ESWT on Human Gingival Fibroblasts

NCT ID: NCT05766293

Last Updated: 2023-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-22

Study Completion Date

2023-01-10

Brief Summary

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The idea of treating different deformities or diseases in the maxillofacial region with Extracorporeal Shockwave Therapy (ESWT) has recently become popular. Shockwave therapy was first introduced in Germany in 1980s and has been widely used in medical practice for the management of urolithiasis, cholelithiasis and in head and neck region for sialolithiasis.

The present study 'Application of Extracorporeal Shock Wave Therapy on human gingival derived fibroblasts In-vitro study' was done to explore and evaluate the effect of shockwaves. Further, these cells were assessed for Cell - Cell interaction and Cell Viability.

In this in-vitro study, 20 fibroblast cells were included. 10 samples were considered for Control group and the remaining 10 samples were considered as Test group. Extracorporeal shockwave was applied to the Test samples. They were further analysed

Detailed Description

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BACKGROUND:

Improved understanding of human biology at the molecular level, scientific and technologic advances are emerging aspects in dentistry. The idea of treating different deformities or diseases in the maxillofacial region with Extracorporeal Shockwave Therapy (ESWT) has recently become popular. Shockwave therapy was first introduced in Germany in 1980s and has been widely used in medical practice for the management of urolithiasis, cholelithiasis and in head and neck region for sialolithiasis.

AIM:

The present study 'Application of Extracorporeal Shock Wave Therapy on human gingival tissue derived fibroblasts In-vitro study' was done to explore and evaluate the effect of shockwaves. Further, fibroblast cells were assessed for Cell - Cell interaction and Cell Viability.

MATERIALS AND METHODS:

In this in-vitro study, 20 fibroblast cells were included. 10 samples were considered for Control group and the remaining 10 samples were considered as Test group. Extracorporeal shockwave was applied to the Test samples. They were further analysed using wound scratch assay which was used to assess Cell proliferative rate and scratch closure through live imaging. MTT assay and ATP assay was used to determine Cell viability after exposure to shockwaves.

Conditions

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Periodontal Attachment Loss

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

PCS-201-018 Fibroblast cell line (n=10) would be exposed to shockwave generator depending on Test group. Control group Fibroblast cell line (n=10) would be assessed without shockwave exposure. Cell proliferation and Cell viability will be assessed for both Test and Control Fibroblast cell lines using Scratch assay, MTT analysis and ATP analysis, accordingly.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Shockwave treated group

Effect of Extracorporeal shockwaves on Fibroblast cell proliferation and cell viability

Group Type ACTIVE_COMPARATOR

extracorporeal shockwave device

Intervention Type DEVICE

Fibroblast cell lines (n=10) were subjected to Shockwaves from extracorporeal shockwave device

No shockwave group

Fibroblast cell lines assessed for proliferative rate and viability without shockwave exposure.

Group Type PLACEBO_COMPARATOR

Fibroblast cell lines not subjected to shockwaves from extracorporeal shockwave device

Intervention Type OTHER

Fibroblast cell lines (n=10) without shockwave exposure

Interventions

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extracorporeal shockwave device

Fibroblast cell lines (n=10) were subjected to Shockwaves from extracorporeal shockwave device

Intervention Type DEVICE

Fibroblast cell lines not subjected to shockwaves from extracorporeal shockwave device

Fibroblast cell lines (n=10) without shockwave exposure

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Viable human gingival fibroblast
* Healthy gingival tissue

Exclusion Criteria

* contaminated samples
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dr Prabhuji MLV

OTHER

Sponsor Role lead

Responsible Party

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Dr Prabhuji MLV

Professor, Head of Periodontology, Principle investigator, Clinical Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Krishnadevaraya College of Dental Science and Hospital

Bengaluru, Karnataka, India

Site Status

Countries

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India

Other Identifiers

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KCDS/48

Identifier Type: -

Identifier Source: org_study_id

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