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Conventional and Ultrasonic Implant Site Preparation (PI-DRI)

Primary Purpose

Bone Atrophy, Alveolar

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
ultrasound implant site preparation
conventional implant site preparation
Sponsored by
International Piezosurgery Academy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bone Atrophy, Alveolar focused on measuring implant, piezoelectric, drills, immediate loading

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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%)

Sites / Locations

  • Piezosurgery Academy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

edentulism side 1

edentulism side 2

Arm Description

ultrasound implant site preparation

conventional implant site preparation

Outcomes

Primary Outcome Measures

implant survival rate
how many implant are present in mouth

Secondary Outcome Measures

implant success rate
implant stable and fulfilling success criteria
biomechanical complications
every complication linked to the crown, implant abutment structure
marginal bone loss
radiographically assessed bone level

Full Information

First Posted
November 23, 2017
Last Updated
November 28, 2017
Sponsor
International Piezosurgery Academy
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1. Study Identification

Unique Protocol Identification Number
NCT03357406
Brief Title
Conventional and Ultrasonic Implant Site Preparation
Acronym
PI-DRI
Official Title
Immediate Loading After Conventional and Ultrasonic Implant Site Preparation: a Multicenter Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
February 15, 2016 (Actual)
Primary Completion Date
July 15, 2017 (Actual)
Study Completion Date
November 15, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
International Piezosurgery Academy

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Atrophy, Alveolar
Keywords
implant, piezoelectric, drills, immediate loading

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Split mouth design
Masking
InvestigatorOutcomes Assessor
Masking Description
treatment method is masked till the surgical procedure, during which, both surgeon and patient are informed
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
edentulism side 1
Arm Type
Experimental
Arm Description
ultrasound implant site preparation
Arm Title
edentulism side 2
Arm Type
Active Comparator
Arm Description
conventional implant site preparation
Intervention Type
Procedure
Intervention Name(s)
ultrasound implant site preparation
Intervention Description
piezoelectric bone surgery will be used to create implant bone ostectomy
Intervention Type
Procedure
Intervention Name(s)
conventional implant site preparation
Intervention Description
twist drills will be used to create implant bone ostectomy
Primary Outcome Measure Information:
Title
implant survival rate
Description
how many implant are present in mouth
Time Frame
two years after surgery
Secondary Outcome Measure Information:
Title
implant success rate
Description
implant stable and fulfilling success criteria
Time Frame
two years after surgery
Title
biomechanical complications
Description
every complication linked to the crown, implant abutment structure
Time Frame
two years after surgery
Title
marginal bone loss
Description
radiographically assessed bone level
Time Frame
two years after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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%)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudio Stacchi, Dr
Organizational Affiliation
Piezosurgery Academy
Official's Role
Study Director
Facility Information:
Facility Name
Piezosurgery Academy
City
Parma
ZIP/Postal Code
43100
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24396835
Citation
Vercellotti T, Stacchi C, Russo C, Rebaudi A, Vincenzi G, Pratella U, Baldi D, Mozzati M, Monagheddu C, Sentineri R, Cuneo T, Di Alberti L, Carossa S, Schierano G. Ultrasonic implant site preparation using piezosurgery: a multicenter case series study analyzing 3,579 implants with a 1- to 3-year follow-up. Int J Periodontics Restorative Dent. 2014 Jan-Feb;34(1):11-8. doi: 10.11607/prd.1860.
Results Reference
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PubMed Identifier
19160225
Citation
Esposito M, Grusovin MG, Achille H, Coulthard P, Worthington HV. Interventions for replacing missing teeth: different times for loading dental implants. Cochrane Database Syst Rev. 2009 Jan 21;(1):CD003878. doi: 10.1002/14651858.CD003878.pub4.
Results Reference
background
PubMed Identifier
21599832
Citation
Khayat PG, Arnal HM, Tourbah BI, Sennerby L. Clinical outcome of dental implants placed with high insertion torques (up to 176 Ncm). Clin Implant Dent Relat Res. 2013 Apr;15(2):227-33. doi: 10.1111/j.1708-8208.2011.00351.x. Epub 2011 May 20.
Results Reference
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Conventional and Ultrasonic Implant Site Preparation

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