Palatal WoundNCT03713073

Clinical and Histological Outcomes of Allogenic Amnion Chorion Membrane in the Healing of Free Gingival Graft Donor Site

A study testing Allogenic amnion chorion membrane and Collagen dressing in people with Palatal Wound, run by The University of Texas Health Science Center, Houston at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to compare an allogenic amnion chorion membrane to a collagen dressing in palatal wound healing after harvesting free gingival graft (FGG). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Palatal Wound
What is being tested?: Allogenic amnion chorion membrane and Collagen dressing
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 19 participants
Where: 1 siteUnited States
Study dates: 3 Oct 2016to 17 Jan 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

patients attending the Clinic for Graduate Periodontics at The University of Texas health Science Center at Houston School of Dentistry who are in need of a Free Gingival Graft procedure to augment keratinized gingiva, augment ridge, or cover recession defects.
systemically healthy or with controlled common systemic conditions, such as hypertension, that will not affect wound healing.

Who cannot join

size of the FGG that the patient needs bigger than the size of FGGs that have to be harvested in this study (two 8mm (width) x 10mm (length) x ≈1.5mm (thickness) FGG).
current heavy smokers(>10 cigarettes/day) (patients who stop smoking more than one year are eligible)
have diabetes or other systemic diseases that may comprise healing
take antibiotics and/or analgesics within one week before the procedure and have loss of sensation on the palate

Trial locations and contacts

1 site in 1 country.

United States1 site

The University of Texas Health Science Center at Houston
Houston, Texas, 77030

Other trials in United States

About this study

The purpose of this study is to compare an allogenic amnion chorion membrane to a collagen dressing in palatal wound healing after harvesting free gingival graft (FGG).

Conditions: Palatal Wound
Being tested: Allogenic amnion chorion membrane, Collagen dressing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Allogenic amnion chorion membraneDevice
Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery.
Collagen dressingDevice
Collagen dressing is used to cover wounds in dental surgery.

Study groups in NCT03713073
Study group	Role	What they receive
Allogenic amnion chorion membrane	Experimental	Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery. Receives: Device: Allogenic amnion chorion membrane
Collagen dressing	Active comparator	Collagen dressing is used to cover wounds in dental surgery. Receives: Device: Collagen dressing

What is being measured

The primary outcome is the main question the study is designed to answer.

Size of Wound Area
The wound area will be assessed by means of a clinical picture. The picture will be taken with an angulation perpendicular to the wound. A periodontal probe will be placed by the wound as a reference scale. Wound area is defined as the area without epithelization. The wound area on the picture will be measured by ImageJ.
Measured: baseline
Size of Wound Area
The wound area will be assessed by means of a clinical picture. The picture will be taken with an angulation perpendicular to the wound. A periodontal probe will be placed by the wound as a reference scale. Wound area is defined as the area without epithelization. The wound area on the picture will be measured by ImageJ.
Measured: 4 days
Size of Wound Area
The wound area will be assessed by means of a clinical picture. The picture will be taken with an angulation perpendicular to the wound. A periodontal probe will be placed by the wound as a reference scale. Wound area is defined as the area without epithelization. The wound area on the picture will be measured by ImageJ.
Measured: 10 days
Size of Wound Area
The wound area will be assessed by means of a clinical picture. The picture will be taken with an angulation perpendicular to the wound. A periodontal probe will be placed by the wound as a reference scale. Wound area is defined as the area without epithelization. The wound area on the picture will be measured by ImageJ.
Measured: 14 days
Size of Wound Area
The wound area will be assessed by means of a clinical picture. The picture will be taken with an angulation perpendicular to the wound. A periodontal probe will be placed by the wound as a reference scale. Wound area is defined as the area without epithelization. The wound area on the picture will be measured by ImageJ.
Measured: 21 days
Size of Wound Area
The wound area will be assessed by means of a clinical picture. The picture will be taken with an angulation perpendicular to the wound. A periodontal probe will be placed by the wound as a reference scale. Wound area is defined as the area without epithelization. The wound area on the picture will be measured by ImageJ.
Measured: 28 days
Size of Wound Area
The wound area will be assessed by means of a clinical picture. The picture will be taken with an angulation perpendicular to the wound. A periodontal probe will be placed by the wound as a reference scale. Wound area is defined as the area without epithelization. The wound area on the picture will be measured by ImageJ.
Measured: 45 days
Size of Wound Area
The wound area will be assessed by means of a clinical picture. The picture will be taken with an angulation perpendicular to the wound. A periodontal probe will be placed by the wound as a reference scale. Wound area is defined as the area without epithelization. The wound area on the picture will be measured by ImageJ.
Measured: 60 days

