Edentulous Maxilla, AtrophicNCT07439237
Implant-supported Maxillary Overdentures; a 15-years Evaluation
An observational study of Edentulous Maxilla, Atrophic and Implants, Dental, run by University Medical Center Groningen.
Trial summary
Background Patients experiencing problems with their conventional maxillary denture can benefit from implant- retained overdentures. Bar-retained implant overdentures can be supported by 4 or 6 implants, splinted by a bar. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Edentulous Maxilla, Atrophic, Implants, Dental, Overdenture
- What is being tested?
- Maxillary overdenture supported by dental implants
- Type of treatment
- Medical device
- How many people
- 116 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 1 Nov 2026
- How long will I take part?
- 15 Years
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who were treated 15 years ago with dental implants and an overdenture in the maxilla because of problems with retention and stability with their maxillary conventional denture.
Who may be able to join
- Fully edentulous patients or patients with an overdenture in the mandible, who were referred to the Department of Oral and Maxillofacial Surgery (University Medical Center Groningen, the Netherlands) 15 years ago, because they suffered from a lack of retention and stability of the upper denture;
- At the time of treatment:
- Edentulous in the maxilla for at least one year;
- Sufficient bone volume in height in the anterior or posterior region of the maxilla to place the implants;
- The patient was 18 years or older;
- Sufficient interocclusal space for placement of an overdenture with attachment system;
- The patient was capable of understanding and giving informed consent.
Who cannot join
- Patients with American Society of Anesthesiologists score (ASA score) ≥ III;
- Patients who were smoking;
- Patients with a history of radiotherapy in the head and neck region;
- Patients with a history of pre-prosthetic surgery or previous implant placement in the maxilla.
- None
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
- Background Patients experiencing problems with their conventional maxillary denture can benefit from implant- retained overdentures. Bar-retained implant overdentures can be supported by 4 or 6 implants, splinted by a bar. Evidence on maxillary implant overdentures has been mostly short to medium term, non-comparing or retrospective. Even more, 15-years data of comparative studies are lacking. It is important to evaluate treatment outcomes, such as implant survival, peri-implant bone changes and patient satisfaction at the long-term.
- Main research question The aim of this 15-years study is to evaluate a patient group treated 15 years ago in a prospective study with a maxillary overdenture on 4 or 6 implants in an edentulous maxilla. The primary objective of the study is to analyze marginal bone level changes by radiological assessments at 15-years follow-up. Secondary objectives are implant and overdenture survival, condition of peri- implant mucosa and patients' satisfaction.
- Design (including population, confounders/outcomes) The study design is an observational study of a group of patients which were treated 15 years ago with dental implants and an overdenture in the maxilla because of problems with retention and stability with their conventional denture. Outcomes: primary outcome is the change in marginal peri-implant bone level 15 years after placing the overdenture. Secondary outcome measures will be implant and overdenture survival, peri-implant mucosa health and patients' satisfaction using a questionnaire.
- Expected results Stable peri-implant bone levels, high implant and overdenture survival rate and satisfied patients.
Read the detailed description
- Introduction and rationale In patients who present persistent complaints with respect to their maxillary denture, providing implant support improves comfort, denture satisfaction and overall quality of life considerably and high implant survival rates are reported. Implant position, the number of implants and bone volume are all factors that presumably influence success of both the maxillary overdenture and the implants.
Four- and 6-implant bar-supported maxillary overdenture studies report successful short and medium-term results, indicating that these treatment modalities are comparable and favourable. However, there is considerable heterogeneity with respect to patient and treatment variables within studies reporting on maxillary overdentures in general and four versus six implants in particular, with a lack of high quality long term data as well.
The aim of the present study is to report long term results of bar-supported maxillary implant overdentures on four and six anterior implants for which various clinical surgical and prosthetic outcome measures and subjective, patient-reported parameters are described and compared. Evidence on maxillary IOD attachment systems has been mostly short to medium term, non-comparing or retrospective and therefore inconclusive. This underlines the need for studies comparing different attachment systems with a longer follow-up.
The study design is an observational study to compare treatment outcomes of fully edentulous patients with maxillary IODs, supported by four or six implants. Patients were treated 15 years ago with dental implants and an overdenture in the maxilla because of problems with retention and stability with their conventional denture. Outcomes: primary outcome is the change in marginal peri-implant bone level 15 years after placing the overdenture. Secondary outcome measures will be implant and overdenture survival, peri-implant mucosa health and patients' satisfaction using a questionnaire.
