Status:
COMPLETED
Conventional and Ultrasonic Implant Site Preparation
Lead Sponsor:
International Piezosurgery Academy
Conditions:
Bone Atrophy, Alveolar
Eligibility:
All Genders
19+ years
Phase:
NA
Brief Summary
multi center study with randomized controlled trial design, split mouth
Detailed Description
The present study has been designed as a multicenter prospective randomized controlled trial design. Fifteen clinical centers will treat patients by inserting and immediately loading implants with two...
Eligibility Criteria
Inclusion
- indications for two implant-supported single crowns with immediate loading in the upper or lower arch (in the incisor, canine or premolar area), based on accurate diagnosis and treatment planning; 2) implants can be in the same or in different quadrants; 3) implant sites must be performed in similar bone quality (i.e. both maxillary or mandibular); 4) the bone crest must be healed (at least three months elapsed after tooth loss); 5) presence of a residual bone crest with an adequate volume to allow the insertion of a 3.8x11.5 mm implant without any kind of regenerative procedure; 6) age of the patient \>18 years; 7) patient willing and fully capable to comply with the study protocol; 8) written informed consent given;
Exclusion
- acute myocardial infarction within the past 2 months;
- uncontrolled coagulation disorders;
- uncontrolled diabetes (HBA1c \> 7.5%);
- radiotherapy to the head/neck district within the past 24 months;
- immunocompromised patient (HIV infection or chemotherapy within the past 5 years);
- present or past treatment with intravenous bisphosphonates;
- psychological or psychiatric problems;
- alcohol or drugs abuse Local exclusion criterion is the presence of uncontrolled or untreated periodontal disease (full mouth plaque score and full mouth bleeding score \> 25%)
Key Trial Info
Start Date :
February 15 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 15 2017
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT03357406
Start Date
February 15 2016
End Date
November 15 2017
Last Update
November 29 2017
Active Locations (1)
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1
Piezosurgery Academy
Parma, Italy, 43100