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

March 26, 2012 updated by: IPesun (1), University of Manitoba
This research is being done to find out the ideal number of implants/attachments required to provide adequate stability of dentures during function.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0W2
        • Recruiting
        • University of Manitoba, Faculty of Dentistry
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Reynaldo Todescan, DDS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
every 6 months up to three years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographs
Time Frame: every 6 months up to three years
Assess crestal bone level around the implants.
every 6 months up to three years
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.
baseline and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

April 1, 2016

Study Registration Dates

First Submitted

February 20, 2012

First Submitted That Met QC Criteria

March 26, 2012

First Posted (Estimate)

March 29, 2012

Study Record Updates

Last Update Posted (Estimate)

March 29, 2012

Last Update Submitted That Met QC Criteria

March 26, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • B2012:012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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