Status:
UNKNOWN
A Triple-blinded Non-inferiority Multicentre Randomized Controlled Trial Comparing Hybrid and Fully Etched Implants P1
Lead Sponsor:
University of Milan
Conditions:
Dental Implants
Eligibility:
All Genders
20+ years
Phase:
NA
Brief Summary
The goal of this randomized controlled clinical trial is to compare implant stability between hybrid implants and fully rough implants in partially edentulous patients. The main question it aims to an...
Detailed Description
This is a randomized triple-blinded, parallel-arm (1:1) controlled clinical trial with 6 months follow-up. Implants will be placed in 16 private practices. 128 patients will be randomly allocated to t...
Eligibility Criteria
Inclusion
- Partially edentulous patients who need at least one fixed partial denture supported by 1 or 2 implants;
- Men and women over 20 years old;
- Periodontally stable patients
- Sufficient 3D bone availability
- Ideal 3D implant placement: MD: minimum tooth-implant distance of 1.5 mm and minimum inter-implant distance of 3 mm; at least 1.5 mm of buccal plate thickness; the implants should be placed equicrestally or 1 mm subcrestally in such a way that the machined part remains completely submerged; the distance between the implant neck and the adjacent dentition should be less than 6mm; straight implants (0 to 20 degrees from the adjacent tooth long axis or 70 to 90 degrees from the ridge parallelism);
Exclusion
- Pregnant or lactating women;
- Uncontrolled systemic conditions;
- Patients on drugs known to interfere with the bone metabolism;
- Current smokers;
- Simultaneous/staged regenerative procedures;
- Immediate loading;
- Immediate implants;
- Short implants (\< 8 mm) or narrow implant (diameter \<3.3 mm);
Key Trial Info
Start Date :
November 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2025
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT06100120
Start Date
November 15 2023
End Date
January 1 2025
Last Update
December 1 2023
Active Locations (1)
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1
Clinica Odontoiatrica IRCCS Ospedale Maggiore Policlinico
Milan, MI, Italy, 20122