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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01566227
Recruitment Status : Unknown
Verified March 2012 by IPesun (1), University of Manitoba.
Recruitment status was:  Recruiting
First Posted : March 29, 2012
Last Update Posted : March 29, 2012
Information provided by (Responsible Party):
IPesun (1), 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.

Condition or disease Intervention/treatment
Complete Edentulism Other: Questionnaire

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Within-subject Comparison of Mandibular Overdentures Retained by 1,2,or 3 Implants
Study Start Date : February 2012
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : April 2016

Arm Intervention/treatment
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:
  • Satisfaction survey
  • questionnaire for patient satisfaction

Primary Outcome Measures :
  1. Patient Satisfaction survey (questionnaires) [ Time Frame: every 6 months up to three years ]
    Assess efficacy of treatment by analysis of patient's answer to a satisfaction survey.

Secondary Outcome Measures :
  1. Radiographs [ Time Frame: every 6 months up to three years ]
    Assess crestal bone level around the implants.

  2. Wear of 1 vs 2 vs 3 GPS retention components on complete dentures. [ Time Frame: 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.

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Ages Eligible for Study:   25 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01566227

Contact: Reynaldo Todescan, Dr 204-7893782
Contact: Igor Pesun, Dr. 204-7893516

Canada, Manitoba
University of Manitoba, Faculty of Dentistry Recruiting
Winnipeg, Manitoba, Canada, R3E 0W2
Contact: Reynaldo Todescan, DDS    204-7893782   
Contact: Igor Pesun, DDS    204-7893516   
Sub-Investigator: Reynaldo Todescan, DDS         
Sponsors and Collaborators
University of Manitoba
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

Responsible Party: IPesun (1), Department Head, Restorative Dentistry Department, University of Manitoba Identifier: NCT01566227     History of Changes
Other Study ID Numbers: B2012:012
First Posted: March 29, 2012    Key Record Dates
Last Update Posted: March 29, 2012
Last Verified: March 2012

Keywords provided by IPesun (1), University of Manitoba: