Skip to main content
OpenTrials
Completed

NCT Number: NCT05927714

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas Health Science Center at San Antonio (Dental School)

San Antonio, Texas, 78229, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Amnion-chorion Membrane

Other

Amnio-chorion membranes specifically for palatal wound healing following free soft tissue autografts (FTSA) procedures.

Other names: ACM

ActCel Cellulose Gauze

Other

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

Primary outcomes

  1. Wound healing time

    Time frame: 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?
  2. Post-operative pain

    Time frame: 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

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 3, 2023
Registry last updated
Apr 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.