Using a single implant to stabilize lower dentures in older adults

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

This study is testing if putting one implant in the side of the jaw can help older adults with complete dentures feel more stable and comfortable compared to the usual method of placing the implant in the center.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 60 Years and up
• Sex: All
• Sponsor: University of Geneva, Switzerland (other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Geneva, Canton of Geneva)
• Trial ID: NCT06755034 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 60 and older who are completely edentulous and can wear or modify their dentures.

Not a fit: Patients with contraindications to the medical devices used or those unable to maintain adequate oral hygiene may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve the stability and comfort of dentures for older adults, enhancing their quality of life.

How similar studies have performed: Previous studies have shown promising results with similar implant stabilization techniques, indicating potential for success in this approach.

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

Where this trial is running

Geneva, Canton of Geneva

• 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

Conditions: Completely Edentulous Patients