What is the mechanism of action of this treatment?

The treatment of gum recession often involves procedures that aim to regenerate lost gum tissue and improve attachment to the teeth. The Allogenic Dermal Matrix serves as a scaffold that supports tissue regeneration, while Platelet-Rich Fibrin (PRF) releases growth factors that promote healing and tissue growth. This combination enhances the body's natural healing processes, leading to better outcomes in terms of tissue regeneration and stability. For patients, these treatments are crucial as they not only improve the aesthetic appearance of the gums but also restore the protective function of the gum tissue, reducing sensitivity and the risk of further recession.

What side effects are associated with this type of intervention?

Common treatments for gum recession, such as those involving Allogenic Dermal Matrix with Platelet-Rich Fibrin, generally have side effects including postoperative pain, swelling, and potential infection at the graft site. There is also a risk of graft rejection or complications with graft integration, and patients may experience temporary sensitivity in the treated area.

What prior FDA approvals exist?

The FDA has approved various treatments for gum recession, including the use of connective tissue grafts and other regenerative techniques. Treatments similar to the Allogenic Dermal Matrix with Platelet-Rich Fibrin, which utilize scaffolds for tissue regeneration and growth factor release, are part of ongoing research. While specific FDA approvals for this exact combination are not detailed, the use of platelet-rich fibrin and dermal matrices in periodontal therapy is supported by clinical studies aiming to enhance tissue regeneration and healing.

What other types of research exist?

Promising novel alternatives for gum recession treatment in 2024 include the use of autologous platelet concentrates (APC) such as platelet-rich plasma (PRP) and platelet-rich fibrin (PRF), which have shown potential in enhancing healing and tissue regeneration. Additionally, the use of genetically modified autologous cultured skin grafts and gene therapy approaches, such as beremagene geperpavec (B-VEC), are emerging as innovative treatments for tissue regeneration and repair.

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Allogenic Dermal Matrix

Platelet-Rich Fibrin Treatment for Gum Recession

N/A

Waitlist Available

Led By Hom-Lay Wang, DDS MSD PhD

Research Sponsored by University of Michigan

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up changes of from baseline (prior to treatment) compared with 3 and 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if a donor skin graft with a healing substance from the patient's blood is as effective as the standard treatment for receding gums.

Who is the study for?

Adults with healthy gums and overall health, who have not had root coverage procedures in the past year. They must have good oral hygiene, low plaque and bleeding scores, and at least one gingival recession of 3 mm or deeper needing surgery. Excluded are those with loose teeth, pregnancy or nursing women, untreated infections or malignancies at the site, blood disorders, severe co-morbidities, sensitivity to certain antibiotics or undergoing treatments that affect healing.

What is being tested?

The trial is testing if using an Allogenic Dermal Matrix combined with Platelet-Rich Fibrin is as effective as the standard Connective Tissue Graft for treating gum recession. Participants will undergo a tunneled coronally advanced flap procedure where these materials are used to cover exposed roots.

What are the potential side effects?

Possible side effects may include discomfort at the surgical site, swelling, bruising, infection risk increase due to surgery itself. Specific reactions to Platelet-Rich Fibrin or Allogenic Dermal Matrix could occur but are generally rare.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ changes of from baseline (prior to treatment) compared with 3 and 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~changes of from baseline (prior to treatment) compared with 3 and 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and changes of from baseline (prior to treatment) compared with 3 and 6 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Complete root coverage (CRC)

Duration of surgical procedure

Gingival thickness (GT) gain

+3 more

Secondary study objectives

Patient-reported esthetics

Patient-reported post-operative pain as measured with a mobile application

Patient-reported satisfaction

+3 more

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

Active Control

Group I: Allogenic Dermal Matrix with Platelet-Rich FibrinExperimental Treatment1 Intervention

An allogenic dermal matrix with the patient's platelet-rich fibrin will be used

Group II: Connective Tissue GraftActive Control1 Intervention

A connective tissue graft from the patient's palate will be used

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tunneled coronally advanced flap

2023

N/A

~40

Do I qualify?Apply below to find out

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

The treatment of gum recession often involves procedures that aim to regenerate lost gum tissue and improve attachment to the teeth. The Allogenic Dermal Matrix serves as a scaffold that supports tissue regeneration, while Platelet-Rich Fibrin (PRF) releases growth factors that promote healing and tissue growth. This combination enhances the body's natural healing processes, leading to better outcomes in terms of tissue regeneration and stability. For patients, these treatments are crucial as they not only improve the aesthetic appearance of the gums but also restore the protective function of the gum tissue, reducing sensitivity and the risk of further recession.

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