Tooth Loss / RehabilitationDENSNCT07337057
DEntal implaNt Set: Development and Implementation of a Standardized Outcome Set in Implant Dentistry
An observational study of Tooth Loss / Rehabilitation, run by Erasmus Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Tooth Loss / Rehabilitation
- What is being tested?
- Implantology
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 1 siteNetherlands
- Study dates
- 24 Jun 2024to 1 Jun 2027
- How long will I take part?
- 18 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Justin Pijpe, MD, DMD, PhD contact
Netherlands1 site, 1 recruiting
- Recruiting
Erasmus Medical Center
Rotterdam, South Holland, 3015 GD
Milton Chin, MD, 83218306 ext. +316, m.chin@erasmusmc.nl
Milton Chin, MD
About this study
Official title: PROMs in Implant Dentistry: Development of a Dental Implant Standard Set
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.
Read more
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.
Read the detailed description
Background and Rationale:
Dental implant treatment success has traditionally been evaluated using clinical parameters such as implant survival, marginal bone loss, and tissue health from the clinician perspective. However, the shift toward value-based healthcare requires integration of patient-reported outcome measures (PROMs) to capture treatment value from the patient's perspective.
The recently published Implant Dentistry Core Outcome Set and Measurement (ID-COSM) international consensus established essential domains for implant research but lacks a validated, clinically feasible patient-reported outcome instrument. Existing dental PROMs like The Oral Health Impact Profile with 14 items are too general for implant-specific evaluation, while comprehensive tools like the ICHOM Adult Oral Health Standard Set are too lengthy for routine clinical use.
Study Design:
This prospective multicenter cohort study develops and validates the Dental Implant Set (DENS), a patient-reported outcome measure based on ID-COSM domains and items extracted from validated instruments (The Oral Health Impact Profile with 14 items, the Psychosocial Impact of Dental Aesthetics Questionnaire, the Patient Satisfaction Questionnaire with 18 items, the Dental Satisfaction Questionnaire, and the Quality of My Facial Questionnaire are used). The DENS captures four core domains: pathophysiology, implant/prosthesis lifespan, life impact, and functional outcomes.
Technical Implementation:
Data collection occurs through an integrated online platform using GemTracker and LimeSurvey. Participating clinics receive secure access credentials and standardized protocols. Patient questionnaires are distributed via secure links prior to appointments, with alternative in-clinic completion available. Clinical data entry occurs immediately post-appointment.
Validation Framework:
Psychometric evaluation includes internal consistency reliability (Cronbach's alpha), construct validity through confirmatory factor analysis, convergent validity via correlations with clinical parameters, and known-groups validity comparing patient subgroups. Test-retest reliability assessment occurs between stable timepoints.
Multicenter Design:
Approximately 30 dental implant clinics across Netherlands and Spain participate, each recruiting 50-60 patients. This design ensures diverse patient populations and practice settings while maintaining standardized data collection protocols through investigator calibration meetings.
Follow-up Schedule:
The study follows natural implant treatment phases with assessments at 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 (mature functional outcomes). This timeline aligns with standard implant care protocols.
Quality Assurance:
Standardization is maintained through investigator calibration, protocol training, and real-time data monitoring. Missing data patterns and completion rates are tracked to assess implementation feasibility. The pseudonymized data structure ensures patient privacy while enabling comprehensive analysis.
Expected Outcomes:
The validated DENS will provide a standardized, clinically feasible tool for routine implant outcome assessment, enabling benchmarking between practices, quality improvement initiatives, and value-based healthcare implementation in implant dentistry.
- Conditions
- Tooth Loss / Rehabilitation
- Being tested
- Implantology
- Keywords
- Dental implants, Patient reported outcome measures, Core outcome set, Implant dentistry, Peri-implant health
- Medical subject headings
- Tooth Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImplantologyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Implant Group | Patients (18 years and older) that require implants for tooth rehabilitation after loss of tooth/teeth.. Receives: Device: Implantology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-reported outcomes measures
- 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.
