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NCT06152432

Maxillary Implant Overdentures Retained by Bars or Locator

Not yet recruiting NA Last updated 9 May 2024
What this trial tests

NA trial testing Maxillary implant overdenture in Edentulous Jaw in 50 participants. Not yet recruiting.

Timeline
1 October 2024
Primary endpoint
31 December 2026
31 December 2027

Quick facts

Lead sponsorUniversity Medical Center Groningen
PhaseNA
StatusNot yet recruiting
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment50
Start date1 October 2024
Primary completion31 December 2026
Estimated completion31 December 2027
Sites1 location across Netherlands

Drugs / interventions tested

Conditions studied

Sponsor

University Medical Center Groningen

Who can join

18 and older, any sex, with Edentulous Jaw. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

* 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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of Maxillary implant overdenture

Trials testing the same drug.

Other recruiting trials for Edentulous Jaw

Currently open trials in the same condition.

Other University Medical Center Groningen trials

Trials by the same sponsor.

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Data sources for this page

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