Within-subject Comparison of Mandibular Overdentures Retained by 1,2,or 3 Implants
This research is being done to find out the ideal number of implants/attachments required to provide adequate stability of dentures during function.
|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|
- 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.
- 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.
|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)|
Experimental: number of implants
number of implants (1,2 or 3) used to retained an overdenture
3 surveys with 10 questions each: one before, during and after treatment
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01566227
|Contact: Reynaldo Todescan, Dr||204-7893782||Reynaldo_Todescan@umanitoba.ca|
|Contact: Igor Pesun, Dr.||firstname.lastname@example.org|
|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 email@example.com|
|Sub-Investigator: Reynaldo Todescan, DDS|
|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|