Secondary outcomes (56)

Number of Participants Stratified as Per the Degree of Epithelialization of Wound
Epithelialization is measured by means of bubble formation after dripping hydrogen peroxide (3%) to the wound surface. Less bubbles indicate greater epithelialization, and epithelialization will be ranked as total, partial or none.
Measured: baseline
Number of Participants Stratified as Per the Degree of Epithelialization of Wound
Epithelialization is measured by means of bubble formation after dripping hydrogen peroxide (3%) to the wound surface. Less bubbles indicate greater epithelialization, and epithelialization will be ranked as total, partial or none.
Measured: 4 days
Number of Participants Stratified as Per the Degree of Epithelialization of Wound
Epithelialization is measured by means of bubble formation after dripping hydrogen peroxide (3%) to the wound surface. Less bubbles indicate greater epithelialization, and epithelialization will be ranked as total, partial or none.
Measured: 10 days
Number of Participants Stratified as Per the Degree of Epithelialization of Wound
Epithelialization is measured by means of bubble formation after dripping hydrogen peroxide (3%) to the wound surface. Less bubbles indicate greater epithelialization, and epithelialization will be ranked as total, partial or none.
Measured: 14 days
Number of Participants Stratified as Per the Degree of Epithelialization of Wound
Epithelialization is measured by means of bubble formation after dripping hydrogen peroxide (3%) to the wound surface. Less bubbles indicate greater epithelialization, and epithelialization will be ranked as total, partial or none.
Measured: 21 days
Number of Participants Stratified as Per the Degree of Epithelialization of Wound
Epithelialization is measured by means of bubble formation after dripping hydrogen peroxide (3%) to the wound surface. Less bubbles indicate greater epithelialization, and epithelialization will be ranked as total, partial or none.
Measured: 28 days
Number of Participants Stratified as Per the Degree of Epithelialization of Wound
Epithelialization is measured by means of bubble formation after dripping hydrogen peroxide (3%) to the wound surface. Less bubbles indicate greater epithelialization, and epithelialization will be ranked as total, partial or none.
Measured: 45 days
Number of Participants Stratified as Per the Degree of Epithelialization of Wound
Epithelialization is measured by means of bubble formation after dripping hydrogen peroxide (3%) to the wound surface. Less bubbles indicate greater epithelialization, and epithelialization will be ranked as total, partial or none.
Measured: 60 days
Relative Difference in Color of Wound Site Compared to Adjacent Gingiva
The color of wound site will be compared to the adjacent gingiva by using a 4-point scale: 1. Obvious difference; 2. Noticeable difference; 3. Disguisable difference; or 4. No noticeable difference in comparison with adjacent gingiva.
Measured: baseline
Relative Difference in Color of Wound Site Compared to Adjacent Gingiva
The color of wound site will be compared to the adjacent gingiva by using a 4-point scale: 1. Obvious difference; 2. Noticeable difference; 3. Disguisable difference; or 4. No noticeable difference in comparison with adjacent gingiva.
Measured: 4 days
Relative Difference in Color of Wound Site Compared to Adjacent Gingiva
The color of wound site will be compared to the adjacent gingiva by using a 4-point scale: 1. Obvious difference; 2. Noticeable difference; 3. Disguisable difference; or 4. No noticeable difference in comparison with adjacent gingiva.
Measured: 10 days
Relative Difference in Color of Wound Site Compared to Adjacent Gingiva
The color of wound site will be compared to the adjacent gingiva by using a 4-point scale: 1. Obvious difference; 2. Noticeable difference; 3. Disguisable difference; or 4. No noticeable difference in comparison with adjacent gingiva.
Measured: 14 days
Relative Difference in Color of Wound Site Compared to Adjacent Gingiva
The color of wound site will be compared to the adjacent gingiva by using a 4-point scale: 1. Obvious difference; 2. Noticeable difference; 3. Disguisable difference; or 4. No noticeable difference in comparison with adjacent gingiva.
Measured: 21 days
Relative Difference in Color of Wound Site Compared to Adjacent Gingiva
The color of wound site will be compared to the adjacent gingiva by using a 4-point scale: 1. Obvious difference; 2. Noticeable difference; 3. Disguisable difference; or 4. No noticeable difference in comparison with adjacent gingiva.
Measured: 28 days
Relative Difference in Color of Wound Site Compared to Adjacent Gingiva
The color of wound site will be compared to the adjacent gingiva by using a 4-point scale: 1. Obvious difference; 2. Noticeable difference; 3. Disguisable difference; or 4. No noticeable difference in comparison with adjacent gingiva.
Measured: 45 days
Relative Difference in Color of Wound Site Compared to Adjacent Gingiva
