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Clinical Evaluation of the Mandibular Mini-Implant Overdenture

NCT ID: NCT01064843

Last Updated: 2024-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-02-28

Study Completion Date

2014-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Stabilization of a Full Lower Denture Edentulism in Lower Jaw Lower Denture Made Within Last Few Years

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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4 Imtec mini-dental implants (MDI)

4 Imtec MDI

Imtec MDI

Intervention Type DEVICE

4 Imtec MDI

Interventions

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Imtec MDI

4 Imtec MDI

Intervention Type DEVICE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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McGill University

OTHER

Sponsor Role collaborator

3M

INDUSTRY

Sponsor Role collaborator

Solventum US LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jocelyne Feine, DDS, MSc, HDR

Role: PRINCIPAL_INVESTIGATOR

Professor, Principal Investigator

Locations

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Faculty of Dentistry, McGill University

Montreal, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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3M ESPE CR-09-020

Identifier Type: -

Identifier Source: org_study_id