Back to resultsPalatal Donor Site Wound Healing Following Periodontal Plastic Surgery Using Amnion-Chorion Membrane
Primary Purpose
Palate; Wound
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Amnion-chorion Membrane
ActCel Cellulose Gauze
Sponsored by
About this trial
This is an interventional treatment trial for Palate; Wound focused on measuring Hemostatic agent, Amnion-chorion membrane, Accelerated wound healing, Periodontal plastic surgery
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
Sites / Locations
- University of Texas Health Science Center at San Antonio (Dental School)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Use Amnio Chorion Membrane (ACM) with hemostatic agent
Use of ActCel Cellulose Gauze (Commercial Hemostatic Agent)
Arm 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.
Palatal wound dressing with hemostatic agent
Outcomes
Primary Outcome Measures
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?
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05927714
First Posted
June 22, 2023
Last Updated
September 25, 2023
Sponsor
The University of Texas Health Science Center at San Antonio
1. Study Identification
Unique Protocol Identification Number
NCT05927714
Brief Title
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 11, 2023 (Actual)
Primary Completion Date
February 2026 (Anticipated)
Study Completion Date
February 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center at San Antonio
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Palate; Wound
Keywords
Hemostatic agent, Amnion-chorion membrane, Accelerated wound healing, Periodontal plastic surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a two-independent arm, parallel-design randomized, prospective trial designed to compare two standard of care techniques.
Masking
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.
Allocation
Randomized
Enrollment
74 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Use Amnio Chorion Membrane (ACM) with hemostatic agent
Arm Type
Active Comparator
Arm 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.
Arm Title
Use of ActCel Cellulose Gauze (Commercial Hemostatic Agent)
Arm Type
Placebo Comparator
Arm Description
Palatal wound dressing with hemostatic agent
Intervention Type
Other
Intervention Name(s)
Amnion-chorion Membrane
Other Intervention Name(s)
ACM
Intervention Description
Amnio-chorion membranes specifically for palatal wound healing following free soft tissue autografts (FTSA) procedures.
Intervention Type
Other
Intervention Name(s)
ActCel Cellulose Gauze
Other Intervention Name(s)
Hemostatic agent
Intervention Description
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.
Primary Outcome Measure Information:
Title
Wound healing time
Description
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?
Time Frame
1, 2, 3 and 4 weeks post-operatively
Title
Post-operative pain
Description
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
Time Frame
24, 48 and 72 hours post-surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brian Mealey, DDS, MS
Phone
210-450-8736
Email
mealey@uthscsa.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Angela Palaiologou-Gallis, DDS
Phone
210-567-3567
Email
palaiologoua@uthscsa.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Mealey, DDS, MS
Organizational Affiliation
University of Texas Health Science Center San Antonio
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Health Science Center at San Antonio (Dental School)
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian L Mealey, DDS, MS
Phone
210-567-3589
Email
mealey@uthscsa.edu
First Name & Middle Initial & Last Name & Degree
Angela Paiologou-Gallis, DDS
Phone
210-567-3567
Email
PalaiologouA@uthscsa.edu
First Name & Middle Initial & Last Name & Degree
Brian L Mealey, DDS, MS
First Name & Middle Initial & Last Name & Degree
Angela Palaiologou-Gallis Palaiologou-Gallis, DDS
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All collected IPD, all IPD that underlie results in a publication. IPD will all be deidentified before sharing.
IPD Sharing Time Frame
When summary data are published or otherwise made available when the study is complete.
Learn more about this trial
Palatal Donor Site Wound Healing Following Periodontal Plastic Surgery Using Amnion-Chorion Membrane
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