The color of wound site will be compared to the adjacent gingiva by using a 4-point scale: 1. Obvious difference; 2. Noticeable difference; 3. Disguisable difference; or 4. No noticeable difference in comparison with adjacent gingiva.
Measured: 60 days
Number of Participants With Haemostasis of Wound Area
Haemostasis is achieved when no bleeding of the wound site is actively seen.
Measured: baseline
Number of Participants With Haemostasis of Wound Area
Haemostasis is achieved when no bleeding of the wound site is actively seen.
Measured: 4 days
Number of Participants With Haemostasis of Wound Area
Haemostasis is achieved when no bleeding of the wound site is actively seen.
Measured: 10 days
Number of Participants With Haemostasis of Wound Area
Haemostasis is achieved when no bleeding of the wound site is actively seen.
Measured: 14 days
Number of Participants With Haemostasis of Wound Area
Haemostasis is achieved when no bleeding of the wound site is actively seen.
Measured: 21 days
Number of Participants With Haemostasis of Wound Area
Haemostasis is achieved when no bleeding of the wound site is actively seen.
Measured: 28 days
Number of Participants With Haemostasis of Wound Area
Haemostasis is achieved when no bleeding of the wound site is actively seen.
Measured: 45 days
Number of Participants With Haemostasis of Wound Area
Haemostasis is achieved when no bleeding of the wound site is actively seen.
Measured: 60 days
Pain as Assessed by a Visual Analogue Scale (VAS)
Pain will be assessed by a Visual Analogue Scale (VAS). Scores range form 0 to 10. 0 indicates no pain, 1 indicates minimal pain, and 10 indicates severe pain.
Measured: baseline
Pain as Assessed by a Visual Analogue Scale (VAS)
Pain will be assessed by a Visual Analogue Scale (VAS). Scores range form 0 to 10. 0 indicates no pain, 1 indicates minimal pain, and 10 indicates severe pain.
Measured: 4 days
Pain as Assessed by a Visual Analogue Scale (VAS)
Pain will be assessed by a Visual Analogue Scale (VAS). Scores range form 0 to 10. 0 indicates no pain, 1 indicates minimal pain, and 10 indicates severe pain.
Measured: 10 days
Pain as Assessed by a Visual Analogue Scale (VAS)
Pain will be assessed by a Visual Analogue Scale (VAS). Scores range form 0 to 10. 0 indicates no pain, 1 indicates minimal pain, and 10 indicates severe pain.
Measured: 14 days
Pain as Assessed by a Visual Analogue Scale (VAS)
Pain will be assessed by a Visual Analogue Scale (VAS). Scores range form 0 to 10. 0 indicates no pain, 1 indicates minimal pain, and 10 indicates severe pain.
Measured: 21 days
Pain as Assessed by a Visual Analogue Scale (VAS)
Pain will be assessed by a Visual Analogue Scale (VAS). Scores range form 0 to 10. 0 indicates no pain, 1 indicates minimal pain, and 10 indicates severe pain.
Measured: 28 days
Pain as Assessed by a Visual Analogue Scale (VAS)
Pain will be assessed by a Visual Analogue Scale (VAS). Scores range form 0 to 10. 0 indicates no pain, 1 indicates minimal pain, and 10 indicates severe pain.
Measured: 45 days
Pain as Assessed by a Visual Analogue Scale (VAS)
Pain will be assessed by a Visual Analogue Scale (VAS). Scores range form 0 to 10. 0 indicates no pain, 1 indicates minimal pain, and 10 indicates severe pain.
Measured: 60 days
Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS)
Sensibility will be assessed with a periodontal probe using a rubbing movement and pin-pressure nociception. Patients will be asked to rate their sensitivity based on a 3-point verbal descriptor scale (VDS): no loss of sensation, mild/moderate loss of sensation, or severe loss of sensation.
Measured: baseline
Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS)
Sensibility will be assessed with a periodontal probe using a rubbing movement and pin-pressure nociception. Patients will be asked to rate their sensibility based on a 3-point verbal descriptor scale (VDS): no loss of sensation, mild/moderate loss of sensation, or severe loss of sensation.
Measured: 4 days
Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS)
Sensibility will be assessed with a periodontal probe using a rubbing movement and pin-pressure nociception. Patients will be asked to rate their sensibility based on a 3-point verbal descriptor scale (VDS): no loss of sensation, mild/moderate loss of sensation, or severe loss of sensation.
Measured: 10 days
Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS)
Sensibility will be assessed with a periodontal probe using a rubbing movement and pin-pressure nociception. Patients will be asked to rate their sensibility based on a 3-point verbal descriptor scale (VDS): no loss of sensation, mild/moderate loss of sensation, or severe loss of sensation.
Measured: 14 days
Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS)
Sensibility will be assessed with a periodontal probe using a rubbing movement and pin-pressure nociception. Patients will be asked to rate their sensibility based on a 3-point verbal descriptor scale (VDS): no loss of sensation, mild/moderate loss of sensation, or severe loss of sensation.