Measured: 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.
Measured: 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
DENS Questionnaire Validation: Test-Retest Reliability
Measure: Intraclass correlation coefficient (ICC) Time Frame: Between baseline and 1-2 weeks post-implantation (clinically stable period) Description: Temporal stability of DENS scores in patients without complications. Target ICC ≥0.7.
Measured: 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
Responsiveness to Treatment Phases Measure: Effect sizes (Cohen's d) for DENS domain changes Time Frame: Between treatment phases (implantation, loading, follow-up) Description: Ability of DENS to detect clinically meaningful changes across implant treatment phases.
Measured: 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: 3 months post-implantation, 3 and 10 months post-loading Description: Expected correlations r=0.3-0.7 between DENS life impact scores and clinical measures.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start24 Jun 2024
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Tooth Loss / RehabilitationStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 18 Months
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Santiago de Compostela, University Medical Center Groningen
- Responsible party
- Principal investigator, Dr. Justin Pijpe, Erasmus Medical Center
- Investigators
- Eppo B Wolvius, Prof. PhD. DMD. MD., Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07337057
- Sponsor's protocol ID
- MEC-2023-0688
- Other IDs
- 1661-2022
- Acronym
- DENS
- Status last verified
- Jan 2026
- First submitted
- 2 Dec 2025
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The IPD sharing plan is currently undecided; the protocol is being submitted to BMJ Open.
Publications
Wittneben JG, Wismeijer D, Bragger U, Joda T, Abou-Ayash S. Patient-reported outcome measures focusing on aesthetics of implant- and tooth-supported fixed dental prostheses: A systematic review and meta-analysis. Clin Oral Implants Res. 2018 Oct;29 Suppl 16:224-240. doi: 10.1111/clr.13295.
PubMed 30328183van der Meulen MJ, John MT, Naeije M, Lobbezoo F. The Dutch version of the Oral Health Impact Profile (OHIP-NL): Translation, reliability and construct validity. BMC Oral Health. 2008 Apr 11;8:11. doi: 10.1186/1472-6831-8-11.
PubMed 18405359Torrance GW, Feeny D, Furlong W. Visual analog scales: do they have a role in the measurement of preferences for health states? Med Decis Making. 2001 Jul-Aug;21(4):329-34. doi: 10.1177/0272989X0102100408.
PubMed 11475389Tan WC, Krishnaswamy G, Ong MM, Lang NP. Patient-reported outcome measures after routine periodontal and implant surgical procedures. J Clin Periodontol. 2014 Jun;41(6):618-24. doi: 10.1111/jcpe.12248. Epub 2014 Apr 21.
PubMed 24593854Steinmann 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.
PubMed 33846147Slade GD. Derivation and validation of a short-form oral health impact profile. Community Dent Oral Epidemiol. 1997 Aug;25(4):284-90. doi: 10.1111/j.1600-0528.1997.tb00941.x.
PubMed 9332805Ruiz Henao PA, Caneiro Queija L, Mareque S, Tasende Pereira A, Linares Gonzalez A, Blanco Carrion J. Titanium vs ceramic single dental implants in the anterior maxilla: A 12-month randomized clinical trial. Clin Oral Implants Res. 2021 Aug;32(8):951-961. doi: 10.1111/clr.13788. Epub 2021 Jul 8.
PubMed 34061402Riordain RN, Glick M, Mashhadani SSAA, Aravamudhan K, Barrow J, Cole D, Crall JJ, Gallagher JE, Gibson J, Hegde S, Kaberry R, Kalenderian E, Karki A, Celeste RK, Listl S, Myers SN, Niederman R, Severin T, Smith MW, Murray Thomson W, Tsakos G, Vujicic M, Watt RG, Whittaker S, Williams DM. Developing a Standard Set of Patient-centred Outcomes for Adult Oral Health - An International, Cross-disciplinary Consensus. Int Dent J. 2021 Feb;71(1):40-52. doi: 10.1111/idj.12604. Epub 2021 Jan 16.
