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

The University of Texas System (UT)

Status: Completed

Conditions: Palate; Wound

Treatments: Other: ActCel Cellulose Gauze; Other: Amnion-chorion Membrane

Study type: Interventional

Funder types: Other

Identifiers

NCT05927714

HSC20230345H

Details and patient eligibility

About

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).

Full 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.

Enrollment: 74 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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74 participants in 2 patient groups, including a placebo group

Use Amnio Chorion Membrane (ACM) with hemostatic agent

Active Comparator group

Description:

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.

Treatment:

Other: Amnion-chorion Membrane

Other: ActCel Cellulose Gauze

Use of ActCel Cellulose Gauze (Commercial Hemostatic Agent)

Placebo Comparator group

Description:

Palatal wound dressing with hemostatic agent

Treatment:

Other: ActCel Cellulose Gauze