Measured: 21 days
Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS)
Sensibility will be assessed with a periodontal probe using a rubbing movement and pin-pressure nociception. Patients will be asked to rate their sensibility based on a 3-point verbal descriptor scale (VDS): no loss of sensation, mild/moderate loss of sensation, or severe loss of sensation.
Measured: 28 days
Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS)
Sensibility will be assessed with a periodontal probe using a rubbing movement and pin-pressure nociception. Patients will be asked to rate their sensibility based on a 3-point verbal descriptor scale (VDS): no loss of sensation, mild/moderate loss of sensation, or severe loss of sensation.
Measured: 45 days
Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS)
Sensibility will be assessed with a periodontal probe using a rubbing movement and pin-pressure nociception. Patients will be asked to rate their sensibility based on a 3-point verbal descriptor scale (VDS): no loss of sensation, mild/moderate loss of sensation, or severe loss of sensation.
Measured: 60 days
Volume of Wound
The wound area will analyzed with an intraoral scanner, and three-dimensional images will be reconstructed to determine the volume of the wound.
Measured: baseline
Volume of Wound
The wound area will analyzed with an intraoral scanner, and three-dimensional images will be reconstructed to determine the volume of the wound.
Measured: 4 days
Volume of Wound
The wound area will analyzed with an intraoral scanner, and three-dimensional images will be reconstructed to determine the volume of the wound.
Measured: 10 days
Volume of Wound
The wound area will analyzed with an intraoral scanner, and three-dimensional images will be reconstructed to determine the volume of the wound.
Measured: 14 days
Volume of Wound
The wound area will analyzed with an intraoral scanner, and three-dimensional images will be reconstructed to determine the volume of the wound.
Measured: 21 days
Volume of Wound
The wound area will analyzed with an intraoral scanner, and three-dimensional images will be reconstructed to determine the volume of the wound.
Measured: 28 days
Volume of Wound
The wound area will analyzed with an intraoral scanner, and three-dimensional images will be reconstructed to determine the volume of the wound.
Measured: 45 days
Volume of Wound
The wound area will analyzed with an intraoral scanner, and three-dimensional images will be reconstructed to determine the volume of the wound.
Measured: 60 days
Clinician's Feedback on the Wound Dressing Material as Assessed by a Questionnaire
Measured: at the time of placement of the wound dressing material
Number of Neutrophil Cells as Assessed by Light Microscopy of Haematoxylin and Eosin (H&E)-Stained Biopsy Sections
Gingival specimen biopsies (4mm in diameter, 1.5mm in thickness) will be harvested. The histological sections will be evaluated using a Nikon light microscope.
Measured: baseline
Number of Neutrophil Cells as Assessed by Light Microscopy of Haematoxylin and Eosin (H&E)-Stained Biopsy Sections
Gingival specimen biopsies (4mm in diameter, 1.5mm in thickness) will be harvested. The histological sections will be evaluated using a Nikon light microscope.
Measured: 10 days
Change in Percentage of Collagen Density in Wound Area as Assessed by Light Microscopy of Masson's Trichrome-stained Biopsy Sections
Measured: baseline, 10 days
Thickness of the Epithelium as Assessed by Light Microscopy of Haematoxylin and Eosin (H&E)-Stained Biopsy Sections
Gingival specimen biopsies (4mm in diameter, 1.5mm in thickness) will be harvested. The histological sections will be evaluated using a Nikon light microscope, and Nikon NIS-Elements Advanced Research (AR) Imagine Software will be used to calculate the thickness of the epithelium.
Measured: baseline
Thickness of the Epithelium as Assessed by Light Microscopy of Haematoxylin and Eosin (H&E)-Stained Biopsy Sections
Gingival specimen biopsies (4mm in diameter, 1.5mm in thickness) will be harvested. The histological sections will be evaluated using a Nikon light microscope, and Nikon NIS-Elements Advanced Research (AR) Imagine Software will be used to calculate the thickness of the epithelium.
Measured: 10 days
Angiogenesis as Indicated by Number of Blood Vessels as Assessed by Light Microscopy of Biopsy Sections Immunohistochemically Stained to Detect Factor VIII (Von Willebrandt Factor)
Measured: baseline
Angiogenesis as Indicated by Number of Blood Vessels as Assessed by Light Microscopy of Biopsy Sections Immunohistochemically Stained to Detect Factor VIII (Von Willebrandt Factor)
Gingival specimen biopsies (4mm in diameter, 1.5mm in thickness) will be harvested. The histological sections will be evaluated using a Nikon light microscope, and the area of angiogenesis will be quantified using Nikon NIS Element AR Imagine Software.
Measured: 10 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Oct 201617 Jan 2020

