Periodontal Attachment LossESWTNCT05766293
ESWT on Human Gingival Fibroblasts
A study testing extracorporeal shockwave device and Fibroblast cell lines not subjected to shockwaves from extracorporeal shockwave device in people with Periodontal Attachment Loss, run by Dr Prabhuji MLV at 1 site in India.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Periodontal Attachment Loss
- What is being tested?
- extracorporeal shockwave device and Fibroblast cell lines not subjected to shockwaves from extracorporeal shockwave device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteIndia
- Study dates
- 22 Aug 2022to 10 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Viable human gingival fibroblast
- Healthy gingival tissue
Who cannot join
- contaminated samples
Trial locations and contacts
1 site in 1 country.
India1 site
Krishnadevaraya College of Dental Science and Hospital
Bengaluru, Karnataka, 562157
About this study
Official title: Application of Extracorporeal Shockwaves on Human Gingival Fibroblasts in Vitro Study
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
Read the 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.
- Conditions
- Periodontal Attachment Loss
- Being tested
- extracorporeal shockwave device, Fibroblast cell lines not subjected to shockwaves from extracorporeal shockwave device
- Keywords
- Cell culture, ESWT, Cell proliferation, Cell viability
- Medical subject headings
- Periodontal Attachment Loss, Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
extracorporeal shockwave deviceDevice
Fibroblast cell lines (n=10) were subjected to Shockwaves from extracorporeal shockwave device
Fibroblast cell lines not subjected to shockwaves from extracorporeal shockwave deviceOther
Fibroblast cell lines (n=10) without shockwave exposure
| Study group | Role | What they receive |
|---|---|---|
| Shockwave treated group | Active comparator | Effect of Extracorporeal shockwaves on Fibroblast cell proliferation and cell viability Receives: Device: extracorporeal shockwave device |
| No shockwave group | Placebo comparator | Fibroblast cell lines assessed for proliferative rate and viability without shockwave exposure. Receives: Other: Fibroblast cell lines not subjected to shockwaves from extracorporeal shockwave device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibroblast cell lines exposed to shockwave from extracorporeal shockwave device
Cell proliferation and Cell viability
Measured: 74 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start22 Aug 2022
- Primary completion17 Nov 2022
- Study completion10 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal Attachment LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Prabhuji MLV
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr Prabhuji MLV, Krishnadevaraya College of Dental Sciences & Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05766293
- Sponsor's protocol ID
- KCDS/48
- Acronym
- ESWT
- Status last verified
- Mar 2023
- First submitted
- 14 Feb 2023
- Last updated
- 13 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Extracorporeal Shockwaves on Human Gingival Fibroblasts in Vitro Study
- ClinicalTrials.gov ID
- NCT05766293
- Acronym / sponsor ID
- ESWT / KCDS/48
- Conditions
- Periodontal Attachment Loss
- Keywords
- Cell culture, ESWT, Cell proliferation, Cell viability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Dr Prabhuji MLVUniversity, hospital or other
- Study start
- 22 Aug 2022 (actual)
- Primary completion
- 17 Nov 2022 (actual)
- Study completion
- 10 Jan 2023 (actual)
- First posted
- 13 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Shockwave treated group | Active comparator | Device: extracorporeal shockwave deviceEffect of Extracorporeal shockwaves on Fibroblast cell proliferation and cell viability |
| No shockwave group | Placebo comparator | Other: Fibroblast cell lines not subjected to shockwaves from extracorporeal shockwave deviceFibroblast cell lines assessed for proliferative rate and viability without shockwave exposure. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Viable human gingival fibroblast
- Healthy gingival tissue
Key exclusion criteria (1 listed)
- contaminated samples
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| extracorporeal shockwave deviceFibroblast cell lines (n=10) were subjected to Shockwaves from extracorporeal shockwave device | Device | Shockwave treated group |
| Fibroblast cell lines not subjected to shockwaves from extracorporeal shockwave deviceFibroblast cell lines (n=10) without shockwave exposure | Other | No shockwave group |
Primary outcome
Fibroblast cell lines exposed to shockwave from extracorporeal shockwave device
Time frame: 74 hrs
Cell proliferation and Cell viability
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing extracorporeal shockwave device and Fibroblast cell lines not subjected to shockwaves from extracorporeal shockwave device in people with Periodontal Attachment Loss, run by Dr Prabhuji MLV at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fibroblast cell lines exposed to shockwave from extracorporeal shockwave device (time frame: 74 hrs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2023.