What side effects are associated with this type of intervention?

Common treatments for gum recession include surgical procedures like gum grafting, non-surgical treatments such as scaling and root planing, and regenerative therapies like mesenchymal stem cell (MSC) therapy. Surgical treatments can lead to side effects such as pain, swelling, infection, and graft rejection. Non-surgical treatments may cause temporary discomfort and sensitivity. MSC therapies, while promising in regenerative potential, are still under investigation, and potential side effects could include immune reactions, infection, and unintended tissue growth. Overall, MSC therapies are considered experimental, and their long-term safety profile is not yet fully established.

What prior FDA approvals exist?

Currently, there are no specific FDA-approved treatments for gum recession that utilize mesenchymal stem cells (MSCs) or similar regenerative therapies. Traditional treatments for gum recession typically involve surgical procedures such as connective tissue grafts, laterally positioned flaps, or tunneling techniques. These methods aim to cover exposed roots and regenerate gum tissue but do not specifically involve MSCs. Research is ongoing to explore the potential of MSCs in periodontal regeneration, but these therapies have not yet received FDA approval.

What other types of research exist?

Promising novel alternatives to Mesenchymal Stem Cells for treating gum recession in 2024 include: 1) Platelet-Rich Fibrin (PRF), which promotes healing and tissue regeneration; 2) Hyaluronic Acid (HA) fillers, known for their ability to enhance soft tissue volume and support; and 3) Low-Level Laser Therapy (LLLT), which has shown potential in improving healing and reducing inflammation in periodontal tissues.

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Stem Cell Regeneration for Gum Recession

Q: What is the mechanism of action of this treatment?

Common treatments for gum recession include connective tissue grafts, laterally positioned flaps, and tunneling techniques. These methods primarily work by covering the exposed root surfaces and promoting the regeneration of gum tissue. Connective tissue grafts involve taking tissue from another part of the mouth and attaching it to the affected area, which helps in thickening the gum and covering the recession. Laterally positioned flaps and tunneling techniques involve repositioning existing gum tissue to cover the exposed roots. The use of mesenchymal stem cells (MSCs) in these treatments is being studied for their regenerative and differentiation potential, which could enhance tissue repair and regeneration. This matters for patients as MSCs could potentially offer more effective and long-lasting solutions for gum tissue regeneration, reducing the need for more invasive procedures.

N/A

Waitlist Available

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Presence of periodontally healthy teeth at the recipient site

No previous harvesting procedure involving the palate

Must not have

Presence of periodontal disease at the recipient site

Patients that have severe gingival recession (Miller class III and IV) or < 2 mm

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at day 1 visit 1

Awards & highlights

No Placebo-Only Group

Summary

This trial uses special cells from the gums that can turn into different types of tissues. It targets patients undergoing gum grafting surgery. These cells help repair and regenerate damaged tissues by transforming into the needed cell types.

Who is the study for?

This trial is for English-speaking patients at the UAB Dental School with healthy teeth and gums who need a soft tissue graft due to mild to moderate gum recession. They must be able to maintain good oral hygiene, not be pregnant or breastfeeding, and not have had previous palate surgery.

What is being tested?

The study aims to compare the regenerative abilities of mesenchymal stem cells taken from two areas in the mouth's roof (palate) - near the front (premolar) and back (molar). It will help optimize how these cells are used in repairing tissues like bone and gums.

What are the potential side effects?

Since this trial involves harvesting cells rather than drug treatment, side effects may include discomfort or pain at the extraction site, bleeding, infection risk, swelling, and possible complications related to wound healing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My gums and teeth are healthy where I need treatment.

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I have never had tissue taken from the roof of my mouth.

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I need a gum graft for my teeth with mild to moderate recession.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have gum disease where I will receive treatment.

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I have severe gum recession.

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I am taking medication that can cause gum swelling.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at day 1 visit 1

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at day 1 visit 1

This trial's timeline: 3 weeks for screening, Varies for treatment, and at day 1 visit 1 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Osteogenic potential

Secondary study objectives

Adipogenic potential

Genotype assay

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Progenitor Potential at Premolar siteExperimental Treatment1 Intervention

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.

Group II: Progenitor Potential at Molar siteExperimental Treatment1 Intervention

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.

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for gum recession include connective tissue grafts, laterally positioned flaps, and tunneling techniques. These methods primarily work by covering the exposed root surfaces and promoting the regeneration of gum tissue. Connective tissue grafts involve taking tissue from another part of the mouth and attaching it to the affected area, which helps in thickening the gum and covering the recession. Laterally positioned flaps and tunneling techniques involve repositioning existing gum tissue to cover the exposed roots. The use of mesenchymal stem cells (MSCs) in these treatments is being studied for their regenerative and differentiation potential, which could enhance tissue repair and regeneration. This matters for patients as MSCs could potentially offer more effective and long-lasting solutions for gum tissue regeneration, reducing the need for more invasive procedures.

Root Coverage Predictability in the Treatment of Gingival Recessions on Mandibular Anterior Teeth.