Osseodensification Drills Versus Piezoelectric Surgery

Edentulous; Alveolar Process, Atrophy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05410405
• Other study ID #: piezodensi
• Status: Completed
• Phase: N/A
• Start date: November 15, 2020
• Est. completion date: April 15, 2022

Study information

• Verified date: June 2022
• Source: International Piezosurgery Academy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: April 15, 2022
• Est. primary completion date: September 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Atrophy
• Edentulous; Alveolar Process, Atrophy

Intervention

Procedure:
• implant site preparation
piezoelectric bone surgery osseodensification drills

Locations

Country	Name	City	State
Italy	Hesire	Cassano allo Ionio	CS
Italy	Piezosurgery Academy	Parma

Sponsors (3)

Lead Sponsor	Collaborator
International Piezosurgery Academy	University of Foggia, University of Trieste

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	implant insertion torque	insertion torque	at implant insertion
Primary	implant stability quotient	resonance frequency	at implant insertion
Secondary	implant secondary stability	resonance frequency	7 days after implant insertion
Secondary	implant secondary stability	resonance frequency	14 days after implant insertion
Secondary	implant secondary stability	resonance frequency	21 days after implant insertion
Secondary	implant secondary stability	resonance frequency	28 days after implant insertion
Secondary	implant secondary stability	resonance frequency	2 months after implant insertion
Secondary	implant secondary stability	resonance frequency	3 months after implant insertion