Within-subject Comparison of Mandibular Overdentures Retained by 1,2,or 3 Implants
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- University of Manitoba
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Patient Satisfaction survey (questionnaires)
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 25 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
number of implants
number of implants (1,2 or 3) used to retained an overdenture
Intervention: Questionnaire (Other)
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)
Investigators
IPesun (1)
Department Head, Restorative Dentistry Department
University of Manitoba