Clincosm LogoSign in Get a demo

Osseodensification Drills Versus Piezoelectric Surgery

Sponsor
International Piezosurgery Academy (Other)
Overall Status
Completed
CT.gov ID
NCT05410405
Collaborator
University of Foggia (Other), University of Trieste (Other)
27
Enrollment
2
Locations
2
Arms
17
Actual Duration (Months)
13.5
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: implant site preparation
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
27 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
split mouthsplit mouth
Masking:
Single (Investigator)
Masking Description:
implant stability assessment was blinded
Primary Purpose:
Treatment
Official Title:
Changes in Implant Stability Using Different Site Preparation Techniques: Osseodensification Drills Versus Piezoelectric Surgery. A Multicenter Randomized Controlled Clinical Trial
Actual Study Start Date :
Nov 15, 2020
Actual Primary Completion Date :
Sep 15, 2021
Actual Study Completion Date :
Apr 15, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: 8 millimeter implants

implant insertion with piezo surgical osteotomy and with osseodensification drills

Procedure: implant site preparation
piezoelectric bone surgery osseodensification drills
Other Names:
  • implant insertion

    		•
    Experimental: 10 millimeter implants

    implant insertion with piezo surgical osteotomy and with osseodensification drills

    Procedure: implant site preparation
    piezoelectric bone surgery osseodensification drills
    Other Names:
  • implant insertion

    		•

    Outcome Measures

    Primary Outcome Measures

    1. implant insertion torque [at implant insertion]

      insertion torque

    2. implant stability quotient [at implant insertion]

      resonance frequency

    Secondary Outcome Measures

    1. implant secondary stability [7 days after implant insertion]

      resonance frequency

    2. implant secondary stability [14 days after implant insertion]

      resonance frequency

    3. implant secondary stability [21 days after implant insertion]

      resonance frequency

    4. implant secondary stability [28 days after implant insertion]

      resonance frequency

    5. implant secondary stability [2 months after implant insertion]

      resonance frequency

    6. implant secondary stability [3 months after implant insertion]

      resonance frequency

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hesire Cassano allo Ionio CS Italy 87011
    2 Piezosurgery Academy Parma Italy 43100

    Sponsors and Collaborators

    • International Piezosurgery Academy
    • University of Foggia
    • University of Trieste

    Investigators

    • Study Director: Claudio Stacchi, Dr, International Piezoelectric Surgery Academy

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    International Piezosurgery Academy
    ClinicalTrials.gov Identifier:
    NCT05410405
    Other Study ID Numbers:
    • piezodensi
    First Posted:
    Jun 8, 2022
    Last Update Posted:
    Jun 8, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Atrophy

    Study Results

    No Results Posted as of Jun 8, 2022