Conventional and Ultrasonic Implant Site Preparation (PI-DRI)

November 28, 2017 updated by: Mr. Claudio Stacchi, DDS, MSc, International Piezosurgery Academy

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

multi center study with randomized controlled trial design, split mouth

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Parma, Italy, 43100
        • Piezosurgery Academy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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%)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

International Piezosurgery Academy

Investigators

  • Study Director: Claudio Stacchi, Dr, Piezosurgery Academy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2016

Primary Completion (Actual)

July 15, 2017

Study Completion (Actual)

November 15, 2017

Study Registration Dates

First Submitted

November 23, 2017

First Submitted That Met QC Criteria

November 28, 2017

First Posted (Actual)

November 29, 2017

Study Record Updates

Last Update Posted (Actual)

November 29, 2017

Last Update Submitted That Met QC Criteria

November 28, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • piezo-drills

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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