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PIEZOSURGERY VERSUS CONVENTIONAL DRILLS: HISTOLOGICAL RCT

Sponsor
GBR Academy (Other)
Overall Status
Completed
CT.gov ID
NCT05753917
Collaborator
(none)
6
Enrollment
2
Arms
48
Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Piezo-surgery insert OR Conventional Drills
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
6 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Pilot, parallel-group, single-blinded, split-mouth, randomized clinical trialPilot, parallel-group, single-blinded, split-mouth, randomized clinical trial
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
HISTOMORPHOMETRIC AND IMMUNOHISTOCHEMICAL EVALUATION OF BONE HEALING AROUND IMPLANTS PLACED USING PIEZOSURGERY VERSUS CONVENTIONAL DRILLS: A SPLIT MOUTH RANDOMIZED CLINICAL TRIAL.
Actual Study Start Date :
Dec 12, 2016
Actual Primary Completion Date :
Dec 12, 2019
Actual Study Completion Date :
Dec 12, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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). 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
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)
Active Comparator: Group B

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
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)

Outcome Measures

Primary Outcome Measures

  1. Zone 1 [after 28 days of healing]

    necrotic bone undergoing remodeling

Secondary Outcome Measures

  1. Zone 2 [after 28 days of healing]

    woven and newly formed bone

  2. Zone 3 [after 28 days of healing]

    native bone

  3. CD31 [after 28 days of healing]

    a marker of vascular endothelium differentiation and neo-osteogenesis

  4. SATB2 [after 28 days of healing]

    a marker of osteoblastic cell differentiation and osteogenesis

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Criteria: Inclusion Criteria:

  1. bilateral edentulous sites in mandibles or maxillae that did not require bone regeneration prior to implant placement;

  2. American Society of Anesthesiologists (ASA) status 1;

  3. the capacity to understand and accept the conditions of the study;

  4. continuing participation for at least 1 year of follow-up.

Exclusion Criteria:

  1. Previous bone augmentation of the sites to be treated;

  2. poor oral hygiene;

  3. smoking > 10 cigarettes/day;

  4. abuse of alcohol or drugs;

  5. pregnancy;

  6. acute local or systemic infection;

  7. uncontrolled diabetes or other metabolic disease;

  8. severe hepatic or renal dysfunction;

  9. HIV, HBV, or HCV infection;

  10. chemotherapy or radiotherapy within the past 5 years;

  11. current immunosuppressive therapy;

  12. an autoimmune disorder;

  13. bisphosphonate therapy

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • GBR Academy

Investigators

  • Principal Investigator: Alessandro Cucchi, GBR Academy

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alessandro Cucchi, Alessandro Cucchi, GBR Academy
ClinicalTrials.gov Identifier:
NCT05753917
Other Study ID Numbers:
  • 16053
First Posted:
Mar 3, 2023
Last Update Posted:
Mar 3, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Alessandro Cucchi, Alessandro Cucchi, GBR Academy
piezo-surgery
Implant surgery
histological analysis
Conventional drills

Study Results

No Results Posted as of Mar 3, 2023