DEntal implaNt Set: Development and Implementation of a Standardized Outcome Set in Implant Dentistry

Summary

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.

Conditions

• Tooth Loss / Rehabilitation

Interventions

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.

Sponsors & Collaborators

• University of Santiago de Compostela

  collaborator OTHER

• University Medical Center Groningen

  collaborator OTHER

• Erasmus Medical Center

  lead OTHER

Principal Investigators

• Eppo B Wolvius, Prof. PhD. DMD. MD. · Erasmus Medical Center

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-06-24

Primary Completion

2027-06-01

Completion

2027-06-01

Countries

• Netherlands

Study Locations