PubMed 33616051Powell CA, Mealey BL, Deas DE, McDonnell HT, Moritz AJ. Post-surgical infections: prevalence associated with various periodontal surgical procedures. J Periodontol. 2005 Mar;76(3):329-33. doi: 10.1902/jop.2005.76.3.329.
PubMed 15857064Nielsen 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.
PubMed 34866250Montero-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.
PubMed 19114956Mareque 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.
PubMed 34100157Lavrakas, P. J. (2008). Encyclopedia of survey research methods (Vols. 1-0). Thousand Oaks, CA: Sage Publications, Inc.
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.
PubMed 34728252Kragt 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.
PubMed 26331628
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROMs in Implant Dentistry: Development of a Dental Implant Standard Set
- ClinicalTrials.gov ID
- NCT07337057
- Acronym / sponsor ID
- DENS / MEC-2023-0688
- Conditions
- Tooth Loss / Rehabilitation
- Keywords
- Dental implants, Patient reported outcome measures, Core outcome set, Implant dentistry, Peri-implant health
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- University of Santiago de Compostela, University Medical Center Groningen
- Study start
- 24 Jun 2024 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 13 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background and Rationale:
Dental implant treatment success has traditionally been evaluated using clinical parameters such as implant survival, marginal bone loss, and tissue health from the clinician perspective. However, the shift toward value-based healthcare requires integration of patient-reported outcome measures (PROMs) to capture treatment value from the patient's perspective.
The recently published Implant Dentistry Core Outcome Set and Measurement (ID-COSM) international consensus established essential domains for implant research but lacks a validated, clinically feasible patient-reported outcome instrument. Existing dental PROMs like The Oral Health Impact Profile with 14 items are too general for implant-specific evaluation, while comprehensive tools like the ICHOM Adult Oral Health Standard Set are too lengthy for routine clinical use.
Study Design:
This prospective multicenter cohort study develops and validates the Dental Implant Set (DENS), a patient-reported outcome measure based on ID-COSM domains and items extracted from validated instruments (The Oral Health Impact Profile with 14 items, the Psychosocial Impact of Dental Aesthetics Questionnaire, the Patient Satisfaction Questionnaire with 18 items, the Dental Satisfaction Questionnaire, and the Quality of My Facial Questionnaire are used). The DENS captures four core domains: pathophysiology, implant/prosthesis lifespan, life impact, and functional outcomes.
Technical Implementation:
Data collection occurs through an integrated online platform using GemTracker and LimeSurvey. Participating clinics receive secure access credentials and standardized protocols. Patient questionnaires are distributed via secure links prior to appointments, with alternative in-clinic completion available. Clinical data entry occurs immediately post-appointment.
Validation Framework:
Psychometric evaluation includes internal consistency reliability (Cronbach's alpha), construct validity through confirmatory factor analysis, convergent validity via correlations with clinical parameters, and known-groups validity comparing patient subgroups. Test-retest reliability assessment occurs between stable timepoints.
Multicenter Design:
Approximately 30 dental implant clinics across Netherlands and Spain participate, each recruiting 50-60 patients. This design ensures diverse patient populations and practice settings while maintaining standardized data collection protocols through investigator calibration meetings.
Follow-up Schedule:
The study follows natural implant treatment phases with assessments at 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 (mature functional outcomes). This timeline aligns with standard implant care protocols.
Quality Assurance:
Standardization is maintained through investigator calibration, protocol training, and real-time data monitoring. Missing data patterns and completion rates are tracked to assess implementation feasibility. The pseudonymized data structure ensures patient privacy while enabling comprehensive analysis.