First posted19 Oct 2018
Study start3 Oct 2016
Primary completion17 Jan 2020
Study completion17 Jan 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Palatal WoundStudies of the same condition, open and under way.
More trials run by The University of Texas Health Science Center, HoustonThe 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: The study is a "split-mouth design," in which two treatments (test and control) are randomly assigned to either the right or left halves of the dentition/palate.
Masking: Single blind
Who is masked: Participant
Enrolment: 19 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03713073
Sponsor's protocol ID: HSC-DB-18-0303
Status last verified: Dec 2021
First submitted: 17 Oct 2018
Last updated: 19 Jan 2022
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes

Publications

Lee CT, Umoh EN, Husain A, Gomnam N, Tribble G, Wang BY, Min S. Clinical and histological outcomes of allogenic amnion-chorion membrane for palatal donor site healing. J Periodontol. 2026 Feb;97(2):188-197. doi: 10.1002/jper.11370. Epub 2025 Jul 8.
PubMed 40627760

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Palatal Wound Healing After Free Gingival Graft Harvest in Diabetic Patients: A Clinical Trial
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Dynamics of Wound Healing in Patients With Obesity
Wound Healing
Active, not recruiting
Effect of Frankincense Versus Palatal Stent on Palatal Donor Site Healing
Palatal Donor Site Wound Healing
Recruiting
Patient-reported Outcomes of Donor Site Healing Using Different Palatal Protection Techniques
Mucosal Erosion, Gingival Recession

All Palatal Wound trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical and Histological Outcomes of Allogenic Amnion Chorion Membrane in the Healing of Free Gingival Graft Donor Site
ClinicalTrials.gov ID: NCT03713073
Acronym / sponsor ID: HSC-DB-18-0303
Conditions: Palatal Wound
Study type: Interventional
Recruitment status: Completed
Enrolment: 19 participants (actual)
Lead sponsor: The University of Texas Health Science Center, HoustonUniversity, hospital or other
Study start: 3 Oct 2016 (actual)
Primary completion: 17 Jan 2020 (actual)
Study completion: 17 Jan 2020 (actual)
First posted: 19 Oct 2018 (actual)
Results: Posted 19 Jan 2022

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 study is to compare an allogenic amnion chorion membrane to a collagen dressing in palatal wound healing after harvesting free gingival graft (FGG).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
Model description: The study is a "split-mouth design," in which two treatments (test and control) are randomly assigned to either the right or left halves of the dentition/palate.

