Progenitor Potential of Mesenchymal Stem Cells in Palatal Tissue Harvested From Molar and Premolar Sites

• ClinicalTrials.gov Identifier: NCT03570333
• Recruitment Status: Active, not recruiting
• First Posted: June 26, 2018
• Last Update Posted: December 18, 2023
• Sponsor: University of Alabama at Birmingham
• Information provided by (Responsible Party): Maninder Kaur, University of Alabama at Birmingham

Tracking Information

• First Submitted Date: June 17, 2018
• First Posted Date: June 26, 2018
• Last Update Posted Date: December 18, 2023
• Actual Study Start Date: September 17, 2018
• Actual Primary Completion Date: December 30, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 25, 2018)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 25, 2018)

• 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.
• 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Progenitor Potential of Mesenchymal Stem Cells in Palatal Tissue Harvested From Molar and Premolar Sites
• Official Title: Identification and Application of Gingival Mesenchymal Stem Cells for Dental Tissue Regeneration.
• Brief Summary: The primary purpose of this protocol is to isolate, investigate and compare the regenerative and differentiation potential of mesenchymal stem cells (MSC's) in the gingival (gum) tissue harvested from two different locations from the roof of the mouth (palate), that is from the front part(premolar)and back part(molar). MSC's are known for their capacity to form different kinds of hard and soft tissue including bone, fibers for periodontal ligaments, cementum and dentin, thus this study can help in optimizing their clinical application and transplantation approaches in tissue regeneration.

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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment

Condition

• Gingival Recession
• Lack of Keratinized Gingiva (Disorder)

Intervention

Diagnostic Test: progenitor potential of Gingival Mesenchymal cells

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.

Study Arms

• 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.
  Intervention: Diagnostic Test: progenitor potential of Gingival Mesenchymal cells
• 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.
  Intervention: Diagnostic Test: progenitor potential of Gingival Mesenchymal cells

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: June 25, 2018): 10
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 30, 2024
• Actual Primary Completion Date: December 30, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03570333
• Other Study ID Numbers: GMC:18
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Maninder Kaur, University of Alabama at Birmingham
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Alabama at Birmingham
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: University of Alabama at Birmingham
• Verification Date: December 2023