Clinical Evaluation of the Mandibular Mini-Implant Overdenture

3M Company

Status: Completed

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

Treatments: Device: Imtec MDI

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01064843

3M ESPE CR-09-020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

80 participants in 1 patient group

4 Imtec mini-dental implants (MDI)

Description:

4 Imtec MDI

Treatment:

Device: Imtec MDI