What is the mechanism of action of this treatment?

The most common treatments for palate wounds, such as the Amnio-Chorion Membrane (ACM), work by promoting healing and reducing inflammation. ACM contains growth factors and anti-inflammatory cytokines that accelerate tissue regeneration and minimize inflammatory responses. This is crucial for palate wound patients as it leads to faster recovery, reduced pain, and lower risk of infection. Other treatments, like hemostatic agents, primarily focus on controlling bleeding and providing a scaffold for new tissue growth, further aiding in the healing process.

What side effects are associated with this type of intervention?

Treatments for palate wounds that utilize biological membranes like the amnio-chorion membrane (ACM) and lyophilized homograft amniotic membrane are generally aimed at promoting healing and reducing inflammation. These treatments have shown promising results in facilitating wound healing and inducing epithelialization. Common side effects may include mild local reactions such as irritation or discomfort at the application site. In some cases, there may be a risk of infection or hypersensitivity reactions, although these are typically rare and resolve with treatment withdrawal.

What prior FDA approvals exist?

There is no specific mention of prior FDA approvals for treatments specifically targeting palate wounds in the provided context. However, treatments that promote healing and reduce inflammation, such as the amnio-chorion membrane (ACM), are being studied for their potential benefits. ACM is known for its biological properties that aid in wound healing and inflammation reduction. Similar treatments in other contexts include the use of amniotic membranes in various wound healing applications, which have shown promise in facilitating epithelialization and reducing healing time.

What other types of research exist?

Promising alternatives to Amnio-Chorion Membrane for palate wound healing include Platelet-Rich Fibrin (PRF) and Hyaluronic Acid (HA) gels. PRF promotes healing through the release of growth factors and cytokines, while HA gels aid in tissue regeneration and hydration, reducing inflammation and promoting faster healing.

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Amnion-Chorion Membrane for Palate Wound Healing

N/A

Recruiting

Led By Brian Mealey, DDS, MS

Research Sponsored by The University of Texas Health Science Center at San Antonio

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 24, 48 and 72 hours post-surgery

Summary

This trial is testing if a special tissue bandage helps mouth surgery wounds heal better and reduces pain compared to a common gauze. The study focuses on patients who need healing in the roof of their mouth after surgery. The special tissue bandage has been used in various oral surgeries for tissue regeneration.

Who is the study for?

This trial is for adults aged 18-89 needing gum surgery in the mouth area from back molar to back molar, whether they have teeth, implants, or none. Participants can be non-smokers or light smokers (less than 10 cigarettes a day), including women who are not pregnant and either post-menopausal, had tubal ligation/hysterectomy, or use contraception. They must also be able to follow up and own a smartphone.

What is being tested?

The study compares two methods of healing after gum surgery: using an amnion-chorion membrane (ACM) versus ActCel Cellulose Gauze—a common bleeding control product. It aims to see if there's a difference in how the palate heals and how much pain patients feel with each treatment.

What are the potential side effects?

While specific side effects aren't listed here, typical risks may include discomfort at the wound site, potential infection risk due to open wounds in the mouth area, allergic reactions to materials used like ACM or gauze, and general complications related to oral surgeries.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24, 48 and 72 hours post-surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24, 48 and 72 hours post-surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24, 48 and 72 hours post-surgery for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Post-operative pain

Wound healing time

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Use Amnio Chorion Membrane (ACM) with hemostatic agentActive Control2 Interventions

ACM or amnion-only membranes have been used in oral surgical procedures primarily because they contain a host of growth factors that play a role in normal wound healing.

Group II: Use of ActCel Cellulose Gauze (Commercial Hemostatic Agent)Placebo Group1 Intervention

Palatal wound dressing with hemostatic agent

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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 most common treatments for palate wounds, such as the Amnio-Chorion Membrane (ACM), work by promoting healing and reducing inflammation. ACM contains growth factors and anti-inflammatory cytokines that accelerate tissue regeneration and minimize inflammatory responses. This is crucial for palate wound patients as it leads to faster recovery, reduced pain, and lower risk of infection. Other treatments, like hemostatic agents, primarily focus on controlling bleeding and providing a scaffold for new tissue growth, further aiding in the healing process.

The effects of lyophilized homograft amniotic membrane on wound healing on rabbits.