Osseodensification Drills Versus Piezoelectric Surgery

NCT ID: NCT05410405

Last Updated: 2022-06-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-15

Study Completion Date

2022-04-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Edentulous; Alveolar Process, Atrophy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

split mouth
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators
implant stability assessment was blinded

Study Groups

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8 millimeter implants

implant insertion with piezo surgical osteotomy and with osseodensification drills

Group Type EXPERIMENTAL

implant site preparation

Intervention Type PROCEDURE

piezoelectric bone surgery osseodensification drills

10 millimeter implants

implant insertion with piezo surgical osteotomy and with osseodensification drills

Group Type EXPERIMENTAL

implant site preparation

Intervention Type PROCEDURE

piezoelectric bone surgery osseodensification drills

Interventions

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implant site preparation

piezoelectric bone surgery osseodensification drills

Intervention Type PROCEDURE

Other Intervention Names

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implant insertion

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Foggia

OTHER

Sponsor Role collaborator

University of Trieste

OTHER

Sponsor Role collaborator

International Piezosurgery Academy

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Claudio Stacchi, Dr

Role: STUDY_DIRECTOR

International Piezoelectric Surgery Academy

Locations

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Hesire

Cassano Allo Ionio, CS, Italy

Site Status

Piezosurgery Academy

Parma, , Italy

Site Status

Countries

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Italy

Other Identifiers

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piezodensi

Identifier Type: -

Identifier Source: org_study_id

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