Stabilizing Mandibular Overdentures with a Single Implant Placed in the Canine Region of the Preferred Chewing Side Compared to the Midline Single-implant Overdenture Treatment Concept: an RCT with 5 Years of Follow-up

Frauke Müller1 site in 1 country36 target enrollmentJanuary 1, 2025

ConditionsCompletely Edentulous Patients

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Completely Edentulous Patients
Sponsor: Frauke Müller
Enrollment: 36
Locations: 1
Primary Endpoint: OHIP-EDENT
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The investigators are evaluating the use of a single implant to stabilize complete dentures in the lower jaw, in the canine region of the preferred chewing side. They are conducting this study to determine whether this treatment concept gives satisfactory results, and how it compares with the standard position in the center of the lower jaw.

Registry

clinicaltrials.gov

Start Date

January 1, 2025

End Date

December 2031

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Frauke Müller

Responsible Party

Sponsor Investigator

Principal Investigator

Frauke Müller

Professor, Head of Division

University of Geneva, Switzerland

Eligibility Criteria

Inclusion Criteria

•Informed consent signed by the subject
•Age ≥ 60 years
•Edentulous and wearing sufficient complete maxillary and mandibular dentures or ones that can be rendered sufficient via a reline and/or renewal of the prosthetic teeth
•Healed edentulous mandible (minimum 6-8 weeks since last extraction in the anterior zone (4-4) and one year in the posterior zone (5-8))
•Physical status ASA1 and ASA2

Exclusion Criteria

•Contraindications to the medical devices used, e.g. known hypersensitivity or allergy
•Vulnerable subjects
•Enrollment of the investigator, his/her family members, employees and other dependent persons
•Known or suspected non-compliance, drug or alcohol abuse
•Inability to perform adequate oral hygiene
•Inability to follow the procedures of the investigation, e.g. due to language problems, psychological disorders, dementia, Parkinson etc. of the subject (Dementia: clock-drawing test score ≤ 5)
•Surgical risk factors such as, but not limited to, uncontrolled diabetes, immunosuppression, radiation, chemotherapy, or antiresorptive medication (ex. Bisphosphonates)
•Heavy smoking habit: \>20 cig/d
•Reported severe bruxism or clenching habits, clinically present oro-facial pain
•Depression: Geriatric Depression Scale \> 9