Edentulous JawNCT06152432
Maxillary Implant Overdentures Retained by Bars or Locator
A study testing Maxillary implant overdenture in people with Edentulous Jaw, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
Background Patients experiencing problems with their conventional maxillary denture can benefit from implant- retained overdentures. Several retention systems are available. These retention systems can be roughly divided into bar-retained implant overdentures, in which multiple implants are splinted and the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Edentulous Jaw
- What is being tested?
- Maxillary implant overdenture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Oct 2024to 31 Dec 2027
- Phase
- Interventional
- 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
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) 10 years ago, because they suffered from a lack of retention and stability of the upper (and lower) denture;
- Edentulous in the maxilla for at least one year;
- Sufficient bone volume in height in the anterior 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site
Dept Oral and Maxillofacial Surgery UMCG
Groningen, 9713GZ
About this study
Official title: Maxillary Implant Overdentures Retained by Bars or Locator Attachments: a 10-year Comparative Prospective Study.
- Background Patients experiencing problems with their conventional maxillary denture can benefit from implant- retained overdentures. Several retention systems are available. These retention systems can be roughly divided into bar-retained implant overdentures, in which multiple implants are splinted and the overdenture is attached through retentive clips, and into retention systems using non-splinted solitary attachments (locators). Evidence on maxillary implant overdenture attachment systems has been mostly short to medium term, non-comparing or retrospective. Even more, 10-years data of comparative studies are lacking.
- Main research question To compare treatment outcomes of fully edentulous patients with maxillary overdentures, supported by four implants, retained by either bars or locators . The primary objective of the study is to analyze marginal bone level changes by radiological assessments at 10-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 10 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 10 years after placing the overdenture. Secondary outcome measures will be implant and overdenture survival, peri-implant mucosa health and patients' satisfaction using a questionnaire.
Read the detailed description
- Introduction and rationale Patients experiencing problems with their conventional maxillary denture can benefit from implant-retained overdentures (IODs). Several retention systems are available. These retention systems can be roughly divided into bar-retained IODs, in which multiple implants are splinted and the overdenture is attached through retentive clips, and into retention systems using non-splinted solitary attachments. Bar-retained IOD's provide good retention, require little maintenance, but are more expensive than solitary attachments. Medium term results of bar-retained IODs are promising with high implant and overdenture survival and low incidence of complications and may be considered the gold standard. Solitary attachments serve as an alternative to bars. These attachments are more economical and are easy to clean by the patient, but wear more easily, which can cause lack of retention. However, replacement of these attachments can often be done chair side. A recent review reported that, when a maxillary IOD is supported by four implants, both types show equal implant survival, overdenture survival and patient satisfaction. However, these conclusions are based on a limited amount of randomized controlled trials. Moreover, most studies reporting on solitary attachments were retrospective. 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 implants, retained by either bars or Locators. Patients were treated 10 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 10 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 Jaw
- Being tested
- Maxillary implant overdenture
- Medical subject headings
- Jaw, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maxillary implant overdentureDevice
Patients with an edentulous maxilla and problems with their conventional denture are treated with an implant overdenture either retained by bars or Locators
| Study group | Role | What they receive |
|---|---|---|
| Maxilillary implant overdenture retained by bars | Active comparator | Patients treated with 4 dental implants in the edentulous maxilla and an overdenture retained by bars Receives: Device: Maxillary implant overdenture |
| Maxilillary implant overdenture retained by Locators | Active comparator | Patients treated with 4 dental implants in the edentulous maxilla and an overdenture retained by solitary abutments (Locators) Receives: Device: Maxillary implant overdenture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in peri-implant marginal bone level
Difference in peri-implant bone level between start of functional period and at 10 years evaluation period
Measured: 10 years
Secondary outcomes (6)
Implant survival
Percentage of number of initially placed implants still in place after 10 years
Measured: 10 years
Overdenture survival
Percentage of number of initially placed overdentures still in place after 10 years
Measured: 10 years
Pocket probing depth
Depth in millimeter of probing in the peri-implant sulcus
Measured: at 10 years
Plaque score
Amount of plaque on implant abutment scored with the Modified Plaque Index, score 0-3, 3 is the worst
Measured: at 10 years
Peri-implant mucosa condition
Health of peri-implant mucosa scored wit a Gingiva Index, score 0-3, 3 is the worst
Measured: at 10 years
Patient satisfaction
Satisfaction of patients scored with a 5-point Likert scale, score 1-5, 5 is most dissatisfied
Measured: at 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2023
- Study start1 Oct 2024 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulous JawStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Prospective comparative study
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Henny Meijer, Prof. dr., Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06152432
- Sponsor's protocol ID
- 18405
- Status last verified
- May 2024
- First submitted
- 13 Nov 2023
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maxillary Implant Overdentures Retained by Bars or Locator Attachments: a 10-year Comparative Prospective Study.
