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Within-subject Comparison of Mandibular Overdentures Retained by 1,2,or 3 Implants

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2012 by University of Manitoba
Sponsor:
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

February 20, 2012
March 26, 2012
February 2012
December 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01566227 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Within-subject Comparison of Mandibular Overdentures Retained by 1,2,or 3 Implants
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.

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Complete Edentulism
Other: Questionnaire
3 surveys with 10 questions each: one before, during and after treatment
Other Names:
  • Satisfaction survey
  • questionnaire for patient satisfaction
Experimental: number of implants
number of implants (1,2 or 3) used to retained an overdenture
Intervention: Other: Questionnaire
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
April 2016
December 2015   (final data collection date for primary outcome measure)

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
Both
25 Years and older
No
Contact: Reynaldo Todescan, Dr 204-7893782 Reynaldo_Todescan@umanitoba.ca
Contact: Igor Pesun, Dr. 204-7893516 pesun@cc.umanitoba.ca
Canada
 
NCT01566227
B2012:012
No
IPesun (1), University of Manitoba
University of Manitoba
Not Provided
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
University of Manitoba
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP