Osseodensification Drills Versus Piezoelectric Surgery

Study Overview
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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.

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

Conditions
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Edentulous; Alveolar Process, Atrophy

Intervention / Treatment
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* Procedure: implant site preparation


Participation Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: split mouth
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 8 millimeter implants<br>implant insertion with piezo surgical osteotomy and with osseodensification drills | Procedure: implant site preparation<br>* piezoelectric bone surgery osseodensification drills<br>* Other names: implant insertion;|
| Experimental: 10 millimeter implants<br>implant insertion with piezo surgical osteotomy and with osseodensification drills | Procedure: implant site preparation<br>* piezoelectric bone surgery osseodensification drills<br>* Other names: implant insertion;|

What is the study measuring?
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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 |