Ignite Creation Date:
2024-05-06 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06152432
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-09
First Post:
2023-11-13
Brief Title:
Maxillary Implant Overdentures Retained by Bars or Locator
Sponsor:
University Medical Center Groningen
Organization:
University Medical Center Groningen
Study Overview
Official Title:
Maxillary Implant Overdentures Retained by Bars or Locator Attachments a 10-year Comparative Prospective Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 confoundersoutcomes 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
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 confoundersoutcomes 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
Detailed Description:
Introduction and rationale Patients experiencing problems with their conventional maxillary denture can benefit from implant-retained overdentures IODs Several retention systems are available These retention systems can be roughly divided into bar-retained IODs in which multiple implants are splinted and the overdenture is attached through retentive clips and into retention systems using non-splinted solitary attachments Bar-retained IODs provide good retention require little maintenance but are more expensive than solitary attachments Medium term results of bar-retained IODs are promising with high implant and overdenture survival and low incidence of complications and may be considered the gold standard Solitary attachments serve as an alternative to bars These attachments are more economical and are easy to clean by the patient but wear more easily which can cause lack of retention However replacement of these attachments can often be done chair side A recent review reported that when a maxillary IOD is supported by four implants both types show equal implant survival overdenture survival and patient satisfaction However these conclusions are based on a limited amount of randomized controlled trials Moreover most studies reporting on solitary attachments were retrospective Evidence on maxillary IOD attachment systems has been mostly short to medium term non-comparing or retrospective and therefore inconclusive This underlines the need for studies comparing different attachment systems with a longer follow-up
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None