Palate; WoundNCT05927714
Palatal Donor Site Wound Healing Following Periodontal Plastic Surgery Using Amnion-Chorion Membrane
A study testing Amnion-chorion Membrane and ActCel Cellulose Gauze in people with Palate; Wound, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Palate; Wound
- What is being tested?
- Amnion-chorion Membrane and ActCel Cellulose Gauze
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2023to 3 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Science Center at San Antonio (Dental School)
San Antonio, Texas, 78229
About this study
Official title: Palatal Donor Site Wound Healing Following Periodontal Plastic Surgery Using Amnion-Chorion Membrane: Site- and Patient-Centered Outcomes
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).
Read the 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.
- Conditions
- Palate; Wound
- Being tested
- Amnion-chorion Membrane, ActCel Cellulose Gauze
- Keywords
- Hemostatic agent, Amnion-chorion membrane, Accelerated wound healing, Periodontal plastic surgery
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amnion-chorion MembraneOther
Also called ACM
Amnio-chorion membranes specifically for palatal wound healing following free soft tissue autografts (FTSA) procedures.
ActCel Cellulose GauzeOther
Also called Hemostatic agent
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Amnion-chorion Membrane; Other: ActCel Cellulose Gauze |
| Use of ActCel Cellulose Gauze (Commercial Hemostatic Agent) | Placebo comparator | Palatal wound dressing with hemostatic agent Receives: Other: ActCel Cellulose Gauze |
What is being measured
The primary outcome is the main question the study is designed to answer.
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?
Measured: 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
Measured: 24, 48 and 72 hours post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start11 Sep 2023
- Primary completion3 Apr 2025
- Study completion3 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palate; WoundStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a two-independent arm, parallel-design randomized, prospective trial designed to compare two standard of care techniques.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brian Mealey, DDS, MS, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05927714
- Sponsor's protocol ID
- HSC20230345H
- Status last verified
- Apr 2025
- First submitted
- 22 Jun 2023
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD, all IPD that underlie results in a publication. IPD will all be deidentified before sharing.
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Palatal Donor Site Wound Healing Following Periodontal Plastic Surgery Using Amnion-Chorion Membrane: Site- and Patient-Centered Outcomes
- ClinicalTrials.gov ID
- NCT05927714
- Acronym / sponsor ID
- HSC20230345H
- Conditions
- Palate; Wound
- Keywords
- Hemostatic agent, Amnion-chorion membrane, Accelerated wound healing, Periodontal plastic surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- 11 Sep 2023 (actual)
- Primary completion
- 3 Apr 2025 (actual)
- Study completion
- 3 Apr 2025 (actual)
- First posted
- 3 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This is a two-independent arm, parallel-design randomized, prospective trial designed to compare two standard of care techniques.
| Arm | Type | Receives |
|---|---|---|
| Use Amnio Chorion Membrane (ACM) with hemostatic agent | Active comparator | Other: Amnion-chorion Membrane, Other: ActCel Cellulose GauzeACM 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. |
| Use of ActCel Cellulose Gauze (Commercial Hemostatic Agent) | Placebo comparator | Other: ActCel Cellulose GauzePalatal wound dressing with hemostatic agent |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amnion-chorion MembraneAlso: ACMAmnio-chorion membranes specifically for palatal wound healing following free soft tissue autografts (FTSA) procedures. | Other | Use Amnio Chorion Membrane (ACM) with hemostatic agent |
| ActCel Cellulose GauzeAlso: Hemostatic agentWhen 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. | Other | Use Amnio Chorion Membrane (ACM) with hemostatic agent, Use of ActCel Cellulose Gauze (Commercial Hemostatic Agent) |
Primary outcome
Wound healing time
Time frame: 1, 2, 3 and 4 weeks post-operatively
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
Time frame: 24, 48 and 72 hours post-surgery
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Individual participant dataSharing planned: Yes. All collected IPD, all IPD that underlie results in a publication. IPD will all be deidentified before sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Mealey, DDS, MS principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amnion-chorion Membrane and ActCel Cellulose Gauze in people with Palate; Wound, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound healing time (time frame: 1, 2, 3 and 4 weeks post-operatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.