Stabilizing Mandibular Overdentures With a Single Implant Placed in the Canine Region of the Preferred Chewing Side
NCT ID: NCT06755034
Last Updated: 2025-03-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
36 participants
INTERVENTIONAL
2025-01-01
2031-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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c-SIMO
Placement of an implant in the mandibular canine area and using it to stabilize a pre-existing mandibular complete denture.
c-SIMO
Placement of an implant in the mandibular canine area and using it to stabilize a pre-existing mandibular complete denture.
m-SIMO
Placement of an implant in the midline of the mandible and using it to stabilize a pre-existing mandibular complete denture.
m-SIMO
Placement of an implant in the midline of the mandible and using it to stabilize a pre-existing mandibular complete denture.
Interventions
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c-SIMO
Placement of an implant in the mandibular canine area and using it to stabilize a pre-existing mandibular complete denture.
m-SIMO
Placement of an implant in the midline of the mandible and using it to stabilize a pre-existing mandibular complete denture.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
60 Years
ALL
No
Sponsors
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Frauke Müller
OTHER
Responsible Party
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Frauke Müller
Professor, Head of Division
Principal Investigators
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Sabrina Maniewicz
Role: PRINCIPAL_INVESTIGATOR
University of Geneva
Frauke Müller
Role: STUDY_DIRECTOR
University of Geneva
Locations
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University Clinics of Dental Medicine, University of Geneva
Geneva, Canton of Geneva, Switzerland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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DGPA_2024_02
Identifier Type: -
Identifier Source: org_study_id
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