Palatal Donor Site Wound Healing Following Periodontal Plastic Surgery Using Amnion-Chorion Membrane
NCT ID: NCT05927714
Last Updated: 2025-04-06
Study Results
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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COMPLETED
NA
74 participants
INTERVENTIONAL
2023-09-11
2025-04-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
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.
Amnion-chorion Membrane
Amnio-chorion membranes specifically for palatal wound healing following free soft tissue autografts (FTSA) procedures.
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.
Use of ActCel Cellulose Gauze (Commercial Hemostatic Agent)
Palatal wound dressing with hemostatic agent
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.
Interventions
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Amnion-chorion Membrane
Amnio-chorion membranes specifically for palatal wound healing following free soft tissue autografts (FTSA) procedures.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
89 Years
ALL
Yes
Sponsors
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The University of Texas Health Science Center at San Antonio
OTHER
Responsible Party
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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
Countries
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Other Identifiers
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HSC20230345H
Identifier Type: -
Identifier Source: org_study_id
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