Clinical Evaluation of the Mandibular Mini-Implant Overdenture

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01064843

Enrollment

Registered

2010-02-09

Start date

2010-02-28

Completion date

2014-03-31

Last updated

2024-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Edentulous, Edentulism, Lower denture, Mini dental implant, Imtec MDI, Denture stabilization, Case success rate of overdentures stabilized by MDI, General satisfaction of patients with this treatment, Oral health-related quality of life of these patients, Cost estimates

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.

Interventions

DEVICEImtec MDI

4 Imtec MDI

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

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.

Design outcomes

Primary

Measure	Time frame
Success rate of mandibular overdentures supported by 4 MDIs placed in the interforaminal region in the long term.	3 years

Secondary

Measure	Time frame
Oral health-related quality of life and general satisfaction of patients.	3 years

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026