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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05801887
Other study ID # 02_D012_112292
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 22, 2021
Est. completion date November 6, 2022

Study information

Verified date March 2023
Source Krishnadevaraya College of Dental Sciences & Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date November 6, 2022
Est. primary completion date August 17, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Cell cultures with a confluency of 70%-80% Exclusion Criteria: - Contaminated cell cultures

Study Design


Related Conditions & MeSH terms


Intervention

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.
No ESWT
the osteoblast like cells are not exposed to shockwaves

Locations

Country Name City State
India Dr. Roxanne Bengaluru Karnataka

Sponsors (1)

Lead Sponsor Collaborator
Krishnadevaraya College of Dental Sciences & Hospital

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary Scratch assay cell migration 72hours
Primary MTT Assay and ATP analysis Cell viability 74hrs
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