Clinical Evaluation of the Mandibular Mini-Implant Overdenture

Completed

• Conditions: Edentulism in Lower Jaw; Lower Denture Made Within Last Few Years; Stabilization of a Full Lower Denture
• Interventions: Device: Imtec MDI

• Registration Number: NCT01064843
• Lead Sponsor: Solventum US LLC

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.

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-02-05
• Study First Submitted QC: 2010-02-08
• Study First Posted: 2010-02-09
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-27
• Last Update Posted: 2024-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
4 Imtec mini-dental implants (MDI)	Imtec MDI	4 Imtec MDI

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Oral health-related quality of life and general satisfaction of patients.	3 years

Trial Locations

Locations (1)

Faculty of Dentistry, McGill University; 🇨🇦 Montreal, Quebec, Canada