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

Palatal Donor Site Wound Healing Following Periodontal Plastic Surgery Using Amnion-Chorion Membrane: Site- and Patient-Centered Outcomes

The purpose of this clinical trial is to assess if donor site healing in the palatal area and patient pain perception are similar or different when using amnio-chorion membrane (ACM) on the donor site after surgery compared to a commonly used commercial hemostatic agent (ActCel Cellulose Gauze).

Study Overview

• Status: Recruiting
• Conditions: Palate; Wound
• Intervention / Treatment: Other: Amnion-chorion Membrane; Other: ActCel Cellulose Gauze

Detailed Description

Resorbable oxidized cellulose materials are commonly used as hemostatic agents in medicine and dentistry. Surgicel and ActCel are used daily in surgical practice. When these products come in contact with blood, they convert to a gel that expands to cause direct pressure on blood vessels and control bleeding. ActCel is water-soluble and dissolves over a short time period. It can be removed easily when water, saline or hydrogen peroxide is applied.The study team will examine the effects of ACM as a wound dressing for the donor area and compare the rate of epithelialization with and without its use.

• Study Type: Interventional
• Enrollment (Estimated): 74
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Angela Palaiologou-Gallis, DDS; Phone Number: 210-567-3567; Email: palaiologoua@uthscsa.edu
• Study Contact Backup: Name: Brian Mealey, DDS, MS; Phone Number: 210-450-8736; Email: mealey@uthscsa.edu

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • University of Texas Health Science Center at San Antonio (Dental School)
      • Contact: Brian L Mealey, DDS, MS; Phone Number: 210-567-3589; Email: mealey@uthscsa.edu
      • Contact: Angela Paiologou-Gallis, DDS; Phone Number: 210-567-3567; Email: PalaiologouA@uthscsa.edu
      • Principal Investigator: Brian L Mealey, DDS, MS
      • Sub-Investigator: Angela Palaiologou-Gallis Palaiologou-Gallis, DDS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Patients between age 18 and 89
• Patients needing an FSTA in the area of the mouth from 2nd molar to 2nd molar in the maxilla or mandible at sites that have teeth or implants, or in sites that are edentulous
• Patients must be nonsmokers, former smokers, or current smokers who smoke <10 cigarettes per day, by self-report
• Female patients who have undergone a hysterectomy, tubal ligation, or menopause, and non- pregnant women of child-bearing potential.
• Must have access to Smartphone

Exclusion Criteria:

• Patients who disclose that they will not be able to cooperate with the follow-up schedule.
• Patients who are mentally incompetent, prisoners, or pregnant (as obtained via chart review or self-report)
• Pregnant women or women intending to become pregnant during study period
• Smokers who smoke > 10 cigarettes per day

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Use Amnio Chorion Membrane (ACM) with hemostatic agent; 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.	Other: Amnion-chorion Membrane; Amnio-chorion membranes specifically for palatal wound healing following free soft tissue autografts (FTSA) procedures.; Other Names: ACM; Other: ActCel Cellulose Gauze; When these products come in contact with blood, they convert to a gel that expands to cause direct pressure on blood vessels and control bleeding. ActCel is water-soluble and dissolves over a short time period. It can be removed easily when water, saline or hydrogen peroxide is applied.; Other Names: Hemostatic agent
Placebo Comparator: Use of ActCel Cellulose Gauze (Commercial Hemostatic Agent); Palatal wound dressing with hemostatic agent	Other: ActCel Cellulose Gauze; When these products come in contact with blood, they convert to a gel that expands to cause direct pressure on blood vessels and control bleeding. ActCel is water-soluble and dissolves over a short time period. It can be removed easily when water, saline or hydrogen peroxide is applied.; Other Names: Hemostatic agent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound healing time	Change in Area of wound epithelialization will be measured in mm2 at 1, 2, 3 and 4 weeks postoperatively using an Early wound healing index (EHI) index. The index assesses 5 dichotomous variables, each with a "yes" or "no" assessment. "Yes" = score of 1; "No" = score of 2. Total score can range from 5 minimum to 10 maximum. The 5 variables are: bleeding on palpation?; incomplete epithelialization?; presence of redness?; presence of swelling?; granulation tissue present?	1, 2, 3 and 4 weeks post-operatively
Post-operative pain	Change in pain will be assessed post surgery using a smart-phone application that captures the pain level in a scale of 1-10, where a lower number indicates a less pain	24, 48 and 72 hours post-surgery

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center at San Antonio
• Investigators: Principal Investigator: Brian Mealey, DDS, MS, University of Texas Health Science Center San Antonio

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2023
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: June 22, 2023
• First Submitted That Met QC Criteria: June 22, 2023
• First Posted (Actual): July 3, 2023

Study Record Updates

• Last Update Posted (Actual): September 26, 2023
• Last Update Submitted That Met QC Criteria: September 25, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Hemostatic agent; Periodontal plastic surgery; Amnion-chorion membrane; Accelerated wound healing
• Additional Relevant MeSH Terms: Wounds and Injuries; Coagulants; Hemostatics
• Other Study ID Numbers: HSC20230345H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected IPD, all IPD that underlie results in a publication. IPD will all be deidentified before sharing.
• IPD Sharing Time Frame: When summary data are published or otherwise made available when the study is complete.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No