Piezosurgery Academy
Parma, 43100, Italy
NCT Number: NCT03357406
multi center study with randomized controlled trial design, split mouth
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Notify Me19 year and older
All sexes
Interventional
Not applicable
Parma, 43100, Italy
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
piezoelectric bone surgery will be used to create implant bone ostectomy
twist drills will be used to create implant bone ostectomy
Time frame: two years after surgery
how many implant are present in mouth
Time frame: two years after surgery
implant stable and fulfilling success criteria
Time frame: two years after surgery
every complication linked to the crown, implant abutment structure
Time frame: two years after surgery
radiographically assessed bone level
International Piezosurgery Academy
Other
Immediate Loading After Conventional and Ultrasonic Implant Site Preparation: a Multicenter Randomized Controlled Clinical Trial
Acronym: PI-DRI
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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