About this trial
* 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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 design
Parallel
Treatments tested in this trial
Maxillary implant overdenture
DevicePatients with an edentulous maxilla and problems with their conventional denture are treated with an implant overdenture either retained by bars or Locators
Treatment groups
Trial outcomes
Primary outcomes
Change in peri-implant marginal bone level
Difference in peri-implant bone level between start of functional period and at 10 years evaluation period
Secondary outcomes
Implant survival
Percentage of number of initially placed implants still in place after 10 years
Overdenture survival
Percentage of number of initially placed overdentures still in place after 10 years
Pocket probing depth
Depth in millimeter of probing in the peri-implant sulcus
Plaque score
Amount of plaque on implant abutment scored with the Modified Plaque Index, score 0-3, 3 is the worst
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: