Osseodensification Drills Versus Piezoelectric Surgery
Primary Purpose
Edentulous; Alveolar Process, Atrophy
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
implant site preparation
Sponsored by
About this trial
This is an interventional treatment trial for Edentulous; Alveolar Process, Atrophy
Eligibility Criteria
Inclusion Criteria:
- bilateral single maxillary edentulism
Exclusion Criteria:
- smoking habit
- history of periodontal disease
- uncontrolled diabetes
- pregnancy or breastfeeding
- head and neck radiotherapy or chemotherapy
- bone antiresorptive therapy
- coagulopaties
Sites / Locations
- Hesire
- Piezosurgery Academy
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
8 millimeter implants
10 millimeter implants
Arm Description
implant insertion with piezo surgical osteotomy and with osseodensification drills
implant insertion with piezo surgical osteotomy and with osseodensification drills
Outcomes
Primary Outcome Measures
implant insertion torque
insertion torque
implant stability quotient
resonance frequency
Secondary Outcome Measures
implant secondary stability
resonance frequency
implant secondary stability
resonance frequency
implant secondary stability
resonance frequency
implant secondary stability
resonance frequency
implant secondary stability
resonance frequency
implant secondary stability
resonance frequency
Full Information
NCT ID
NCT05410405
First Posted
May 31, 2022
Last Updated
June 4, 2022
Sponsor
International Piezosurgery Academy
Collaborators
University of Foggia, University of Trieste
1. Study Identification
Unique Protocol Identification Number
NCT05410405
Brief Title
Osseodensification Drills Versus Piezoelectric Surgery
Official Title
Changes in Implant Stability Using Different Site Preparation Techniques: Osseodensification Drills Versus Piezoelectric Surgery. A Multicenter Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
November 15, 2020 (Actual)
Primary Completion Date
September 15, 2021 (Actual)
Study Completion Date
April 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
International Piezosurgery Academy
Collaborators
University of Foggia, University of Trieste
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
implant stability is the first requirement for implant success. the aim is to assess whether different implant site preparation technique may impact the value of the primary stability.
Detailed Description
Impianti stability represents one of the most fundamental issue for implant success. Different techniques of implant site preparation are available such as twist drill, osteotome, piezosurgery and lastly, osseodensification. Due to their different approach an biological rationale, piezosurgery and osseodensification might show diverse impact on implant first and secondary stability, therefore the aim of the present study was the assessment of primary and secondary stability changes of values between implant sites prepared with piezoelectric bone surgery and with specific osseodensification drills.
Patients with bilateral single maxillary edentulism will randomly receive implant site preparation with piezoelectric approach or with osseodensification drills. standardized implants will be therefore inserted and primary stability will be assessed at the time of implant insertion and during the subsequent timepoints.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Edentulous; Alveolar Process, Atrophy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
split mouth
Masking
Investigator
Masking Description
implant stability assessment was blinded
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
8 millimeter implants
Arm Type
Experimental
Arm Description
implant insertion with piezo surgical osteotomy and with osseodensification drills
Arm Title
10 millimeter implants
Arm Type
Experimental
Arm Description
implant insertion with piezo surgical osteotomy and with osseodensification drills
Intervention Type
Procedure
Intervention Name(s)
implant site preparation
Other Intervention Name(s)
implant insertion
Intervention Description
piezoelectric bone surgery osseodensification drills
Primary Outcome Measure Information:
Title
implant insertion torque
Description
insertion torque
Time Frame
at implant insertion
Title
implant stability quotient
Description
resonance frequency
Time Frame
at implant insertion
Secondary Outcome Measure Information:
Title
implant secondary stability
Description
resonance frequency
Time Frame
7 days after implant insertion
Title
implant secondary stability
Description
resonance frequency
Time Frame
14 days after implant insertion
Title
implant secondary stability
Description
resonance frequency
Time Frame
21 days after implant insertion
Title
implant secondary stability
Description
resonance frequency
Time Frame
28 days after implant insertion
Title
implant secondary stability
Description
resonance frequency
Time Frame
2 months after implant insertion
Title
implant secondary stability
Description
resonance frequency
Time Frame
3 months after implant insertion
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
bilateral single maxillary edentulism
Exclusion Criteria:
smoking habit
history of periodontal disease
uncontrolled diabetes
pregnancy or breastfeeding
head and neck radiotherapy or chemotherapy
bone antiresorptive therapy
coagulopaties
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudio Stacchi, Dr
Organizational Affiliation
International Piezoelectric Surgery Academy
Official's Role
Study Director
Facility Information:
Facility Name
Hesire
City
Cassano allo Ionio
State/Province
CS
ZIP/Postal Code
87011
Country
Italy
Facility Name
Piezosurgery Academy
City
Parma
ZIP/Postal Code
43100
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
no sharing is planned
Learn more about this trial
Osseodensification Drills Versus Piezoelectric Surgery
We'll reach out to this number within 24 hrs