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

NCT ID: NCT05927714

Last Updated: 2025-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-11

Study Completion Date

2025-04-03

Brief Summary

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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

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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.

Conditions

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Palate; Wound

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a two-independent arm, parallel-design randomized, prospective trial designed to compare two standard of care techniques.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
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.

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Amnion-chorion Membrane

Intervention Type OTHER

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

ActCel Cellulose Gauze

Intervention Type 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.

Use of ActCel Cellulose Gauze (Commercial Hemostatic Agent)

Palatal wound dressing with hemostatic agent

Group Type PLACEBO_COMPARATOR

ActCel Cellulose Gauze

Intervention Type 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.

Interventions

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Amnion-chorion Membrane

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

Intervention Type 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.

Intervention Type OTHER

Other Intervention Names

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ACM Hemostatic agent

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Brian Mealey, DDS, MS

Role: PRINCIPAL_INVESTIGATOR

University of Texas Health Science Center San Antonio

Locations

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

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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HSC20230345H

Identifier Type: -

Identifier Source: org_study_id

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