Palatal Donor Site Wound Healing Following Periodontal Plastic Surgery Using Amnion-Chorion Membrane
Purpose
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
- Palate; Wound
Eligibility
- Eligible Ages
- Between 18 Years and 89 Years
- Eligible Genders
- 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- 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.
- Primary Purpose
- Treatment
- 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.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
|
Placebo Comparator Use of ActCel Cellulose Gauze (Commercial Hemostatic Agent) |
Palatal wound dressing with hemostatic agent |
|
Recruiting Locations
University of Texas Health Science Center at San Antonio (Dental School)
San Antonio, Texas 78229
San Antonio, Texas 78229
More Details
- Status
- Recruiting
- Sponsor
- The University of Texas Health Science Center at San Antonio
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.