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Clinical Evaluation of the Mandibular Mini-Implant Overdenture

This study is currently recruiting participants.
Verified January 2013 by 3M
Sponsor:
Collaborator:
McGill University
Information provided by (Responsible Party):
3M
ClinicalTrials.gov Identifier:
NCT01064843
First received: February 5, 2010
Last updated: January 28, 2013
Last verified: January 2013
History of Changes
  Purpose

Stabilization of existing full lower dentures by means of mini-dental implants (MDI). To test whether 4 mini-implants placed at the front of the lower jaw can stabilize an immediately-modified existing lower denture.


Condition Intervention
Stabilization of a Full Lower Denture
Edentulism in Lower Jaw
Lower Denture Made Within Last Few Years
 Device: Imtec MDI

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Evaluation of the Mandibular Mini-Implant Overdenture

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by 3M:

Primary Outcome Measures:
  • Success rate of mandibular overdentures supported by 4 MDIs placed in the interforaminal region in the long term. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Oral health-related quality of life and general satisfaction of patients. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: February 2010
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 4 Imtec mini-dental implants (MDI)
4 Imtec MDI
 Device: Imtec MDI
4 Imtec MDI

Detailed Description:

To test whether the percentage of case successes of these lower dentures supported by 4 MDIs is equal to or greater than 95% at 1 year. Success is defined as a denture supported by implants that is functioning in the way it was intended.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Completely edentulous with last tooth extraction 2 years ago or longer.
  • Patients requesting implant stabilization of existing lower conventional denture.
  • Adequate space in anterior mandible for placement of 4 MDI implants.
  • Able to maintain adequate oral hygiene and keep dentures clean.
  • Healthy enough to have minor surgical procedures.
  • Have adequate understanding of written and spoken English or French.
  • Capable of providing written informed consent.

Exclusion Criteria:

  • Not enough room in mandibular bone for implant height.
  • Has acute or chronic symptoms of parafunctional disorders.
  • History of radiotherapy to orofacial region.
  • Are or have been taking bisphosphonate IV or other medications (to be evaluated by the researcher).
  • Health conditions that may jeopardize treatment (to be evaluated by the researcher).
  • Unable or unwilling to return for evaluations or study recalls.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01064843

Contacts
Contact: Alan Moskovic, BSC, GDM 514-398-7203 ext 09056 alan.moskovic@mcgill.ca

Locations
Canada, Quebec
Faculty of Dentistry, McGill University Recruiting
Montreal, Quebec, Canada, H3A 2A7
Contact: Alan Moskovic, BSC, GDM     514-398-7203 ext 09056     alan.moskovic@mcgill.ca    
Principal Investigator: Jocelyne Feine, DDS, MSc, HDR            
Sponsors and Collaborators
3M
McGill University
Investigators
Principal Investigator: Jocelyne Feine, DDS, MSc, HDR Professor, Principal Investigator
  More Information

No publications provided

Responsible Party: 3M
ClinicalTrials.gov Identifier: NCT01064843     History of Changes
Other Study ID Numbers: 3M ESPE CR-09-020
Study First Received: February 5, 2010
Last Updated: January 28, 2013
Health Authority: Canada: Health Canada

Keywords provided by 3M:
Edentulous
Edentulism
Lower denture
Mini dental implant
Imtec MDI
 Denture stabilization
Case success rate of overdentures stabilized by MDI
General satisfaction of patients with this treatment
Oral health-related quality of life of these patients
Cost estimates

ClinicalTrials.gov processed this record on May 21, 2013