Erasmus Medical Center Academic / other |
| Locations | 1 site (Rotterdam, South Holland) |
| Trial ID | NCT07337057 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Rotterdam, South Holland
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.