ESWT on Human Gingival Fibroblasts (ESWT)
Primary Purpose
Periodontal Attachment Loss
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
extracorporeal shockwave device
Fibroblast cell lines not subjected to shockwaves from extracorporeal shockwave device
Sponsored by
About this trial
This is an interventional health services research trial for Periodontal Attachment Loss focused on measuring Cell culture, ESWT, Cell proliferation, Cell viability
Eligibility Criteria
Inclusion Criteria: Viable human gingival fibroblast Healthy gingival tissue Exclusion Criteria: contaminated samples
Sites / Locations
- Krishnadevaraya College of Dental Science and Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Shockwave treated group
No shockwave group
Arm Description
Effect of Extracorporeal shockwaves on Fibroblast cell proliferation and cell viability
Fibroblast cell lines assessed for proliferative rate and viability without shockwave exposure.
Outcomes
Primary Outcome Measures
Fibroblast cell lines exposed to shockwave from extracorporeal shockwave device
Cell proliferation and Cell viability
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05766293
Brief Title
ESWT on Human Gingival Fibroblasts
Acronym
ESWT
Official Title
Application of Extracorporeal Shockwaves on Human Gingival Fibroblasts in Vitro Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
August 22, 2022 (Actual)
Primary Completion Date
November 17, 2022 (Actual)
Study Completion Date
January 10, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr Prabhuji MLV
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Attachment Loss
Keywords
Cell culture, ESWT, Cell proliferation, Cell viability
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Shockwave treated group
Arm Type
Active Comparator
Arm Description
Effect of Extracorporeal shockwaves on Fibroblast cell proliferation and cell viability
Arm Title
No shockwave group
Arm Type
Placebo Comparator
Arm Description
Fibroblast cell lines assessed for proliferative rate and viability without shockwave exposure.
Intervention Type
Device
Intervention Name(s)
extracorporeal shockwave device
Intervention Description
Fibroblast cell lines (n=10) were subjected to Shockwaves from extracorporeal shockwave device
Intervention Type
Other
Intervention Name(s)
Fibroblast cell lines not subjected to shockwaves from extracorporeal shockwave device
Intervention Description
Fibroblast cell lines (n=10) without shockwave exposure
Primary Outcome Measure Information:
Title
Fibroblast cell lines exposed to shockwave from extracorporeal shockwave device
Description
Cell proliferation and Cell viability
Time Frame
74 hrs
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Viable human gingival fibroblast
Healthy gingival tissue
Exclusion Criteria:
contaminated samples
Facility Information:
Facility Name
Krishnadevaraya College of Dental Science and Hospital
City
Bengaluru
State/Province
Karnataka
ZIP/Postal Code
562157
Country
India
12. IPD Sharing Statement
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ESWT on Human Gingival Fibroblasts
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