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

Not Applicable

Completed

• Conditions: Palate; Wound
• Interventions: Other: Amnion-chorion Membrane; Other: ActCel Cellulose Gauze

• Registration Number: NCT05927714
• Lead Sponsor: The University of Texas Health Science Center at San Antonio

Brief Summary

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).

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 Timeline

• Study First Submitted: 2023-06-22
• Study First Submitted QC: 2023-06-22
• Study First Posted: 2023-07-03
• Study Start: 2023-09-11
• Status Verified: 2025-04
• Primary Completion: 2025-04-03
• Study Completion: 2025-04-03
• Last Update Submitted: 2025-04-03
• Last Update Posted: 2025-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Use Amnio Chorion Membrane (ACM) with hemostatic agent	Amnion-chorion Membrane	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.
Use Amnio Chorion Membrane (ACM) with hemostatic agent	ActCel Cellulose Gauze	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.
Use of ActCel Cellulose Gauze (Commercial Hemostatic Agent)	ActCel Cellulose Gauze	Palatal wound dressing with hemostatic agent

Primary Outcome Measures

Name	Time	Method
Wound healing time	1, 2, 3 and 4 weeks post-operatively	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?
Post-operative pain	24, 48 and 72 hours post-surgery	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

Trial Locations

Locations (1)

University of Texas Health Science Center at San Antonio (Dental School); 🇺🇸 San Antonio, Texas, United States