Conventional and Ultrasonic Implant Site Preparation (PI-DRI)

International Piezosurgery Academy

Status

Completed

Conditions

Bone Atrophy, Alveolar

Treatments

Procedure: conventional implant site preparation

Procedure: ultrasound implant site preparation

Study type

Interventional

Funder types

Other

Identifiers

NCT03357406

piezo-drills

Details and patient eligibility

About

multi center study with randomized controlled trial design, split mouth

Full 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 different surgical protocols. Each patient will receive two identical implants: after randomization, the test site will be prepared by ultrasonic microvibrations and the control site using twist drills. Both implants will be loaded with a provisional crown within 48 hours after surgery. For each inserted implant, collection of experimental parameters will be required up to 2 years after surgery.

Enrollment

75 patients

Sex

All

Ages

19+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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 criteria

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%)