Gingival RecessionNCT03570333
Progenitor Potential of Mesenchymal Stem Cells in Palatal Tissue Harvested From Molar and Premolar Sites
A study testing progenitor potential of Gingival Mesenchymal cells in people with Gingival Recession and Lack of Keratinized Gingiva (Disorder), run by University of Alabama at Birmingham at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession, Lack of Keratinized Gingiva (Disorder)
- What is being tested?
- progenitor potential of Gingival Mesenchymal cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Sep 2018to 6 Dec 2025
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- Ability of the participants to maintain good oral hygiene
- Patient not pregnant or breastfeeding
- Not taking medications known to cause gingival enlargement
Who cannot join
- 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.
Show all 9Show fewer
- Poor oral hygiene
- Patient pregnant or breastfeeding
- Taking medications known to cause gingival enlargement
Trial locations and contacts
1 site in 1 country.
United States1 site
UAB School of Dentistry Department of Periodontology
Birmingham, Alabama, 35294-0007
About this study
Official title: Identification and Application of Gingival Mesenchymal Stem Cells for Dental Tissue Regeneration.
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.
Read the 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.
- Being tested
- progenitor potential of Gingival Mesenchymal cells
- Keywords
- gingival recession, gingival graft, Palate, Gingival mesenchymal stem cells, molar, premolar
- Medical subject headings
- Gingival Recession, Bicuspid Aortic Valve Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
progenitor potential of Gingival Mesenchymal cellsDiagnostic test
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 group | Role | What they receive |
|---|---|---|
| Progenitor Potential at Molar site | Experimental | 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. Receives: Diagnostic Test: progenitor potential of Gingival Mesenchymal cells |
| Progenitor Potential at Premolar site | Experimental | 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. Receives: Diagnostic Test: progenitor potential of Gingival Mesenchymal cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Osteogenic potential
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
Measured: At day 1 Visit 1
Secondary outcomes (2)
Adipogenic potential
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.
Measured: At day 1 Visit 1
Genotype assay
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.
Measured: At day 1 Visit 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start17 Sep 2018
- Primary completion30 Dec 2019
- Study completion6 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival RecessionStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maninder Kaur, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03570333
- Sponsor's protocol ID
- IRB-300000607
- Other IDs
- UAB-Perio
- Status last verified
- Dec 2025
- First submitted
- 17 Jun 2018
- Last updated
- 19 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification and Application of Gingival Mesenchymal Stem Cells for Dental Tissue Regeneration.
- ClinicalTrials.gov ID
- NCT03570333
- Acronym / sponsor ID
- IRB-300000607
- Keywords
- gingival recession, gingival graft, Palate, Gingival mesenchymal stem cells, molar, premolar
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 17 Sep 2018 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 6 Dec 2025 (actual)
- First posted
- 26 Jun 2018 (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 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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Progenitor Potential at Molar site | Experimental | Diagnostic Test: progenitor potential of Gingival Mesenchymal cellsHarvested 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. |
| Progenitor Potential at Premolar site | Experimental | Diagnostic Test: progenitor potential of Gingival Mesenchymal cellsHarvested 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
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 |
|---|---|---|
| progenitor potential of Gingival Mesenchymal cellstissues 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. | Diagnostic test | Progenitor Potential at Molar site, Progenitor Potential at Premolar site |
Primary outcome
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
2 secondary outcomes
Adipogenic potential
Time frame: At day 1 Visit 1
Genotype assay
Time frame: At day 1 Visit 1
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 19 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Gingival Recession
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i-PRF-Based Bioactive Matrix vs. Connective Tissue Graft in the Treatment of Gingival Recessions
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Palatal Wound Healing After Free Gingival Graft Harvest in Diabetic Patients: A Clinical Trial
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Evaluation of the Effect of Smoking on Palatal Donor Site Tissue Profile in the Success of Connective Tissue Grafts
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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 progenitor potential of Gingival Mesenchymal cells in people with Gingival Recession and Lack of Keratinized Gingiva (Disorder), run by University of Alabama at Birmingham at 1 site in United States.
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 9 inclusion and 9 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 19 Dec 2025. 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 United States. 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. 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?
Osteogenic potential (time frame: At day 1 Visit 1). 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 19 Dec 2025.