Within-subject Comparison of Mandibular Overdentures Retained by 1,2,or 3 Implants
This study is currently recruiting participants.
Verified March 2012 by University of Manitoba
Sponsor:
University of Manitoba
Information provided by (Responsible Party):
IPesun (1), University of Manitoba
ClinicalTrials.gov Identifier:
NCT01566227
First received: February 20, 2012
Last updated: March 26, 2012
Last verified: March 2012
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Purpose
This research is being done to find out the ideal number of implants/attachments required to provide adequate stability of dentures during function.
| Condition | Intervention |
|---|---|
|
Complete Edentulism |
Other: Questionnaire |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Within-subject Comparison of Mandibular Overdentures Retained by 1,2,or 3 Implants |
Resource links provided by NLM:
Further study details as provided by University of Manitoba:
Primary Outcome Measures:
- Patient Satisfaction survey (questionnaires) [ Time Frame: every 6 months up to three years ] [ Designated as safety issue: No ]Assess efficacy of treatment by analysis of patient's answer to a satisfaction survey.
Secondary Outcome Measures:
- Radiographs [ Time Frame: every 6 months up to three years ] [ Designated as safety issue: No ]Assess crestal bone level around the implants.
- Wear of 1 vs 2 vs 3 GPS retention components on complete dentures. [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]The force required to remove the female retentive componenets from the male component will be compaired between one vs two vs three retentive components.
| Estimated Enrollment: | 30 |
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | April 2016 |
| Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: number of implants
number of implants (1,2 or 3) used to retained an overdenture
|
Other: Questionnaire
3 surveys with 10 questions each: one before, during and after treatment
Other Names:
|
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.
Eligibility| Ages Eligible for Study: | 25 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01566227
Contacts
| Contact: Reynaldo Todescan, Dr | 204-7893782 | Reynaldo_Todescan@umanitoba.ca |
| Contact: Igor Pesun, Dr. | 204-7893516 | pesun@cc.umanitoba.ca |
Locations
| Canada, Manitoba | |
| University of Manitoba, Faculty of Dentistry | Recruiting |
| Winnipeg, Manitoba, Canada, R3E 0W2 | |
| Contact: Reynaldo Todescan, DDS 204-7893782 Reynaldo_Todescan@umanitoba.ca | |
| Contact: Igor Pesun, DDS 204-7893516 pesun@cc.umanitoba.ca | |
| Sub-Investigator: Reynaldo Todescan, DDS | |
Sponsors and Collaborators
University of Manitoba
Investigators
| Principal Investigator: | Igor Pesun, DDS | Univ. of Manitoba, Faculty of Dentistry |
| Study Director: | Reynaldo Todescan, DDS. | Univ of Manitoba, Faculty of Dentistry |
| Study Chair: | Mike Barczac, DDS | Univ of Manitoba, Faculty of Dentistry |
More Information
No publications provided
| Responsible Party: | IPesun (1), Department Head, Restorative Dentistry Department, University of Manitoba |
| ClinicalTrials.gov Identifier: | NCT01566227 History of Changes |
| Other Study ID Numbers: | B2012:012 |
| Study First Received: | February 20, 2012 |
| Last Updated: | March 26, 2012 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by University of Manitoba:
|
overdenture implant edentulism |
ClinicalTrials.gov processed this record on May 16, 2013