NCT05801887

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 22, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 17, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 6, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 6, 2023

Completed
Last Updated

April 6, 2023

Status Verified

March 1, 2023

Enrollment Period

10 months

First QC Date

February 6, 2023

Last Update Submit

March 24, 2023

Conditions

Osteosarcoma

Keywords

ESWTCell proliferationCell viability

Outcome Measures

Primary Outcomes (2)

  • Scratch assay

    cell migration

    72hours

  • MTT Assay and ATP analysis

    Cell viability

    74hrs

Study Arms (2)

Shockwave treated group

EXPERIMENTAL

The osteoblast like cells are treated with shockwaves

Device: Extracorporeal shockwave device

No shockwave group

PLACEBO COMPARATOR

The osteoblast like cells are not exposed to shockwaves

Device: No ESWT

Interventions

Extracorporeal shockwave deviceDEVICE

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
Shockwave treated group
No ESWTDEVICE

the osteoblast like cells are not exposed to shockwaves

Also known as: shockwave
No shockwave group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Contaminated cell cultures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Roxanne

Bengaluru, Karnataka, 562157, India

Location

MeSH Terms

Conditions

OsteosarcomaHyperplasia

Condition Hierarchy (Ancestors)

Neoplasms, Bone TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsSarcomaPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: test group - application of shockwave on osteoblast control group - No shockwave on osteoblast
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

February 6, 2023

First Posted

April 6, 2023

Study Start

October 22, 2021

Primary Completion

August 17, 2022

Study Completion

November 6, 2022

Last Updated

April 6, 2023

Record last verified: 2023-03

Locations

IN(1)