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

Primary Purpose

Osteosarcoma

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Extracorporeal shockwave device
No ESWT
Sponsored by
Krishnadevaraya College of Dental Sciences & Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteosarcoma focused on measuring ESWT, Cell proliferation, Cell viability

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Cell cultures with a confluency of 70%-80% Exclusion Criteria: Contaminated cell cultures

Sites / Locations

  • Dr. Roxanne

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Shockwave treated group

No shockwave group

Arm Description

The osteoblast like cells are treated with shockwaves

The osteoblast like cells are not exposed to shockwaves

Outcomes

Primary Outcome Measures

Scratch assay
cell migration
MTT Assay and ATP analysis
Cell viability

Secondary Outcome Measures

Full Information

First Posted
February 6, 2023
Last Updated
March 24, 2023
Sponsor
Krishnadevaraya College of Dental Sciences & Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05801887
Brief Title
Extracorporeal Shock Wave Therapy on Osteoblast-Like Cells In- Vitro Study
Acronym
ESWT
Official Title
Extracorporeal Shock Wave Therapy on Osteoblast-Like Cells In- Vitro Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
October 22, 2021 (Actual)
Primary Completion Date
August 17, 2022 (Actual)
Study Completion Date
November 6, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Krishnadevaraya College of Dental Sciences & Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteosarcoma
Keywords
ESWT, Cell proliferation, Cell viability

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
test group - application of shockwave on osteoblast control group - No shockwave on osteoblast
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Shockwave treated group
Arm Type
Experimental
Arm Description
The osteoblast like cells are treated with shockwaves
Arm Title
No shockwave group
Arm Type
Placebo Comparator
Arm Description
The osteoblast like cells are not exposed to shockwaves
Intervention Type
Device
Intervention Name(s)
Extracorporeal shockwave device
Other Intervention Name(s)
ESWT
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
No ESWT
Other Intervention Name(s)
shockwave
Intervention Description
the osteoblast like cells are not exposed to shockwaves
Primary Outcome Measure Information:
Title
Scratch assay
Description
cell migration
Time Frame
72hours
Title
MTT Assay and ATP analysis
Description
Cell viability
Time Frame
74hrs

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Cell cultures with a confluency of 70%-80% Exclusion Criteria: Contaminated cell cultures
Facility Information:
Facility Name
Dr. Roxanne
City
Bengaluru
State/Province
Karnataka
ZIP/Postal Code
562157
Country
India

12. IPD Sharing Statement

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

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