Clinical Evaluation of the Mandibular Mini-Implant Overdenture

Solventum US LLC80 enrolled

Overview

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.

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

Conditions

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

Interventions

Imtec MDIDEVICE

4 Imtec MDI

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (1)

Faculty of Dentistry, McGill University

Montreal, Quebec, Canada

Outcomes

Primary Outcomes

Success rate of mandibular overdentures supported by 4 MDIs placed in the interforaminal region in the long term.

Time frame: 3 years

Secondary Outcomes

Oral health-related quality of life and general satisfaction of patients.

Time frame: 3 years

Data from ClinicalTrials.gov

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