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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

Awards & highlights

Study Summary

This trial tests if a different dressing helps healing & pain relief after surgery in the mouth area.

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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center at San AntonioLead Sponsor

453 Previous Clinical Trials

91,356 Total Patients Enrolled

Brian Mealey, DDS, MSPrincipal InvestigatorUniversity of Texas Health Science Center San Antonio

1 Previous Clinical Trials

120 Total Patients Enrolled

Media Library

Use Amnio Chorion Membrane (ACM) with hemostatic agent Clinical Trial Eligibility Overview. Trial Name: NCT05927714 — N/A

Palate Wound Research Study Groups: Use Amnio Chorion Membrane (ACM) with hemostatic agent, Use of ActCel Cellulose Gauze (Commercial Hemostatic Agent)

Palate Wound Clinical Trial 2023: Use Amnio Chorion Membrane (ACM) with hemostatic agent Highlights & Side Effects. Trial Name: NCT05927714 — N/A

Use Amnio Chorion Membrane (ACM) with hemostatic agent 2023 Treatment Timeline for Medical Study. Trial Name: NCT05927714 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical trial extend to adults above the age of majority?

"The minimum age requirement to take part in this trial is 18 and the maximum allowed age is 89."

Answered by AI

Who is best suited for involvement in this trial?

"Patients with palate wounds aged between 18-89 are encouraged to partake in this clinical trial, which is looking for a total of 74 individuals."

Answered by AI

Could you please provide an update regarding the current eligibility for participation in this research?

"As displayed on clinicaltrials.gov, this medical trial is not currently enrolling patients; however, it was original posted on August 1st 2023 and most recently modified June 29th of the same year. Fortunately there are 781 other trials actively recruiting candidates at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Palatal Donor Site Wound Healing Following Periodontal Plastic Surgery Using Amnion-Chorion Membrane

Brian L Mealey 2023. "Palatal Donor Site Wound Healing Following Periodontal Plastic Surgery Using Amnion-Chorion Membrane". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05927714.