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Clinical Evaluation of the Mandibular Mini-Implant Overdenture

This study has been completed.
McGill University
Information provided by (Responsible Party):
3M Identifier:
First received: February 5, 2010
Last updated: May 29, 2014
Last verified: May 2014
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 ]

Secondary Outcome Measures:
  • Oral health-related quality of life and general satisfaction of patients. [ Time Frame: 3 years ]

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.

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Dental implant

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
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Please refer to this study by its identifier: NCT01064843

Canada, Quebec
Faculty of Dentistry, McGill University
Montreal, Quebec, Canada, H3A 2A7
Sponsors and Collaborators
McGill University
Principal Investigator: Jocelyne Feine, DDS, MSc, HDR Professor, Principal Investigator
  More Information

Responsible Party: 3M 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

Keywords provided by 3M:
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 processed this record on September 21, 2017