- ClinicalTrials.gov ID
- NCT06152432
- Acronym / sponsor ID
- 18405
- Conditions
- Edentulous Jaw
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 30 Nov 2023 (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. Several retention systems are available. These retention systems can be roughly divided into bar-retained implant overdentures, in which multiple implants are splinted and the overdenture is attached through retentive clips, and into retention systems using non-splinted solitary attachments (locators). Evidence on maxillary implant overdenture attachment systems has been mostly short to medium term, non-comparing or retrospective. Even more, 10-years data of comparative studies are lacking.
- Main research question To compare treatment outcomes of fully edentulous patients with maxillary overdentures, supported by four implants, retained by either bars or locators . The primary objective of the study is to analyze marginal bone level changes by radiological assessments at 10-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 10 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 10 years after placing the overdenture. Secondary outcome measures will be implant and overdenture survival, peri-implant mucosa health and patients' satisfaction using a questionnaire.
Detailed description
- Introduction and rationale Patients experiencing problems with their conventional maxillary denture can benefit from implant-retained overdentures (IODs). Several retention systems are available. These retention systems can be roughly divided into bar-retained IODs, in which multiple implants are splinted and the overdenture is attached through retentive clips, and into retention systems using non-splinted solitary attachments. Bar-retained IOD's provide good retention, require little maintenance, but are more expensive than solitary attachments. Medium term results of bar-retained IODs are promising with high implant and overdenture survival and low incidence of complications and may be considered the gold standard. Solitary attachments serve as an alternative to bars. These attachments are more economical and are easy to clean by the patient, but wear more easily, which can cause lack of retention. However, replacement of these attachments can often be done chair side. A recent review reported that, when a maxillary IOD is supported by four implants, both types show equal implant survival, overdenture survival and patient satisfaction. However, these conclusions are based on a limited amount of randomized controlled trials. Moreover, most studies reporting on solitary attachments were retrospective. 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 implants, retained by either bars or Locators. Patients were treated 10 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 10 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective comparative study
| Arm | Type | Receives |
|---|---|---|
| Maxilillary implant overdenture retained by bars | Active comparator | Device: Maxillary implant overdenturePatients treated with 4 dental implants in the edentulous maxilla and an overdenture retained by bars |
| Maxilillary implant overdenture retained by Locators | Active comparator | Device: Maxillary implant overdenturePatients treated with 4 dental implants in the edentulous maxilla and an overdenture retained by solitary abutments (Locators) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 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) 10 years ago, because they suffered from a lack of retention and stability of the upper (and lower) denture;
- Edentulous in the maxilla for at least one year;
- Sufficient bone volume in height in the anterior 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 (4 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.
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 implant overdenturePatients with an edentulous maxilla and problems with their conventional denture are treated with an implant overdenture either retained by bars or Locators | Device | Maxilillary implant overdenture retained by Locators, Maxilillary implant overdenture retained by bars |
Primary outcome
Change in peri-implant marginal bone level
Time frame: 10 years
Difference in peri-implant bone level between start of functional period and at 10 years evaluation period
6 secondary outcomes
Implant survival
Time frame: 10 years
Overdenture survival
Time frame: 10 years
Pocket probing depth
Time frame: at 10 years
Plaque score
Time frame: at 10 years
Peri-implant mucosa condition
Time frame: at 10 years
Patient satisfaction
Time frame: at 10 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 9 May 2024.
- Individual participant dataSharing planned: No
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Digital and Conventional Clasp-retained Partial Dentures (DIGICLASP)
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Chewing Efficiency in Completely Edentulous Patients Rehabilitated With Implant-Supported Full-Arch Prostheses
Active, not recruiting
Multicenter Study to Evaluate the Clinical Outcome of PrimeTaper EV Implant in Single Tooth Restorations
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Clinical and Radiographic Evaluation of UV-Treated Dental Implants With or Without Melatonin in the Upper Posterior Jaw
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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 Meijer, Prof. dr. principal investigator
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maxillary implant overdenture in people with Edentulous Jaw, run by University Medical Center Groningen 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 6 inclusion and 4 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 9 May 2024. 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 Henny Meijer, Prof. dr. (+31503613840, 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: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 May 2024.