- Conditions
- Edentulous Maxilla, Atrophic, Implants, Dental, Overdenture
- Being tested
- Maxillary overdenture supported by dental implants
- Keywords
- edentulous maxilla, dental implants, Maxillary overdenture
- Medical subject headings
- Atrophic Maxilla
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maxillary overdenture supported by dental implantsDevice
Maxillary overdenture supported by dental implants
| Study group | Role | What they receive |
|---|---|---|
| Maxillary overdenture supported by dental implants | Patients with an edentulous maxilla who were provided with dental implants, a bar retention system and an overdenture Receives: Device: Maxillary overdenture supported by dental implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in peri-implant marginal bone level
Comparison between peri-implant bone level at overdenture placement and follow-up time point in millimeters measured on intraoral radiograph
Measured: Through study completion, an average of 15 years
Secondary outcomes (6)
Implant and overdenture survival
Percentage of implants and overdentures present at follow-up time point
Measured: Through study completion, an average of 15 years
Patient satisfaction
Patient satisfaction measured on a Visual Analogue Scale. Minimum =0 (extremely dissatisfied); Maximum = 100 (extremely satisfied)
Measured: 15 years
Plaque score
Plaque index from 0 to 3. Minimum = 0 (zero plaque visible); Maximum = 3 (abundant amount of plaque visible)
Measured: 15 years
Gingival score
Health of peri-implant mucosa described by Gingival index from 0 to 3. Minimum = 0 (healthy mucosa); Maximum = 3 (very infected mucosa)
Measured: 15 years
Pocket depth
Probing depth in the peri-implant sulcus in millimeters measured with a periodontal probe
Measured: 15 years
Bleeding score
Bleeding in peri-implant sulcus after probing measured with a Bleeding index from 0 to 3. Minimum = 0 (no bleeding after probing); Maximum = 3 (abundance amount of bleeding after probing)
Measured: 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start1 May 2026 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Edentulous Maxilla, AtrophicStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 116 participants (estimated)
- Target duration
- 15 Years
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Henny J A Meijer, Professor doctor, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07439237
- Sponsor's protocol ID
- 15 years maxillary overdenture
- Status last verified
- Feb 2026
- First submitted
- 23 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Slot W, Raghoebar GM, Cune MS, Vissink A, Meijer HJA. Maxillary overdentures supported by four or six implants in the anterior region: 10-year randomized controlled trial results. J Clin Periodontol. 2023 Jan;50(1):36-44. doi: 10.1111/jcpe.13726. Epub 2022 Oct 7.
PubMed 36122912Slot W, Raghoebar GM, Cune MS, Vissink A, Meijer HJA. Maxillary bar overdentures on four or six posterior implants: 10-year results from a randomized clinical trial. Clin Oral Implants Res. 2022 Nov;33(11):1147-1156. doi: 10.1111/clr.13997. Epub 2022 Sep 29.
PubMed 36151932
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implant-supported Maxillary Overdentures; a 15-years Evaluation
- ClinicalTrials.gov ID
- NCT07439237
- Acronym / sponsor ID
- 15 years maxillary overdenture
- Conditions
- Edentulous Maxilla, Atrophic, Implants, Dental, Overdenture
- Keywords
- edentulous maxilla, dental implants, Maxillary overdenture
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 27 Feb 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.
- Background Patients experiencing problems with their conventional maxillary denture can benefit from implant- retained overdentures. Bar-retained implant overdentures can be supported by 4 or 6 implants, splinted by a bar. Evidence on maxillary implant overdentures has been mostly short to medium term, non-comparing or retrospective. Even more, 15-years data of comparative studies are lacking. It is important to evaluate treatment outcomes, such as implant survival, peri-implant bone changes and patient satisfaction at the long-term.
- Main research question The aim of this 15-years study is to evaluate a patient group treated 15 years ago in a prospective study with a maxillary overdenture on 4 or 6 implants in an edentulous maxilla. The primary objective of the study is to analyze marginal bone level changes by radiological assessments at 15-years follow-up. Secondary objectives are implant and overdenture survival, condition of peri- implant mucosa and patients' satisfaction.
- Design (including population, confounders/outcomes) The study design is an observational study of a group of patients which were treated 15 years ago with dental implants and an overdenture in the maxilla because of problems with retention and stability with their conventional denture. Outcomes: primary outcome is the change in marginal peri-implant bone level 15 years after placing the overdenture. Secondary outcome measures will be implant and overdenture survival, peri-implant mucosa health and patients' satisfaction using a questionnaire.
- Expected results Stable peri-implant bone levels, high implant and overdenture survival rate and satisfied patients.
