ESWT on Human Gingival Fibroblasts | NCT05766293

Studies
ESWT on Human Gingival Fibroblasts

NCT05766293

Sponsor

Dr Prabhuji MLV

Status

Completed

Last Update Posted

Mar 13, 2023Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Periodontal Attachment Loss

Interventions

extracorporeal shockwave device
Fibroblast cell lines not subjected to shockwaves from extracorporeal shockwave device

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 22, 2022Actual

Primary Completion Date

Nov 17, 2022Actual

Completion Date

Jan 10, 2023Actual

First Submitted Date

Feb 14, 2023

First Submission Date that Met QC Criteria

Mar 2, 2023

First Posted Date

Mar 13, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 2, 2023

Last Update Posted Date

Mar 13, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr Prabhuji MLV, Professor, Head of Periodontology, Principle investigator, Clinical Professor, Krishnadevaraya College of Dental Sciences & HospitalSponsor-Investigator

Lead Sponsor

Dr Prabhuji MLVOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Shockwave treated group	Active Comparator	Effect of Extracorporeal shockwaves on Fibroblast cell proliferation and cell viability	Device: extracorporeal shockwave device
No shockwave group	Placebo Comparator	Fibroblast cell lines assessed for proliferative rate and viability without shockwave exposure.	Other: Fibroblast cell lines not subjected to shockwaves from extracorporeal shockwave device

Interventions

Name	Type	Description	Arm Group Labels	Other Names
extracorporeal shockwave device	Device	Fibroblast cell lines (n=10) were subjected to Shockwaves from extracorporeal shockwave device	Shockwave treated group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Fibroblast cell lines exposed to shockwave from extracorporeal shockwave device	Cell proliferation and Cell viability	74 hrs

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Viable human gingival fibroblast
Healthy gingival tissue

Exclusion Criteria:

contaminated samples

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Krishnadevaraya College of Dental Science and Hospital		Bengaluru	Karnataka	562157	India

Condition Browse Module

MeSH Terms

ID	Term
D017622	Periodontal Attachment Loss
D006965	Hyperplasia

Ancestor Terms

ID	Term
D055093	Periodontal Atrophy
D010510	Periodontal Diseases
D009059	Mouth Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Model Description

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.