Arm	Type	Receives
Allogenic amnion chorion membrane	Experimental	Device: Allogenic amnion chorion membraneAllogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery.
Collagen dressing	Active comparator	Device: Collagen dressingCollagen dressing is used to cover wounds in dental surgery.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

patients attending the Clinic for Graduate Periodontics at The University of Texas health Science Center at Houston School of Dentistry who are in need of a Free Gingival Graft procedure to augment keratinized gingiva, augment ridge, or cover recession defects.
systemically healthy or with controlled common systemic conditions, such as hypertension, that will not affect wound healing.

Key exclusion criteria (4 listed)

size of the FGG that the patient needs bigger than the size of FGGs that have to be harvested in this study (two 8mm (width) x 10mm (length) x ≈1.5mm (thickness) FGG).
current heavy smokers(>10 cigarettes/day) (patients who stop smoking more than one year are eligible)
have diabetes or other systemic diseases that may comprise healing
take antibiotics and/or analgesics within one week before the procedure and have loss of sensation on the palate

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
Allogenic amnion chorion membraneAllogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery.	Device	Allogenic amnion chorion membrane
Collagen dressingCollagen dressing is used to cover wounds in dental surgery.	Device	Collagen dressing

Primary outcome

Size of Wound Area
Time frame: baseline
The wound area will be assessed by means of a clinical picture. The picture will be taken with an angulation perpendicular to the wound. A periodontal probe will be placed by the wound as a reference scale. Wound area is defined as the area without epithelization. The wound area on the picture will be measured by ImageJ.
Size of Wound Area
Time frame: 4 days
The wound area will be assessed by means of a clinical picture. The picture will be taken with an angulation perpendicular to the wound. A periodontal probe will be placed by the wound as a reference scale. Wound area is defined as the area without epithelization. The wound area on the picture will be measured by ImageJ.
Size of Wound Area
Time frame: 10 days
The wound area will be assessed by means of a clinical picture. The picture will be taken with an angulation perpendicular to the wound. A periodontal probe will be placed by the wound as a reference scale. Wound area is defined as the area without epithelization. The wound area on the picture will be measured by ImageJ.
Size of Wound Area
Time frame: 14 days
The wound area will be assessed by means of a clinical picture. The picture will be taken with an angulation perpendicular to the wound. A periodontal probe will be placed by the wound as a reference scale. Wound area is defined as the area without epithelization. The wound area on the picture will be measured by ImageJ.
Size of Wound Area
Time frame: 21 days
The wound area will be assessed by means of a clinical picture. The picture will be taken with an angulation perpendicular to the wound. A periodontal probe will be placed by the wound as a reference scale. Wound area is defined as the area without epithelization. The wound area on the picture will be measured by ImageJ.
Size of Wound Area
Time frame: 28 days
The wound area will be assessed by means of a clinical picture. The picture will be taken with an angulation perpendicular to the wound. A periodontal probe will be placed by the wound as a reference scale. Wound area is defined as the area without epithelization. The wound area on the picture will be measured by ImageJ.
Size of Wound Area
Time frame: 45 days
The wound area will be assessed by means of a clinical picture. The picture will be taken with an angulation perpendicular to the wound. A periodontal probe will be placed by the wound as a reference scale. Wound area is defined as the area without epithelization. The wound area on the picture will be measured by ImageJ.
Size of Wound Area
Time frame: 60 days
The wound area will be assessed by means of a clinical picture. The picture will be taken with an angulation perpendicular to the wound. A periodontal probe will be placed by the wound as a reference scale. Wound area is defined as the area without epithelization. The wound area on the picture will be measured by ImageJ.

