Clinical Evaluation of the Mandibular Mini-Implant Overdenture

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.

Study Overview

• Status: Completed
• Conditions: Stabilization of a Full Lower Denture; Edentulism in Lower Jaw; Lower Denture Made Within Last Few Years
• Intervention / Treatment: Device: 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.

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3A 2A7
      • Faculty of Dentistry, McGill University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Dental implant

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
4 Imtec mini-dental implants (MDI); 4 Imtec MDI	Device: Imtec MDI; 4 Imtec MDI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Success rate of mandibular overdentures supported by 4 MDIs placed in the interforaminal region in the long term.	3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Oral health-related quality of life and general satisfaction of patients.	3 years

Collaborators and Investigators

• Sponsor: 3M
• Collaborators: McGill University
• Investigators: Principal Investigator: Jocelyne Feine, DDS, MSc, HDR, Professor, Principal Investigator

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (ACTUAL): March 1, 2014
• Study Completion (ACTUAL): March 1, 2014

Study Registration Dates

• First Submitted: February 5, 2010
• First Submitted That Met QC Criteria: February 8, 2010
• First Posted (ESTIMATE): February 9, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): May 30, 2014
• Last Update Submitted That Met QC Criteria: May 29, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: Edentulous; Cost estimates; 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
• Other Study ID Numbers: 3M ESPE CR-09-020