Expected Outcomes:
The validated DENS will provide a standardized, clinically feasible tool for routine implant outcome assessment, enabling benchmarking between practices, quality improvement initiatives, and value-based healthcare implementation in implant dentistry.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 18 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implant Group | – | Device: ImplantologyPatients (18 years and older) that require implants for tooth rehabilitation after loss of tooth/teeth.. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- Inadequate oral hygiene
- Physical inability
- Pregnancy
- History of radiotherapy in head and neck region
- Language barriers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ImplantologyImplantology 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. | Device | Implant Group |
Primary outcome
Patient-reported outcomes measures
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
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.
Internal Consistency Reliability
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
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.
3 secondary outcomes
Secondary outcome measures
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
Responsiveness to Treatment Phases Measure: Effect sizes (Cohen's d) for DENS domain changes
Time frame: 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: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Background: PubMed 30328183Wittneben JG, Wismeijer D, Bragger U, Joda T, Abou-Ayash S. Patient-reported outcome measures focusing on aesthetics of implant- and tooth-supported fixed dental prostheses: A systematic review and meta-analysis. Clin Oral Implants Res. 2018 Oct;29 Suppl 16:224-240. doi: 10.1111/clr.13295.
- Background: PubMed 18405359van der Meulen MJ, John MT, Naeije M, Lobbezoo F. The Dutch version of the Oral Health Impact Profile (OHIP-NL): Translation, reliability and construct validity. BMC Oral Health. 2008 Apr 11;8:11. doi: 10.1186/1472-6831-8-11.
- Background: PubMed 11475389Torrance GW, Feeny D, Furlong W. Visual analog scales: do they have a role in the measurement of preferences for health states? Med Decis Making. 2001 Jul-Aug;21(4):329-34. doi: 10.1177/0272989X0102100408.
- Background: PubMed 24593854Tan WC, Krishnaswamy G, Ong MM, Lang NP. Patient-reported outcome measures after routine periodontal and implant surgical procedures. J Clin Periodontol. 2014 Jun;41(6):618-24. doi: 10.1111/jcpe.12248. Epub 2014 Apr 21.
- Background: PubMed 33846147Steinmann 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.
- Background: PubMed 9332805Slade GD. Derivation and validation of a short-form oral health impact profile. Community Dent Oral Epidemiol. 1997 Aug;25(4):284-90. doi: 10.1111/j.1600-0528.1997.tb00941.x.
- Background: PubMed 34061402Ruiz Henao PA, Caneiro Queija L, Mareque S, Tasende Pereira A, Linares Gonzalez A, Blanco Carrion J. Titanium vs ceramic single dental implants in the anterior maxilla: A 12-month randomized clinical trial. Clin Oral Implants Res. 2021 Aug;32(8):951-961. doi: 10.1111/clr.13788. Epub 2021 Jul 8.
- Background: PubMed 33616051Riordain RN, Glick M, Mashhadani SSAA, Aravamudhan K, Barrow J, Cole D, Crall JJ, Gallagher JE, Gibson J, Hegde S, Kaberry R, Kalenderian E, Karki A, Celeste RK, Listl S, Myers SN, Niederman R, Severin T, Smith MW, Murray Thomson W, Tsakos G, Vujicic M, Watt RG, Whittaker S, Williams DM. Developing a Standard Set of Patient-centred Outcomes for Adult Oral Health - An International, Cross-disciplinary Consensus. Int Dent J. 2021 Feb;71(1):40-52. doi: 10.1111/idj.12604. Epub 2021 Jan 16.
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- Website for patients and clinicians for information regarding the DENS studyLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. The IPD sharing plan is currently undecided; the protocol is being submitted to BMJ Open.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Justin Pijpe, MD, DMD, PhD contact
Eppo B Wolvius, Prof. PhD. DMD. MD. principal investigator
Erasmus Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tooth Loss / Rehabilitation, run by Erasmus Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Milton Chin, MD (83218306 ext. +316, m.chin@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-reported outcomes measures (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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07337057, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.