Clinical Evaluation of the Mandibular Mini-Implant Overdenture

This study has been completed.
Sponsor:
Collaborator:
McGill University
Information provided by (Responsible Party):
3M
ClinicalTrials.gov Identifier:
NCT01064843
First received: February 5, 2010
Last updated: May 29, 2014
Last verified: May 2014
  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: Observational
Study Design: Time Perspective: Prospective
Official Title: Clinical Evaluation of the Mandibular Mini-Implant Overdenture

Resource links provided by NLM:


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 ]

Enrollment: 80
Study Start Date: February 2010
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
Sampling Method:   Non-Probability Sample
Study Population

Dental implant

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
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: NCT01064843

Locations
Canada, Quebec
Faculty of Dentistry, McGill University
Montreal, Quebec, Canada, H3A 2A7
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: May 29, 2014
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 July 24, 2014