Recruiting

Mandibular Overdentures

Sponsor:

University of Manitoba

Code:

NCT01566227

Conditions

Complete Edentulism

Eligibility Criteria

Sex: All

Age: 25+

Healthy Volunteers: Not accepted

Interventions

Questionnaire

Study Details

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.

Conditions

Complete Edentulism

Study ID

NCT01566227

Start date

Feb, 2012

Status verified date

Mar, 2012

Completion date

Apr, 2016

Anticipated

Primary completion date

Dec, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25+

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: number of implants

number of implants (1,2 or 3) used to retained an overdenture

Interventions

Questionnaire

3 surveys with 10 questions each: one before, during and after treatment

Primary outcome measure

  • Patient Satisfaction survey (questionnaires) [ Time Frame: every 6 months up to three years ]

Central Contacts and Locations

Central contacts

Reynaldo Todescan, Dr

204-7893782Reynaldo_Todescan@umanitoba.ca

Igor Pesun, Dr.

204-7893516pesun@cc.umanitoba.ca

Locations

University of Manitoba, Faculty of Dentistry

Recruiting

Winnipeg, Manitoba, Canada, R3E 0W2

Contacts

Reynaldo Todescan, DDS

204-7893782Reynaldo_Todescan@umanitoba.ca

Igor Pesun, DDS

204-7893516pesun@cc.umanitoba.ca

More Information

Sponsor

University of Manitoba

Last update posted

Mar 29, 2012

Last verified

Mar, 2012

Keywords

  • overdenture
  • implant
  • edentulism

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Manitoba on 2012-03-29.