Clinical Evaluation of the Mandibular Mini-Implant Overdenture

Solventum US LLC1 site in 1 country80 target enrollmentFebruary 2010

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

Overview

Phase: N/A
Intervention: Not specified
Conditions: Stabilization of a Full Lower Denture
Sponsor: Solventum US LLC
Enrollment: 80
Locations: 1
Primary Endpoint: Success rate of mandibular overdentures supported by 4 MDIs placed in the interforaminal region in the long term.
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

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.

Registry

clinicaltrials.gov

Start Date

February 2010

End Date

March 2014

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Solventum US LLC

Responsible Party

Sponsor

Eligibility Criteria

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.