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
  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:
  • Satisfaction survey
  • questionnaire for patient satisfaction

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 21, 2014