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Clinical Trials/NCT01566227
NCT01566227
Unknown
N/A

Within-subject Comparison of Mandibular Overdentures Retained by 1,2,or 3 Implants

University of Manitoba1 site in 1 country30 target enrollmentFebruary 2012

Overview

Phase
N/A
Intervention
Not specified
Conditions
Complete Edentulism
Sponsor
University of Manitoba
Enrollment
30
Locations
1
Primary Endpoint
Patient Satisfaction survey (questionnaires)
Last Updated
14 years ago

Overview

Brief Summary

This research is being done to find out the ideal number of implants/attachments required to provide adequate stability of dentures during function.

Detailed Description

The aim of this study is threefold: i) to evaluate within-subject response to complete lower dentures retained by 1 or 2 or 3 implants fitted with independent overdenture attachments; ii) laboratory evaluation of the retention force generated with 1-2 or 3-implants and study its correlation to patients' response; iii) study the wear pattern of the plastic inserts on the overdenture abutments during each retention mode (i.e. the number of implants used to retain the dentures) and correlate its effects to denture stability.

Registry
clinicaltrials.gov
Start Date
February 2012
End Date
April 2016
Last Updated
14 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

IPesun (1)

Department Head, Restorative Dentistry Department

University of Manitoba

Eligibility Criteria

Inclusion Criteria

  • subjects completely edentulous on maxilla and mandible for at least a year (w/out dentures)
  • Adult age (25 plus) male or female
  • Stable medical health
  • Ability to participate in the study for at least 3-4 years
  • Able to understand and respond to surveys used in the study
  • Adequate amount of bone in the mandible to receive 3 implants.

Exclusion Criteria

  • history of drug and alcohol abuse, excessive smoking (more than 1 pack/day)
  • surgical limitations:
  • uncontrolled systemic disease: diabetes, etc.. that may compromised healing
  • irradiated surgical site
  • inadequate bone height and width (re: implant size)
  • inability to undergo minor oral surgery because of health or personal reasons
  • psychological and handicapped conditions that may hinder 4-year involvement (physical handicap conditions)
  • Severe TMDs related to joint pathology

Outcomes

Primary Outcomes

Patient Satisfaction survey (questionnaires)

Time Frame: every 6 months up to three years

Assess efficacy of treatment by analysis of patient's answer to a satisfaction survey.

Secondary Outcomes

  • Radiographs(every 6 months up to three years)
  • Wear of 1 vs 2 vs 3 GPS retention components on complete dentures.(baseline and 6 months)

Study Sites (1)

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