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

Palate; Wound Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05927714
• Other study ID #: HSC20230345H
• Status: Recruiting
• Phase: N/A
• Start date: September 11, 2023
• Est. completion date: February 2026

Study information

• Verified date: September 2023
• Source: The University of Texas Health Science Center at San Antonio
• Contact: Brian Mealey, DDS, MS
• Phone: 210-450-8736
• Email: mealey[@]uthscsa.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 74
• Est. completion date: February 2026
• Est. primary completion date: February 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Palate; Wound
• Wounds and Injuries

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	University of Texas Health Science Center at San Antonio (Dental School)	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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