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Dens

PROMs in Implant Dentistry: development of a Dental Implant Outcome Set - DENS

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON58290
Enrollment
500
Registered
2025-10-20
Start date
2024-06-01
Completion date
Unknown
Last updated
2026-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

dental implants, tooth implants, dental prosthetic implants, implant-supported restorations permantent tooth replacement, implanted teeth

Interventions

placement of dental implants, and patient-reported outcome measures throughout the treatment process

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: Inadequate oral hygiene, physical inability, pregnancy, a history of radiotherapy in the head and neck region and language barriers are reasons to exclude patients from the study population. Patients who receive soft tissue grafts or need a bone augmentation prior to dental implant placement with harvesting autogenous bone from intraoral are also excluded.

Design outcomes

Primary

MeasureTime frame
The main study parameters include the patient reported outcomes at each timepoint, as well as the clinical reported outcomes assessed after the dental implant placement. Patient reported outcomes consider impact on quality of life, functioning, aesthetics and comfort. The questionnaire is submitted as appendix. Clinician reported outcomes include: visible plaque (yes/no), unrestored carious lesions (yes/no), periodontal health (clinical score), Periodontal health from the implant site and its neighboring teeth is evaluated by bleeding on probing and pocket depth, occurrence and time point of complications

Secondary

MeasureTime frame
All case mix variables assessed at the first time point as well as the characteristics of the implant and prosthesis. The questionnaire is submitted as appendix. Case mix variables include: Age, gender, dental insurance (yes/no), oral hygiene (tooth brushing frequency, interdental cleaning, (reason for) dental visits in the last year, tooth brushing a day), tobacco use, alcohol use (daily vs occasionally) and chronic medical conditions (diabetes, high blood pressure). The questionnaire is submitted as appendix. Characteristics of the implant and prosthesis include: used implant (brand, type) and implant supported crown (single unit fixed dental prosthesis (screw- retained vs cemented)/ multiple unit fixed dental prosthesis/ removable partial denture/ removable full denture).

Countries

Netherlands, Spain

Contacts

Public ContactL Kragt

Erasmus MC, Universitair Medisch Centrum Rotterdam

dens@erasmusmc.nl0107043405

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Mar 14, 2026