Status:
ACTIVE_NOT_RECRUITING
Titanium Zirconium (TiZr) Mini Implants
Lead Sponsor:
University of Bern
Conditions:
Dental Implants
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
H0: "Within the first year post-placement, four interforaminally placed, immediately loaded 2.4 mm narrow-diameter one-piece TiZr implants with miniaturized stud-type attachments show improved patient...
Eligibility Criteria
Inclusion
- At patient level:
- Written informed consent
- Age ≥ 18 years
- Sufficient complete dentures (Marxkors and Ferger, 1989) not older than 1 year
- Patient is unsatisfied with mandibular denture to the degree that he/she seeks treatment
- At site level:
- Healed edentulous mandible (minimum 8 weeks since last extraction)
- Minimal ridge dimensions 5.5 mm (width) by 12 mm (height) in the anterior (interforaminal) area, allowing the placement of 3.3 (endosseous diameter) by 10 mm (length) implants
- Opposing dentition: complete denture on a edentulous maxilla
- Physical status (PS) 1 and 2 (American Society of Anesthesiologists)
Exclusion
- At patient level
- Any physical or mental disorder that would interfere with the ability to perform adequate oral hygiene or the capability of providing written informed consent and compliance to the protocol
- Any disorder that would interfere with wound healing or represent a contraindication for oral surgery such as, but not limited to, uncontrolled diabetes or conditions resulting in or requiring immunosuppression, radiation, chemotherapy, frequent use of antibiotics or antiresorptive medication such as bisphosphonates
- Pregnancy or lactation
- Heavy smoking habit with \> 20 cig/d
- Severe bruxism or clenching habits, present oro-facial pain
- At site level:
- Ridge defects requiring staged bone augmentation procedures (simultaneous Guided Bone Regeneration (GBR) within the ridge contour allowed)
Key Trial Info
Start Date :
September 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2033
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT03837158
Start Date
September 1 2019
End Date
August 1 2033
Last Update
November 6 2024
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Private Practice Dr. B. Wallkamm
Langenthal, Canton of Bern, Switzerland, 4900
2
University of Bern
Bern, Switzerland, 3010