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

NCT07337057 | Recruiting DMC

• 2 other identifiers: MEC-2023-06881661-2022
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Dental implants; Patient reported outcome measures; Core outcome set; Implant dentistry; Peri-implant health

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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 Outcomes (3)

• Secondary outcome measures

  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

  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: 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

Other Outcomes (10)

• Pathophysiology Periodontal index

  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

  Time Frame: Follow up at baseline (before implant placement), at 1-2 weeks and 3 months post-implant placement.

• Function

  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

Study Arms (1)

Implant Group

Patients (18 years and older) that require implants for tooth rehabilitation after loss of tooth/teeth..

Device: Implantology

Interventions

Implantology DEVICE

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.

Implant Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Erasmus Medical Center: lead
• University of Santiago de Compostela: collaborator
• University Medical Center Groningen: collaborator

Study Sites (1)

Erasmus Medical Center

Rotterdam, South Holland, 3015 GD, Netherlands

RECRUITING

Related Publications (20)

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• Steinmann G, Delnoij D, van de Bovenkamp H, Groote R, Ahaus K. Expert consensus on moving towards a value-based healthcare system in the Netherlands: a Delphi study. BMJ Open. 2021 Apr 12;11(4):e043367. doi: 10.1136/bmjopen-2020-043367.

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• Nielsen HB, Schou S, Bruun NH, Starch-Jensen T. Professional and patient-reported outcomes of two surgical approaches for implant-supported single-crown restoration: 1-year results of a randomized controlled clinical trial. Clin Oral Implants Res. 2022 Feb;33(2):197-208. doi: 10.1111/clr.13883. Epub 2021 Dec 17.

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• Montero-Martin J, Bravo-Perez M, Albaladejo-Martinez A, Hernandez-Martin LA, Rosel-Gallardo EM. Validation the Oral Health Impact Profile (OHIP-14sp) for adults in Spain. Med Oral Patol Oral Cir Bucal. 2009 Jan 1;14(1):E44-50.

  PMID: 19114956 BACKGROUND

• Mareque S, Castelo-Baz P, Lopez-Malla J, Blanco J, Nart J, Valles C. Clinical and esthetic outcomes of immediate implant placement compared to alveolar ridge preservation: a systematic review and meta-analysis. Clin Oral Investig. 2021 Aug;25(8):4735-4748. doi: 10.1007/s00784-021-03986-6. Epub 2021 Jun 7.

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  BACKGROUND

• Kunavisarut C, Jarangkul W, Pornprasertsuk-Damrongsri S, Joda T. Patient-reported outcome measures (PROMs) comparing digital and conventional workflows for treatment with posterior single-unit implant restorations: A randomized controlled trial. J Dent. 2022 Feb;117:103875. doi: 10.1016/j.jdent.2021.103875. Epub 2021 Oct 30.

  PMID: 34728252 BACKGROUND

• Kragt L, Tiemeier H, Wolvius EB, Ongkosuwito EM. Measuring oral health-related quality of life in orthodontic patients with a short version of the Child Oral Health Impact Profile (COHIP). J Public Health Dent. 2016 Mar;76(2):105-12. doi: 10.1111/jphd.12118. Epub 2015 Sep 2.

  PMID: 26331628 BACKGROUND

• Kragt L, Jaddoe V, Wolvius E, Ongkosuwito E. The association of subjective orthodontic treatment need with oral health-related quality of life. Community Dent Oral Epidemiol. 2017 Aug;45(4):365-371. doi: 10.1111/cdoe.12299. Epub 2017 Mar 31.

  PMID: 28370341 BACKGROUND

• Jonker BP, Wolvius EB, van der Tas JT, Tahmaseb A, Pijpe J. Esthetics and Patient-Reported Outcomes of Implants Placed with Guided Bone Regeneration and Complete Native Bone: A Prospective Controlled Clinical Trial. Int J Oral Maxillofac Implants. 2020 Mar/Apr;35(2):406-414. doi: 10.11607/jomi.7751.

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• Jensen C, Raghoebar GM, Kerdijk W, Meijer HJA, Cune MS. Implant-supported mandibular removable partial dentures; patient-based outcome measures in relation to implant position. J Dent. 2016 Dec;55:92-98. doi: 10.1016/j.jdent.2016.10.008. Epub 2016 Oct 18.

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• Feine J, Abou-Ayash S, Al Mardini M, de Santana RB, Bjelke-Holtermann T, Bornstein MM, Braegger U, Cao O, Cordaro L, Eycken D, Fillion M, Gebran G, Huynh-Ba G, Joda T, Levine R, Mattheos N, Oates TW, Abd-Ul-Salam H, Santosa R, Shahdad S, Storelli S, Sykaras N, Trevino Santos A, Stephanie Webersberger U, Williams MAH, Wilson TG Jr, Wismeijer D, Wittneben JG, Yao CJ, Zubiria JPV. Group 3 ITI Consensus Report: Patient-reported outcome measures associated with implant dentistry. Clin Oral Implants Res. 2018 Oct;29 Suppl 16:270-275. doi: 10.1111/clr.13299.

  PMID: 30328187 BACKGROUND

• Tonetti MS, Sanz M, Avila-Ortiz G, Berglundh T, Cairo F, Derks J, Figuero E, Graziani F, Guerra F, Heitz-Mayfield L, Jung RE, Lai H, Needleman I, Papapanou PN, Sailer I, Sanz-Sanchez I, Schwarz F, Shi J, Thoma D. Relevant domains, core outcome sets and measurements for implant dentistry clinical trials: The Implant Dentistry Core Outcome Set and Measurement (ID-COSM) international consensus report. J Clin Periodontol. 2023 May;50 Suppl 25:5-21. doi: 10.1111/jcpe.13808. Epub 2023 May 4.

  PMID: 37143289 BACKGROUND

Related Links

• Website for patients and clinicians for information regarding the DENS study

MeSH Terms

Conditions

Tooth Loss

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Study Officials

• Eppo B Wolvius, Prof. PhD. DMD. MD.

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Milton Chin, MD

CONTACT

83218306; m.chin@erasmusmc.nl

Justin Pijpe, MD, DMD, PhD

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 18 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Oral Maxillofacial Surgery Department

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: January 13, 2026
• Study Start: June 24, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: January 13, 2026

Record last verified: 2026-01

Locations

NL (1)