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

Study Overview
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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.

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

Conditions
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Palate; Wound

Intervention / Treatment
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* Other: Amnion-chorion Membrane
* Other: ActCel Cellulose Gauze


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a two-independent arm, parallel-design randomized, prospective trial designed to compare two standard of care techniques.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Use Amnio Chorion Membrane (ACM) with hemostatic agent<br>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<br>* Amnio-chorion membranes specifically for palatal wound healing following free soft tissue autografts (FTSA) procedures.<br>* Other names: ACM;Other: ActCel Cellulose Gauze<br>* 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.<br>* Other names: Hemostatic agent;|
| Placebo Comparator: Use of ActCel Cellulose Gauze (Commercial Hemostatic Agent)<br>Palatal wound dressing with hemostatic agent | Other: ActCel Cellulose Gauze<br>* 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.<br>* Other names: Hemostatic agent;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound healing time | 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? | 1, 2, 3 and 4 weeks post-operatively | 
| Post-operative pain | 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 | 24, 48 and 72 hours post-surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemostatic agent, Amnion-chorion membrane, Accelerated wound healing, Periodontal plastic surgery