Within-subject Comparison of Mandibular Overdentures Retained by 1,2,or 3 Implants
- Conditions
- Complete Edentulism
- Interventions
- Other: Questionnaire
- Registration Number
- NCT01566227
- Lead Sponsor
- University of Manitoba
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
- 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.
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description number of implants Questionnaire number of implants (1,2 or 3) used to retained an overdenture
- Primary Outcome Measures
Name Time Method Patient Satisfaction survey (questionnaires) every 6 months up to three years Assess efficacy of treatment by analysis of patient's answer to a satisfaction survey.
- Secondary Outcome Measures
Name Time Method Radiographs every 6 months up to three years Assess crestal bone level around the implants.
Wear of 1 vs 2 vs 3 GPS retention components on complete dentures. baseline and 6 months The force required to remove the female retentive componenets from the male component will be compaired between one vs two vs three retentive components.
Trial Locations
- Locations (1)
University of Manitoba, Faculty of Dentistry
🇨🇦Winnipeg, Manitoba, Canada