Clinical trial NCT05927714: Palatal Donor Site Wound Healing Following Periodontal Plastic Surgery Using Amnion-Chorion Membrane
Official title: Palatal Donor Site Wound Healing Following Periodontal Plastic Surgery Using Amnion-Chorion Membrane: Site- and Patient-Centered Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Palate; Wound
Keywords: Hemostatic agent
Amnion-chorion membrane
Accelerated wound healing
Periodontal plastic surgery
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Wound healing time
timeFrame: 1, 2, 3 and 4 weeks post-operatively
measure: Post-operative pain
timeFrame: 24, 48 and 72 hours post-surgery
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio (Dental School)
state: Texas
Study officials:
affiliation: University of Texas Health Science Center San Antonio
name: Brian Mealey, DDS, MS
role: PRINCIPAL_INVESTIGATOR
References: