Dept Oral and Maxillofacial Surgery UMCG
Groningen, 9713GZ, Netherlands
NCT Number: NCT06152432
* 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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Groningen, 9713GZ, Netherlands
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Exclusion criteria
at the time of treatment:
Patients with an edentulous maxilla and problems with their conventional denture are treated with an implant overdenture either retained by bars or Locators
Time frame: 10 years
Difference in peri-implant bone level between start of functional period and at 10 years evaluation period
Time frame: 10 years
Percentage of number of initially placed implants still in place after 10 years
Time frame: 10 years
Percentage of number of initially placed overdentures still in place after 10 years
Time frame: at 10 years
Depth in millimeter of probing in the peri-implant sulcus
Time frame: at 10 years
Amount of plaque on implant abutment scored with the Modified Plaque Index, score 0-3, 3 is the worst
Time frame: at 10 years
Health of peri-implant mucosa scored wit a Gingiva Index, score 0-3, 3 is the worst
Time frame: at 10 years
Satisfaction of patients scored with a 5-point Likert scale, score 1-5, 5 is most dissatisfied
Contact information is provided by the study sponsor or research team.
Gerry Raghoebar, Prof. dr.
CONTACT
Henny Meijer, Prof. dr.
CONTACT
University Medical Center Groningen
Other
Maxillary Implant Overdentures Retained by Bars or Locator Attachments: a 10-year Comparative Prospective Study.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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