Immediate Loading After Conventional and Ultrasonic Implant Site Preparation: a Multicenter Randomized Controlled Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- implant survival rate
Study Overview
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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Masking Description
treatment method is masked till the surgical procedure, during which, both surgeon and patient are informed
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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%)
Arms & Interventions
edentulism side 1
ultrasound implant site preparation
Intervention: ultrasound implant site preparation (Procedure)
edentulism side 2
conventional implant site preparation
Intervention: conventional implant site preparation (Procedure)
Outcomes
Primary Outcomes
implant survival rate
Time Frame: two years after surgery
how many implant are present in mouth
Secondary Outcomes
- implant success rate(two years after surgery)
- biomechanical complications(two years after surgery)
- marginal bone loss(two years after surgery)
Investigators
Mr. Claudio Stacchi, DDS, MSc
President of International Piezosurgery Academy
International Piezosurgery Academy