Conventional and Ultrasonic Implant Site Preparation

Study Overview
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Brief Summary
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multi center study with randomized controlled trial design, split mouth

Detailed Description
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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.

Official Title
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Immediate Loading After Conventional and Ultrasonic Implant Site Preparation: a Multicenter Randomized Controlled Clinical Trial

Conditions
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Bone Atrophy, Alveolar

Intervention / Treatment
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* Procedure: ultrasound implant site preparation
* Procedure: conventional implant site preparation


Participation Criteria
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Eligibility Criteria
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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%)

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Split mouth design
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: edentulism side 1<br>ultrasound implant site preparation | Procedure: ultrasound implant site preparation<br>* piezoelectric bone surgery will be used to create implant bone ostectomy<br>|
| Active Comparator: edentulism side 2<br>conventional implant site preparation | Procedure: conventional implant site preparation<br>* twist drills will be used to create implant bone ostectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| implant survival rate | how many implant are present in mouth | two years after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| implant success rate | implant stable and fulfilling success criteria | two years after surgery | 
| biomechanical complications | every complication linked to the crown, implant abutment structure | two years after surgery | 
| marginal bone loss | radiographically assessed bone level | two years after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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implant, piezoelectric, drills, immediate loading