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

Launched by FRAUKE MÜLLER · Dec 23, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new way to help stabilize lower dentures for people who have lost all their teeth. Specifically, researchers are looking at placing a single dental implant in the canine area on the side of the jaw where patients prefer to chew. The goal is to see if this method works well and how it compares to the traditional approach of placing the implant in the center of the lower jaw.

To participate in the study, individuals must be at least 60 years old, have no teeth (completely edentulous), and currently wear dentures that fit properly or can be adjusted. It's important that the jaw has healed properly since any extractions, and participants should be in good overall health. During the trial, participants will receive care related to the dental implant and will be monitored to assess the effectiveness of this new approach. If you're considering joining, it's a chance to help improve denture stability for yourself and others in the future!

Gender

ALL

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
• • 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