ESWT on Human Gingival Fibroblasts

NCT05766293 | Completed

• 1 other identifier: KCDS/48
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Periodontal Attachment Loss

Keywords

Cell culture; ESWT; Cell proliferation; Cell viability

Outcome Measures

Primary Outcomes (1)

• Fibroblast cell lines exposed to shockwave from extracorporeal shockwave device

  Cell proliferation and Cell viability

  74 hrs

Study Arms (2)

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

extracorporeal shockwave device DEVICE

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

Shockwave treated group

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

Fibroblast cell lines (n=10) without shockwave exposure

No shockwave group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Viable human gingival fibroblast
• Healthy gingival tissue

You may not qualify if:

• contaminated samples

Sponsors & Collaborators

• Dr Prabhuji MLV: lead

Study Sites (1)

Krishnadevaraya College of Dental Science and Hospital

Bengaluru, Karnataka, 562157, India

Location

MeSH Terms

Conditions

Periodontal Attachment Loss; Hyperplasia

Condition Hierarchy (Ancestors)

Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Head of Periodontology, Principle investigator, Clinical Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 14, 2023
• First Posted: March 13, 2023
• Study Start: August 22, 2022
• Primary Completion: November 17, 2022
• Study Completion: January 10, 2023
• Last Updated: March 13, 2023

Record last verified: 2023-03

Locations

IN (1)