Skip to main content
OpenTrials
Completed

NCT Number: NCT05410405

Osseodensification Drills Versus Piezoelectric Surgery

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Edentulous; Alveolar Process, Atrophy Atrophy Mouth Diseases Mouth, Edentulous Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Stomatognathic Diseases Tooth Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hesire, Cassano Allo Ionio, CS, Italy

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

implant site preparation

Procedure

piezoelectric bone surgery osseodensification drills

Other names: implant insertion

Primary outcomes

  1. implant insertion torque

    Time frame: at implant insertion

    insertion torque

  2. implant stability quotient

    Time frame: at implant insertion

    resonance frequency

Secondary outcomes

  1. implant secondary stability

    Time frame: 7 days after implant insertion

    resonance frequency

  2. implant secondary stability

    Time frame: 14 days after implant insertion

    resonance frequency

  3. implant secondary stability

    Time frame: 21 days after implant insertion

    resonance frequency

  4. implant secondary stability

    Time frame: 28 days after implant insertion

    resonance frequency

  5. implant secondary stability

    Time frame: 2 months after implant insertion

    resonance frequency

  6. implant secondary stability

    Time frame: 3 months after implant insertion

    resonance frequency

Sponsors and collaborators

Lead sponsor

International Piezosurgery Academy

Other

Collaborators

  • University of Foggia
  • University of Trieste

Registry information

Official study title

Changes in Implant Stability Using Different Site Preparation Techniques: Osseodensification Drills Versus Piezoelectric Surgery. A Multicenter Randomized Controlled Clinical Trial

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Jun 8, 2022
Registry last updated
Jun 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.