Using a single implant to stabilize lower dentures in older adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of placing a single implant in the canine region of the preferred chewing side to stabilize complete dentures for completely edentulous patients. The goal is to determine if this approach yields satisfactory results compared to the traditional implant placement in the center of the lower jaw. Participants will be older adults who are edentulous and currently using or can use complete dentures. The study will assess the stability and comfort of the dentures with the new implant placement method.

Why it matters

Who can join: the full rules

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

Where it's running

• University Clinics of Dental Medicine, University of Geneva
  Geneva, Canton of Geneva, Switzerland Recruiting

Study contacts

• Principal investigator: Sabrina Maniewicz — University of Geneva, Switzerland
• Study coordinator: Sabrina Maniewicz
• Email: sabrina.maniewicz@unige.ch
• Phone: +4122 379 40 60

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.