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CompletedNCT05801887ESWTUpdated Apr 6, 2023

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

An interventional study of Extracorporeal shockwave device and No ESWT in Osteosarcoma, sponsored by Krishnadevaraya College of Dental Sciences & Hospital. Completed at 1 site in India. Per ClinicalTrials.gov, last updated 2023-04-06.

Sponsored by Krishnadevaraya College of Dental Sciences & Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 3 months after the study started (first participant enrolled Oct 2021, registered Feb 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Non-randomized
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Osteosarcoma

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Keywords

  • ESWT
  • Cell proliferation
  • Cell viability
03

In context

Osteosarcoma

437 studies on the registry are indexed under Osteosarcoma; 116 are open to participants now.

This study's enrollment of 20 is below the median of 42 across 325 interventional studies indexed under Osteosarcoma.

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Lead sponsor

Krishnadevaraya College of Dental Sciences & Hospital is the lead sponsor of 51 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Contaminated cell cultures
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Shockwave treated group

    The osteoblast like cells are treated with shockwaves

    Device: Extracorporeal shockwave device

  • Placebo comparator
    No shockwave group

    The osteoblast like cells are not exposed to shockwaves

    Device: No ESWT

Interventions

  • DeviceExtracorporeal 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.

    Also known as: ESWT

  • DeviceNo ESWT

    the osteoblast like cells are not exposed to shockwaves

    Also known as: shockwave

06

What researchers measure

Primary outcomes

  1. Scratch assay

    cell migration

    Time frame: 72hours

  2. MTT Assay and ATP analysis

    Cell viability

    Time frame: 74hrs

07

Study locations

1 site
  • Dr. Roxanne
    Bengaluru, Karnataka 562157, India
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05801887
Lead sponsor
Krishnadevaraya College of Dental Sciences & Hospital
Responsible party
Dr Prabhuji MLV (Clinical Professor, Krishnadevaraya College of Dental Sciences & Hospital) — Principal investigator
First posted
Apr 6, 2023
Start date
Oct 22, 2021
Primary completion
Aug 17, 2022
Completion
Nov 6, 2022
Last update
Apr 6, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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