Detailed description
- Introduction and rationale In patients who present persistent complaints with respect to their maxillary denture, providing implant support improves comfort, denture satisfaction and overall quality of life considerably and high implant survival rates are reported. Implant position, the number of implants and bone volume are all factors that presumably influence success of both the maxillary overdenture and the implants.
Four- and 6-implant bar-supported maxillary overdenture studies report successful short and medium-term results, indicating that these treatment modalities are comparable and favourable. However, there is considerable heterogeneity with respect to patient and treatment variables within studies reporting on maxillary overdentures in general and four versus six implants in particular, with a lack of high quality long term data as well.
The aim of the present study is to report long term results of bar-supported maxillary implant overdentures on four and six anterior implants for which various clinical surgical and prosthetic outcome measures and subjective, patient-reported parameters are described and compared. Evidence on maxillary IOD attachment systems has been mostly short to medium term, non-comparing or retrospective and therefore inconclusive. This underlines the need for studies comparing different attachment systems with a longer follow-up.
The study design is an observational study to compare treatment outcomes of fully edentulous patients with maxillary IODs, supported by four or six implants. Patients were treated 15 years ago with dental implants and an overdenture in the maxilla because of problems with retention and stability with their conventional denture. Outcomes: primary outcome is the change in marginal peri-implant bone level 15 years after placing the overdenture. Secondary outcome measures will be implant and overdenture survival, peri-implant mucosa health and patients' satisfaction using a questionnaire.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 15 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Maxillary overdenture supported by dental implants | – | Device: Maxillary overdenture supported by dental implantsPatients with an edentulous maxilla who were provided with dental implants, a bar retention system and an overdenture |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who were treated 15 years ago with dental implants and an overdenture in the maxilla because of problems with retention and stability with their maxillary conventional denture.
Key inclusion criteria (7 listed)
- Fully edentulous patients or patients with an overdenture in the mandible, who were referred to the Department of Oral and Maxillofacial Surgery (University Medical Center Groningen, the Netherlands) 15 years ago, because they suffered from a lack of retention and stability of the upper denture;
- Edentulous in the maxilla for at least one year;
- Sufficient bone volume in height in the anterior or posterior region of the maxilla to place the implants;
- The patient was 18 years or older;
- Sufficient interocclusal space for placement of an overdenture with attachment system;
Key exclusion criteria (5 listed)
- Patients with American Society of Anesthesiologists score (ASA score) ≥ III;
- Patients who were smoking;
- Patients with a history of radiotherapy in the head and neck region;
- Patients with a history of pre-prosthetic surgery or previous implant placement in the maxilla.
- None
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 |
|---|---|---|
| Maxillary overdenture supported by dental implantsMaxillary overdenture supported by dental implants | Device | Maxillary overdenture supported by dental implants |
Primary outcome
Change in peri-implant marginal bone level
Time frame: Through study completion, an average of 15 years
Comparison between peri-implant bone level at overdenture placement and follow-up time point in millimeters measured on intraoral radiograph
6 secondary outcomes
Implant and overdenture survival
Time frame: Through study completion, an average of 15 years
Patient satisfaction
Time frame: 15 years
Plaque score
Time frame: 15 years
Gingival score
Time frame: 15 years
Pocket depth
Time frame: 15 years
Bleeding score
Time frame: 15 years
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 27 Feb 2026.
- Background: PubMed 36122912Slot W, Raghoebar GM, Cune MS, Vissink A, Meijer HJA. Maxillary overdentures supported by four or six implants in the anterior region: 10-year randomized controlled trial results. J Clin Periodontol. 2023 Jan;50(1):36-44. doi: 10.1111/jcpe.13726. Epub 2022 Oct 7.
- Background: PubMed 36151932Slot W, Raghoebar GM, Cune MS, Vissink A, Meijer HJA. Maxillary bar overdentures on four or six posterior implants: 10-year results from a randomized clinical trial. Clin Oral Implants Res. 2022 Nov;33(11):1147-1156. doi: 10.1111/clr.13997. Epub 2022 Sep 29.
- Individual participant dataSharing planned: No
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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.
Henny J A Meijer, Professor doctor principal investigator
University Medical Center Groningen
Questions about this trial
What is this clinical trial studying?
An observational study of Edentulous Maxilla, Atrophic and Implants, Dental, run by University Medical Center Groningen.
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 7 inclusion and 5 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: opening soon, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Henny J A Meijer, Professor doctor (+31503616161, h.j.a.meijer@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in peri-implant marginal bone level (time frame: Through study completion, an average of 15 years). 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 NCT07439237, which also lists 2 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 27 Feb 2026.