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

March 24, 2023 updated by: Dr Prabhuji MLV, Krishnadevaraya College of Dental Sciences & Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Karnataka
      • Bengaluru, Karnataka, India, 562157
        • Dr. Roxanne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Cell cultures with a confluency of 70%-80%

Exclusion Criteria:

  • Contaminated cell cultures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Scratch assay
Time Frame: 72hours
cell migration
72hours
MTT Assay and ATP analysis
Time Frame: 74hrs
Cell viability
74hrs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Krishnadevaraya College of Dental Sciences & Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 22, 2021

Primary Completion (Actual)

August 17, 2022

Study Completion (Actual)

November 6, 2022

Study Registration Dates

First Submitted

February 6, 2023

First Submitted That Met QC Criteria

March 24, 2023

First Posted (Actual)

April 6, 2023

Study Record Updates

Last Update Posted (Actual)

April 6, 2023

Last Update Submitted That Met QC Criteria

March 24, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02_D012_112292

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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