Bone Atrophy, Alveolar
Conditions
Keywords
implant, piezoelectric, drills, immediate loading
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.
Interventions
PROCEDUREultrasound implant site preparation
piezoelectric bone surgery will be used to create implant bone ostectomy
PROCEDUREconventional implant site preparation
twist drills will be used to create implant bone ostectomy
Sponsors
International Piezosurgery Academy
Study design
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
Intervention model description
Split mouth design
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
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
1. acute myocardial infarction within the past 2 months; 2. uncontrolled coagulation disorders; 3. uncontrolled diabetes (HBA1c \> 7.5%); 4. radiotherapy to the head/neck district within the past 24 months; 5. immunocompromised patient (HIV infection or chemotherapy within the past 5 years); 6. present or past treatment with intravenous bisphosphonates; 7. psychological or psychiatric problems; 8. 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%)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| implant survival rate | two years after surgery | how many implant are present in mouth |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| implant success rate | two years after surgery | implant stable and fulfilling success criteria |
| biomechanical complications | two years after surgery | every complication linked to the crown, implant abutment structure |
| marginal bone loss | two years after surgery | radiographically assessed bone level |
Countries
Italy
Outcome results
None listed