Clinical trial NCT06755034: Stabilizing Mandibular Overdentures With a Single Implant Placed in the Canine Region of the Preferred Chewing Side
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Completely Edentulous Patients
Lead sponsor: University of Geneva, Switzerland
Sponsor class: OTHER
First posted: 2025-01-01
Enrollment: 36
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: OHIP-EDENT
timeFrame: From baseline to 5-year follow-up
measure: DSI
timeFrame: From baseline to 5-year follow-up
Secondary outcomes:
measure: Preferred chewing side
timeFrame: From baseline to 5-year follow-up
measure: Chewing efficiency
timeFrame: From baseline to 5-year follow-up
measure: Occlusal analysis
timeFrame: From baseline to 5-year follow-up
measure: Plaque index
timeFrame: From implant loading to 5-year follow-up
measure: Bleeding on probing
timeFrame: From implant loading to 5-year follow-up
measure: Pocket probing depth
timeFrame: From implant loading to 5-year follow-up
measure: Keratinized peri-implant tissues
timeFrame: From implant loading to 5-year follow-up
measure: Prosthodontic assessment
timeFrame: From implant loading to 5-year follow-up
measure: Peri-implant bone height
timeFrame: From implant loading to 5-year follow-up
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: University Clinics of Dental Medicine, University of Geneva
Study officials:
affiliation: University of Geneva
name: Sabrina Maniewicz
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Geneva
name: Frauke Müller
role: STUDY_DIRECTOR
References: