- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03570333
Progenitor Potential of Mesenchymal Stem Cells in Palatal Tissue Harvested From Molar and Premolar Sites
Identification and Application of Gingival Mesenchymal Stem Cells for Dental Tissue Regeneration.
Study Overview
Status
Intervention / Treatment
Detailed Description
Various types of stem cells, specifically Mesenchymal Stem Cells (MSCs) have been thoroughly investigated for their role in tissue engineering, regenerative medicine and regeneration of the attachment apparatus (bone, cementum, periodontal ligament) of the tooth (that is lost due to periodontal disease) through multidisciplinary integration of research and clinical practice.
Recently population of progenitor/stromal cells have been isolated form gingival connective tissue that shows stem cell nature and is known as Gingival Mesenchymal Stem Cells (GMSCs). GMSCs have shown to have higher rate of successive culture and proliferation compared to other sources of stem cells, and have demonstrated multi-lineage differentiation in osteoblastic, adipocytic, chondrocytic, endothelial and neural directions, however most of our present understanding and elucidation models stem from in vitro cell culture and in vivo animal models, which do not entirely translate to human clinical situations. To bridge our current knowledge gaps of tissue development processes, deeper understanding of biological processes is required, before reliable biologically based regenerative therapies become a clinical reality. Palatal gingival connective tissue, which can be a great source of GMSCs, is harvested primarily for treating gingival recession around teeth or dental implants. There is very little studied on the histological, cellular make up and the soft and hard tissue regenerative potential of this tissue owing to the presence of GMSCs. Also, the clinical decision as to where to harvest the tissue from relies on the amount of available tissue, indication of the treatment, and the clinical preference of the operator rather than based on progenitor potential and regenerative capabilities of the underlying cells.
Hence aim of this study is to investigate the progenitor potential of palatal GMSCs as well as characterizing and observing the functionality of isolated MSCs at two different palatal sites within the same patient.
The study will retrieve human soft tissue (gum tissue) samples from the roof of the mouth (palate) that are collected during soft tissue (gum) grafting surgical procedures routinely performed and are standard of care for treating gum recession in the School of Dentistry's Periodontology Clinic. For research purposes an additional 4mm of soft tissue samples will be obtained from two sites that is 2mm from front site (premolar) and 2mm from back site (molar) from the roof of the mouth (palate). The samples will be placed in sterile vials in the carrier medium and will be immediately transferred to the laboratory for the analysis. The remaining soft tissue (gum) graft will be used to cover the gum recession defects in that patient's mouth. A plastic guard will be placed on the roof of the mouth (palate) after the procedure to reduce post-op discomfort.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35294-0007
- UAB School of Dentistry Department of Periodontology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- English speaking
- Must be a patient of the UAB Dental School
- Able to read and understand informed consent document
- Patients needing soft tissue graft with teeth that have miller class I or II recession (>=2mm) on the facial aspects
- No previous harvesting procedure involving the palate
- Presence of periodontally healthy teeth at the recipient site.
- Ability of the participants to maintain good oral hygiene
- Patient not pregnant or breastfeeding
- Not taking medications known to cause gingival enlargement
Exclusion Criteria:
- Non-English speaking
- Smokers/tobacco users
- Patients with systemic pathologies or conditions contraindicating oral surgical procedures or adversely affecting wound healing
- Patients that have severe gingival recession (Miller class III and IV) or < 2 mm.
- Previous harvesting procedure involving the palate (within 1 year)
- Presence of periodontal disease at the recipient site.
- Poor oral hygiene
- Patient pregnant or breastfeeding
- Taking medications known to cause gingival enlargement
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Progenitor Potential at Molar site
Harvested tissue from the back (molar) part of the palate will be used to extract the gingival mesenchymal cells to test their progenitor potential to differentiate into multiple cell lineage.
|
tissues collected from the molar and premolar sites will be sent to the lab for cell culturing.
once in the lab, the tissues will be already separated and labeled (molar) and ( premolar) and then treated to extract the cells from them.
then, these cells will be tested for their capacity to form different kinds of cells and tissues ( bone, cartilage, fibers for periodontal ligaments).
After this test, results will be collected for how many cells were collected from each tissue sample.
|
Experimental: Progenitor Potential at Premolar site
Harvested tissue from the front (premolar) part of the palate will be used to extract the gingival mesenchymal cells to test their progenitor potential to differentiate into multiple cell lineage.
|
tissues collected from the molar and premolar sites will be sent to the lab for cell culturing.
once in the lab, the tissues will be already separated and labeled (molar) and ( premolar) and then treated to extract the cells from them.
then, these cells will be tested for their capacity to form different kinds of cells and tissues ( bone, cartilage, fibers for periodontal ligaments).
After this test, results will be collected for how many cells were collected from each tissue sample.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Osteogenic potential
Time Frame: At day 1 Visit 1
|
To assess mineralization (osteogenic) potential of mesenchymal stem cells isolated from premolar and molar site, double staining with alcian blue and von Kossa will be performed
|
At day 1 Visit 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adipogenic potential
Time Frame: At day 1 Visit 1
|
To assess the adipogenic potential of mesenchymal stem cells isolated from premolar and molar site, cells will be stained with oil red o stain and the stained fat droplets will be visualized by light microscopy and photographed.
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At day 1 Visit 1
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Genotype assay
Time Frame: At day 1 Visit 1
|
RNA (ribonucleic acid) isolation and reverse transcriptase PCR (polymerase chain reaction) analysis will be performed to test the genetic make up of the mesenchymal stem cells isolated from premolar and molar site.
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At day 1 Visit 1
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GMC:18
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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