Status:
UNKNOWN
Partially-guided Protocol for Maxillary Overdentures Retained by Ti-Zr One-piece Mini Implants
Lead Sponsor:
Universidade Federal de Goias
Collaborating Sponsors:
ITI International Team for Implantology, Switzerland
Institut Straumann AG
Conditions:
Edentulous Jaw
Implant Complication
Eligibility:
All Genders
60+ years
Phase:
NA
Brief Summary
This is a single-center, single-group, prospective clinical trial testing a partially-guided protocol for placement of mini implants overdentures in the edentulous maxilla. Eligible participants will ...
Detailed Description
Design This is a single-center, single-group, prospective clinical trial testing a partially-guided protocol for placement of mini implants overdentures in the edentulous maxilla. Study setting, tria...
Eligibility Criteria
Inclusion
- ≥ 60 years of age
- healed dentulous maxillary arch (minimum of twelve weeks since the last extraction)
- wearing a complete maxillary denture evaluated as sufficient for surgical planning
- minimal ridge dimensions of 5.4 mm (width) by 12 mm (height) in the anterior and premolar maxillary area
- bone dimensions allowing the placement of one-piece implants with a 2.4 mm-diameter and minimum length of 10 mm.
- general health condition should be a physical status ASA1 or ASA2.
Exclusion
- inability to perform adequate oral hygiene
- incapability to provide written informed consent and compliance to the protocol
- any contraindication for oral surgery such as but not limited to,
- uncontrolled diabetes
- immunosuppression
- radiation or chemotherapy
- antiresorptive medication such as bisphosphonates
- presence of dental, periodontal or peri-implant disease in the opposing arch
- presence of a conventional complete denture in the opposing arch (mandible)
- presence of an insufficient partial removable denture or implant-overdenture in the opposing arch, which cannot be rendered sufficient by a reline
- heavy smoking habit with \> 20 cig/d
- reported severe bruxism or clenching habits
- clinically present oro-facial pain
- depression with a Geriatric Depression Scale above 12
- xerostomia with a stimulated salivary flow rate inferior to 0.7 ml/min
- ridge morphology type IV (Cawood and Howell, 1988)
- defects requiring bone augmentation procedures, or unhealthy soft tissues.
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06081192
Start Date
January 1 2024
End Date
December 1 2025
Last Update
October 13 2023
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