Status:
NOT_YET_RECRUITING
Clinical Study Investigating the Efficiency and Complications Related to Two Different Procedures Used for the Preparation of Dentures Applied in Patients With Edentulous
Lead Sponsor:
University of Zurich
Collaborating Sponsors:
ITI Foundation
Conditions:
Edentulous Maxilla
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The principal aim of the study is to evaluate the prosthetic complications with CAD-CAM fabricated provisional prostheses and denture conversion prostheses after 3 months of function. Supported restor...
Detailed Description
1. Study Intervention and Indication CAD-CAM fabricated provisional prostheses facilitate prosthesis delivery in immediate functional loading protocols. The prostheses are manufactured in the laborato...
Eligibility Criteria
Inclusion
- Patients should be of minimum 18 years to be included in the study.
- Patient with edentulous maxilla
- Presence of natural teeth or dentures in the mandibular arch
- Presence of adequate primary stability during implant placement.
- Adequate bone volume to place at least 4 implants with regular platform of at least 6 mm in length
- Presence of at least 6mm (height) of bone in the distal most prosthetic position (in the region of 2nd premolar or 1st molar)
- Presence of at least 8 mm (height) and 6 mm (width) of bone in the anterior region (canine or lateral incisor) to place an implant of a regular diameter and a minimum length of 8 mm.
- Presence of healed maxillary edentulous ridge (at least 3 months post extraction)
- Written informed consent
Exclusion
- Self reported history of bruxism
- Uncontrolled diabetes (HbA1c\>7.5 mg/dl)
- History of irradiation in the head and neck region
- Inability to comply with annual implant maintenance follow up
- Ridge profile not allowing the placement of a fixed prostheses.
- Presence of any uncontrolled systemic disease that contraindicates implant placement.
- Pregnant or lactating women
Key Trial Info
Start Date :
May 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2028
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05332977
Start Date
May 1 2022
End Date
October 1 2028
Last Update
April 18 2022
Active Locations (1)
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1
M.A. Rangoonwala College of Dental Sciences and Research Center, Department of Prosthodontics
Pune, India, 411001