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

Sponsor
The University of Texas Health Science Center at San Antonio (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05927714
Collaborator
(none)
74
Enrollment
1
Location
2
Arms
30.1
Anticipated Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Other: Amnion-chorion Membrane
  • Other: ActCel Cellulose Gauze
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
74 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
This is a two-independent arm, parallel-design randomized, prospective trial designed to compare two standard of care techniques.This is a two-independent arm, parallel-design randomized, prospective trial designed to compare two standard of care techniques.
Masking:
Single (Participant)
Masking Description:
Participants will be randomly assigned to either the hemostatic agent or the amnio-chrionic membrane, but will be blinded to which standard of care intervention to which they are assigned.
Primary Purpose:
Treatment
Official Title:
Palatal Donor Site Wound Healing Following Periodontal Plastic Surgery Using Amnion-Chorion Membrane: Site- and Patient-Centered Outcomes
Anticipated Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Feb 1, 2026
Anticipated Study Completion Date :
Feb 1, 2026

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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?

    2. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 89 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Texas Health Science Center at San Antonio (Dental School) San Antonio Texas United States 78229

    Sponsors and Collaborators

    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Brian L Mealey, Professor/Clinical, The University of Texas Health Science Center at San Antonio
    ClinicalTrials.gov Identifier:
    NCT05927714
    Other Study ID Numbers:
    • HSC20230345H
    First Posted:
    Jul 3, 2023
    Last Update Posted:
    Jul 3, 2023
    Last Verified:
    Jun 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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
    Keywords provided by Brian L Mealey, Professor/Clinical, The University of Texas Health Science Center at San Antonio
    Hemostatic agent
    Amnion-chorion membrane
    Accelerated wound healing
    Periodontal plastic surgery
    Additional relevant MeSH terms:
    Wounds and Injuries
    Hemostatics

    Study Results

    No Results Posted as of Jul 3, 2023