Piezo-surgery Versus Conventional Drills

NCT05753917 | Completed

• 1 other identifier: 16053
• Study Type: interventional
• Target: 6
• Locations: 0 countries
• Sites: N/A

Brief Summary

Purpose: The aim of this RCT was to evaluate and compare histomorphometric and immunohistochemical characteristics of peri-implant bone tissue after implant site preparation using piezoelectric tips versus conventional drills. Material and Methods: A split-mouth protocol was carried out on 6 patients with bilateral partial edentulism. A total of 12 alveolar ridges were randomized into two groups: 6 control sites (Group B) with conventional drills preparation (Drill-group) and 6 test sites (Group A) treated by piezoelectric implant inserts preparation (Piezo-group). At 28 days after surgery (T1), in both group, one study-fixtures with 0.5 mm of peri-implant bone tissue were explanted and processed for the histological, histomorphometrical and immunoistochemical analysis. For each sample Inflammatory infiltrates, necrotic bone (Zone 1), woven and newly formed bone (Zone 2), native bone (Zone 3), CD31 (cluster of differentiation 31) and SATB2 (special AT-rich sequence-binding protein necrotic bone undergoing remodeling) were evaluated.

Conditions

Bone Formation

Keywords

piezo-surgery; Implant surgery; histological analysis; Conventional drills

Outcome Measures

Primary Outcomes (1)

• Zone 1 (necrotic bone undergoing remodeling)

  Hystological sections were screened at high magnification (400×), and areas of necrotic bone lacking live osteocytes were automatically outlined with a pointer and photographed using a digital Peltier-cooled camera (Q-color 3; resolution 1,376 x 1,032 pixels; Olympus). Histological and histomorphometric analyses were performed on the central regions of each sample and Image J software (NIH, Bethesda, MD, USA) was used to determine the presence and type of inflammatory infiltrate, and to quantify morphometric parameters. Value expressed as percentage

  after 28 days of healing

Secondary Outcomes (4)

• Zone 2 (woven and newly formed bone)

  after 28 days of healing

• Zone 3 (native bone)

  after 28 days of healing

• CD31 (marker of vascular endothelium differentiation and neo-osteogenesis)

  after 28 days of healing

• SATB2

  after 28 days of healing

Study Arms (2)

Group A

EXPERIMENTAL

piezoelectric device with IM1, IM2, IM2-3, or IM3 piezo-inserts according to the manufacturer's protocol (Piezosurgery, Mectron Medical Technology, Carasco, Italy). One or two implants were placed in each edentulous ridge along with an additional 3.3 x 8.5 mm implant, termed a "study fixture", in an adjacent area

Device: Piezo-surgery insert OR Conventional Drills

Group B

ACTIVE COMPARATOR

In Group B, all implant sites were prepared with conventional drills according to the manufacturer's protocol (Premium, Sweden \& Martina, Due Carrare, Padova, Italy); similarly to group A, one or two implants were placed in each edentulous ridge, and an additional 3.3 x 8.5 mm "study-fixture" was placed in the adjacent area.

Device: Piezo-surgery insert OR Conventional Drills

Interventions

Piezo-surgery insert OR Conventional Drills DEVICE

piezo-surgery: Group A (piezoelectric device with IM1, IM2, IM2-3, or IM3 piezo-inserts according to the manufacturer's protocol (Piezosurgery, Mectron Medical Technology, Carasco, Italy) Conventional drill: Group B (conventional drills according to the manufacturer's protocol (Premium, Sweden \& Martina, Due Carrare, Padova, Italy)

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• bilateral edentulous sites in mandibles or maxillae that did not require bone regeneration prior to implant placement;
• American Society of Anesthesiologists (ASA) status 1;
• the capacity to understand and accept the conditions of the study;
• continuing participation for at least 1 year of follow-up.

You may not qualify if:

• Previous bone augmentation of the sites to be treated;
• poor oral hygiene;
• smoking \> 10 cigarettes/day;
• abuse of alcohol or drugs;
• pregnancy;
• acute local or systemic infection;
• uncontrolled diabetes or other metabolic disease;
• severe hepatic or renal dysfunction;
• HIV, HBV, or HCV infection;
• chemotherapy or radiotherapy within the past 5 years;
• current immunosuppressive therapy;
• an autoimmune disorder;
• bisphosphonate therapy

Sponsors & Collaborators

• GBR Academy: lead

Study Officials

• Alessandro Cucchi

  GBR Academy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Alessandro Cucchi

Model Details: Pilot, parallel-group, single-blinded, split-mouth, randomized clinical trial

Study Record Dates

• First Submitted: February 23, 2023
• First Posted: March 3, 2023
• Study Start: December 12, 2016
• Primary Completion: December 12, 2019
• Study Completion: December 12, 2020
• Last Updated: April 28, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 6 months
• Access Criteria: Contact the authors at the following email addresses: Alessandro Cucchi: dr.cucchi@hotmail.com Elisabetta Vignudelli: elisabetta.vignudelli@unibo.it