Implant-supported Maxillary Overdentures; a 15-years Evaluation

NCT07439237 | Not Yet Recruiting

• 1 other identifier: 15 years maxillary overdenture
• Study Type: observational
• Target: 116
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Edentulous Maxilla, Atrophic; Implants, Dental; Overdenture

Keywords

edentulous maxilla; dental implants; Maxillary overdenture

Outcome Measures

Primary Outcomes (1)

• 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

  Through study completion, an average of 15 years

Secondary Outcomes (6)

• Implant and overdenture survival

  Through study completion, an average of 15 years

• Patient satisfaction

  15 years

• Plaque score

  15 years

• Gingival score

  15 years

• Pocket depth

  15 years

Study Arms (1)

Maxillary overdenture supported by dental implants

Patients with an edentulous maxilla who were provided with dental implants, a bar retention system and an overdenture

Device: Maxillary overdenture supported by dental implants

Interventions

Maxillary overdenture supported by dental implants DEVICE

Maxillary overdenture supported by dental implants

Maxillary overdenture supported by dental implants

Eligibility Criteria

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

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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Center Groningen: lead

Related Publications (2)

• 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.

  PMID: 36122912 BACKGROUND

• Slot 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.

  PMID: 36151932 BACKGROUND

MeSH Terms

Conditions

Atrophic Maxilla

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Maxillary Diseases; Jaw Diseases; Stomatognathic Diseases

Study Officials

• Henny J A Meijer, Professor doctor

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Henny J A Meijer, Professor doctor

CONTACT

+31503616161; h.j.a.meijer@umcg.nl

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 15 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: February 27, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share