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ESWT: Extracorporeal Shock Wave Therapy on Osteoblast-Like Cells In- Vitro Study

Sponsor
Krishnadevaraya College of Dental Sciences & Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05801887
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
12.5
Actual Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The idea of treating different deformities or diseases in the maxillofacial region with Extracorporeal Shockwave Therapy (ESWT) has recently become popular. It has been widely used in medical practice for the management of urolithiasis, cholelithiasis and in haead and neck region for sialolithiasis. The present study 'Extracorporeal Shock Wave Therapy on Osteoblast-Like Cells In-vitro study' will be done to explore and evaluate the effect of shockwaves. Further, Osteoblast-like cells will be assessed for Cell - Cell interaction and Cell Viability. It will be assessed using a scratch assay, Mtt assay and ATP analysis.

Condition or Disease Intervention/Treatment Phase
  • Device: Extracorporeal shockwave device
  • Device: No ESWT
 N/A

Detailed Description

Introduction:

Extracorporeal Shockwave Therapy (ESWT) has recently become popular. Shockwave has been widely used in medical practice for the management of urolithiasis, cholelithiasis and in haead and neck region for sialolithiasis.

Aim:

This study 'Extracorporeal Shock Wave Therapy on Osteoblast-Like Cells In-vitro study' will be done to explore and evaluate the effect of shockwaves. Further, Osteoblast-like cells will be assessed for Cell - Cell interaction and Cell Viability.

Methodology:

In this in-vitro study, 20 Osteoblast - like cells will be included. 10 samples to be considered for Control group and the remaining 10 samples considered as Test group. Extracorporeal shockwave will be applied to the Test samples. They will be further analysed using wound scratch assay which is used to assess Cell proliferative rate and scratch closure through live imaging. MTT assay and ATP assay used to determine Cell viability after exposure to shockwaves. The cell migration and cell viability after exposure to shockwaves will determine its effects on osteoblast-like cells.

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
test group - application of shockwave on osteoblast control group - No shockwave on osteoblasttest group - application of shockwave on osteoblast control group - No shockwave on osteoblast
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Extracorporeal Shock Wave Therapy on Osteoblast-Like Cells In- Vitro Study
Actual Study Start Date :
Oct 22, 2021
Actual Primary Completion Date :
Aug 17, 2022
Actual Study Completion Date :
Nov 6, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Shockwave treated group

The osteoblast like cells are treated with shockwaves

Device: Extracorporeal shockwave device
Extracorporeal shockwave device generates true shock waves which are characterized by a sudden rise in pressure followed by an exponential decay. This is different from the commercially available shockwave devices in which they use piezoelectric based mechanisms which generate high frequency waves.
Other Names:
  • ESWT

    		•
    Placebo Comparator: No shockwave group

    The osteoblast like cells are not exposed to shockwaves

    Device: No ESWT
    the osteoblast like cells are not exposed to shockwaves
    Other Names:
  • shockwave

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Scratch assay [72hours]

      cell migration

    2. MTT Assay and ATP analysis [74hrs]

      Cell viability

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Cell cultures with a confluency of 70%-80%
    Exclusion Criteria:
    • Contaminated cell cultures

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dr. Roxanne Bengaluru Karnataka India 562157

    Sponsors and Collaborators

    • Krishnadevaraya College of Dental Sciences & Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr Prabhuji MLV, Clinical Professor, Krishnadevaraya College of Dental Sciences & Hospital
    ClinicalTrials.gov Identifier:
    NCT05801887
    Other Study ID Numbers:
    • 02_D012_112292
    First Posted:
    Apr 6, 2023
    Last Update Posted:
    Apr 6, 2023
    Last Verified:
    Mar 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Dr Prabhuji MLV, Clinical Professor, Krishnadevaraya College of Dental Sciences & Hospital
    ESWT
    Cell proliferation
    Cell viability
    Additional relevant MeSH terms:
    Osteosarcoma

    Study Results

    No Results Posted as of Apr 6, 2023