Maxillary Implant Overdentures Retained by Bars or Locator

NCT06152432 | Not Yet Recruiting

• 1 other identifier: 18405
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Edentulous Jaw

Outcome Measures

Primary Outcomes (1)

• Change in peri-implant marginal bone level

  Difference in peri-implant bone level between start of functional period and at 10 years evaluation period

  10 years

Secondary Outcomes (6)

• Implant survival

  10 years

• Overdenture survival

  10 years

• Pocket probing depth

  at 10 years

• Plaque score

  at 10 years

• Peri-implant mucosa condition

  at 10 years

Study Arms (2)

Maxilillary implant overdenture retained by bars

ACTIVE COMPARATOR

Patients treated with 4 dental implants in the edentulous maxilla and an overdenture retained by bars

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)

Device: Maxillary implant overdenture

Interventions

Maxillary implant overdenture DEVICE

Patients with an edentulous maxilla and problems with their conventional denture are treated with an implant overdenture either retained by bars or Locators

Maxilillary implant overdenture retained by Locators; Maxilillary implant overdenture retained by bars

Eligibility Criteria

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

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) 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.

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.

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

Dept Oral and Maxillofacial Surgery UMCG

Groningen, 9713GZ, Netherlands

Location

MeSH Terms

Conditions

Jaw, Edentulous

Condition Hierarchy (Ancestors)

Jaw Diseases; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth, Edentulous; Mouth Diseases; Tooth Diseases

Study Officials

• Henny Meijer, Prof. dr.

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Henny Meijer, Prof. dr.

CONTACT

+31503613840; h.j.a.meijer@umcg.nl

Gerry Raghoebar, Prof. dr.

CONTACT

+31503613840; g.m.raghoebar@umcg.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective comparative study

Study Record Dates

• First Submitted: November 13, 2023
• First Posted: November 30, 2023
• Study Start: October 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 9, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)