Osseodensification Drills Versus Piezoelectric Surgery

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

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.

Study Overview

• Status: Completed
• Conditions: Edentulous; Alveolar Process, Atrophy
• Intervention / Treatment: Procedure: implant site preparation

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 Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
implant insertion torque	insertion torque	at implant insertion
implant stability quotient	resonance frequency	at implant insertion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
implant secondary stability	resonance frequency	7 days after implant insertion
implant secondary stability	resonance frequency	14 days after implant insertion
implant secondary stability	resonance frequency	21 days after implant insertion
implant secondary stability	resonance frequency	28 days after implant insertion
implant secondary stability	resonance frequency	2 months after implant insertion
implant secondary stability	resonance frequency	3 months after implant insertion

Collaborators and Investigators

• Sponsor: International Piezosurgery Academy
• Collaborators: University of Trieste; University of Foggia
• Investigators: Study Director: Claudio Stacchi, Dr, International Piezoelectric surgery Academy

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2020
• Primary Completion (Actual): September 15, 2021
• Study Completion (Actual): April 15, 2022

Study Registration Dates

• First Submitted: May 31, 2022
• First Submitted That Met QC Criteria: June 4, 2022
• First Posted (Actual): June 8, 2022

Study Record Updates

• Last Update Posted (Actual): June 8, 2022
• Last Update Submitted That Met QC Criteria: June 4, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Atrophy
• Other Study ID Numbers: piezodensi

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: no sharing is planned

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No