CClinicalTrials.gg
CompletedNCT05410405Updated Jun 8, 2022

Osseodensification Drills Versus Piezoelectric Surgery

An interventional study of implant site preparation in Edentulous; Alveolar Process, Atrophy, sponsored by International Piezosurgery Academy. Completed at 2 sites in Italy. Per ClinicalTrials.gov, last updated 2022-06-08.

Sponsored by International Piezosurgery Academy · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 6 months after the study started (first participant enrolled Nov 2020, registered May 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
27
Allocation
Randomized
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Edentulous; Alveolar Process, Atrophy

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03

In context

Atrophy

828 studies on the registry are indexed under Atrophy; 122 are open to participants now.

This study's enrollment of 27 is below the median of 34 across 603 interventional studies indexed under Atrophy.

Browse Atrophy studies →

Lead sponsor

International Piezosurgery Academy is the lead sponsor of 24 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • bilateral single maxillary edentulism

Exclusion criteria

Exclusion Criteria:

  • smoking habit
  • history of periodontal disease
  • uncontrolled diabetes
  • pregnancy or breastfeeding
  • head and neck radiotherapy or chemotherapy
  • bone antiresorptive therapy
  • coagulopaties
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
27 participants (actual)

Study arms

  • Experimental
    8 millimeter implants

    implant insertion with piezo surgical osteotomy and with osseodensification drills

    Procedure: implant site preparation

  • Experimental
    10 millimeter implants

    implant insertion with piezo surgical osteotomy and with osseodensification drills

    Procedure: implant site preparation

Interventions

  • Procedureimplant site preparation

    piezoelectric bone surgery osseodensification drills

    Also known as: implant insertion

06

What researchers measure

Primary outcomes

  1. implant insertion torque

    insertion torque

    Time frame: at implant insertion

  2. implant stability quotient

    resonance frequency

    Time frame: at implant insertion

Secondary outcomes

  1. implant secondary stability

    resonance frequency

    Time frame: 7 days after implant insertion

  2. implant secondary stability

    resonance frequency

    Time frame: 14 days after implant insertion

  3. implant secondary stability

    resonance frequency

    Time frame: 21 days after implant insertion

  4. implant secondary stability

    resonance frequency

    Time frame: 28 days after implant insertion

  5. implant secondary stability

    resonance frequency

    Time frame: 2 months after implant insertion

  6. implant secondary stability

    resonance frequency

    Time frame: 3 months after implant insertion

07

Study locations

2 sites
  • Hesire
    Cassano allo Ionio, CS 87011, Italy
  • Piezosurgery Academy
    Parma, 43100, Italy
08

References and documents

Individual participant data

Plan to share: No — no sharing is planned

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 8, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05410405
Lead sponsor
International Piezosurgery Academy
Collaborators
University of Foggia, University of Trieste
Responsible party
Sponsor
First posted
Jun 8, 2022
Start date
Nov 15, 2020
Primary completion
Sep 15, 2021
Completion
Apr 15, 2022
Last update
Jun 8, 2022

Study contacts

Claudio Stacchi, Dr
study director · International Piezoelectric Surgery Academy

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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