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

NCT05927714 | Completed

• 1 other identifier: HSC20230345H
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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).

Conditions

Palate; Wound

Keywords

Hemostatic agent; Amnion-chorion membrane; Accelerated wound healing; Periodontal plastic surgery

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Use Amnio Chorion Membrane (ACM) with hemostatic agent

ACTIVE COMPARATOR

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; Other: ActCel Cellulose Gauze

Use of ActCel Cellulose Gauze (Commercial Hemostatic Agent)

PLACEBO COMPARATOR

Palatal wound dressing with hemostatic agent

Other: ActCel Cellulose Gauze

Interventions

Amnion-chorion Membrane OTHER

Amnio-chorion membranes specifically for palatal wound healing following free soft tissue autografts (FTSA) procedures.

Also known as: ACM

Use Amnio Chorion Membrane (ACM) with hemostatic agent

ActCel Cellulose Gauze OTHER

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.

Also known as: Hemostatic agent

Use Amnio Chorion Membrane (ACM) with hemostatic agent; Use of ActCel Cellulose Gauze (Commercial Hemostatic Agent)

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

University of Texas Health Science Center at San Antonio (Dental School)

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Hemostasis

Intervention Hierarchy (Ancestors)

Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Brian Mealey, DDS, MS

  University of Texas Health Science Center San Antonio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a two-independent arm, parallel-design randomized, prospective trial designed to compare two standard of care techniques.

Study Record Dates

• First Submitted: June 22, 2023
• First Posted: July 3, 2023
• Study Start: September 11, 2023
• Primary Completion: April 3, 2025
• Study Completion: April 3, 2025
• Last Updated: April 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: When summary data are published or otherwise made available when the study is complete.

Locations

US (1)