Within-subject Comparison of Mandibular Overdentures Retained by 1,2,or 3 Implants
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2012
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 20, 2012
CompletedFirst Posted
Study publicly available on registry
March 29, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedMarch 29, 2012
March 1, 2012
3.8 years
February 20, 2012
March 26, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Patient Satisfaction survey (questionnaires)
Assess efficacy of treatment by analysis of patient's answer to a satisfaction survey.
every 6 months up to three years
Secondary Outcomes (2)
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 Arms (1)
number of implants
EXPERIMENTALnumber of implants (1,2 or 3) used to retained an overdenture
Interventions
3 surveys with 10 questions each: one before, during and after treatment
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Manitoba, Faculty of Dentistry
Winnipeg, Manitoba, R3E 0W2, Canada
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Department Head, Restorative Dentistry Department
Study Record Dates
First Submitted
February 20, 2012
First Posted
March 29, 2012
Study Start
February 1, 2012
Primary Completion
December 1, 2015
Study Completion
April 1, 2016
Last Updated
March 29, 2012
Record last verified: 2012-03