Clinical Evaluation of the Mandibular Mini-Implant Overdenture

3

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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