Stabilizing Mandibular Overdentures With a Single Implant Placed in the Canine Region of the Preferred Chewing Side

Recruiting now · Not applicable

Conditions studied: Completely Edentulous Patients

In brief

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.

Key facts

Study ID

NCT06755034

Run by

Frauke Müller

People needed

36

Starts

2025-01-01

Expected to finish

2031-12-01

Last updated by the study team

2025-03-26

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Xerostomia: SSFR ≤ 0.7ml/min
• Ridge dimensions <6 mm (width) by 10 mm (height) in the canine or midline area
• Ridge defects requiring bone augmentation procedures

Where it is running

• University Clinics of Dental Medicine, University of Geneva — Geneva, Canton of Geneva, Switzerland (enrolling)

Full record on ClinicalTrials.gov

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