56 secondary outcomes

Number of Participants Stratified as Per the Degree of Epithelialization of Wound
Time frame: baseline
Number of Participants Stratified as Per the Degree of Epithelialization of Wound
Time frame: 4 days
Number of Participants Stratified as Per the Degree of Epithelialization of Wound
Time frame: 10 days
Number of Participants Stratified as Per the Degree of Epithelialization of Wound
Time frame: 14 days
Number of Participants Stratified as Per the Degree of Epithelialization of Wound
Time frame: 21 days
Number of Participants Stratified as Per the Degree of Epithelialization of Wound
Time frame: 28 days
Number of Participants Stratified as Per the Degree of Epithelialization of Wound
Time frame: 45 days
Number of Participants Stratified as Per the Degree of Epithelialization of Wound
Time frame: 60 days
Relative Difference in Color of Wound Site Compared to Adjacent Gingiva
Time frame: baseline
Relative Difference in Color of Wound Site Compared to Adjacent Gingiva
Time frame: 4 days
Relative Difference in Color of Wound Site Compared to Adjacent Gingiva
Time frame: 10 days
Relative Difference in Color of Wound Site Compared to Adjacent Gingiva
Time frame: 14 days
Relative Difference in Color of Wound Site Compared to Adjacent Gingiva
Time frame: 21 days
Relative Difference in Color of Wound Site Compared to Adjacent Gingiva
Time frame: 28 days
Relative Difference in Color of Wound Site Compared to Adjacent Gingiva
Time frame: 45 days
Relative Difference in Color of Wound Site Compared to Adjacent Gingiva
Time frame: 60 days
Number of Participants With Haemostasis of Wound Area
Time frame: baseline
Number of Participants With Haemostasis of Wound Area
Time frame: 4 days
Number of Participants With Haemostasis of Wound Area
Time frame: 10 days
Number of Participants With Haemostasis of Wound Area
Time frame: 14 days
Number of Participants With Haemostasis of Wound Area
Time frame: 21 days
Number of Participants With Haemostasis of Wound Area
Time frame: 28 days
Number of Participants With Haemostasis of Wound Area
Time frame: 45 days
Number of Participants With Haemostasis of Wound Area
Time frame: 60 days
Pain as Assessed by a Visual Analogue Scale (VAS)
Time frame: baseline
Pain as Assessed by a Visual Analogue Scale (VAS)
Time frame: 4 days
Pain as Assessed by a Visual Analogue Scale (VAS)
Time frame: 10 days
Pain as Assessed by a Visual Analogue Scale (VAS)
Time frame: 14 days
Pain as Assessed by a Visual Analogue Scale (VAS)
Time frame: 21 days
Pain as Assessed by a Visual Analogue Scale (VAS)
Time frame: 28 days
Pain as Assessed by a Visual Analogue Scale (VAS)
Time frame: 45 days
Pain as Assessed by a Visual Analogue Scale (VAS)
Time frame: 60 days
Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS)
Time frame: baseline
Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS)
Time frame: 4 days
Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS)
Time frame: 10 days
Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS)
Time frame: 14 days
Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS)
Time frame: 21 days
Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS)
Time frame: 28 days
Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS)
Time frame: 45 days
Sensibility of the Wound Area as Indicated by Number of Participants Who Lost Sensation as Assessed by a 3-point Verbal Descriptor Scale (VDS)
Time frame: 60 days

Results and safety

Results posted to the registry on 19 Jan 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Participants	19	19

Primary outcome: Size of Wound Area

Time frame: baseline. Mean (Standard Deviation). Unit: micrometers (μm)

Measure	Allogenic Amnion Chorion Membrane n = 19	Collagen Dressing n = 19
Value	80 (0)	80 (0)

Primary outcome: Size of Wound Area

Time frame: 4 days. Mean (Standard Deviation). Unit: micrometers (μm)

Measure	Allogenic Amnion Chorion Membrane n = 19	Collagen Dressing n = 19
Value	35.9 (12.2)	37.3 (12.9)

Primary outcome: Size of Wound Area

Time frame: 10 days. Mean (Standard Deviation). Unit: micrometers (μm)

Measure	Allogenic Amnion Chorion Membrane n = 15	Collagen Dressing n = 15
Value	22.9 (10.7)	25.6 (10.2)

Population analysed: Data for this outcome were not collected for four in the allogenic amnion chorion membrane arm and four in the collagen dressing arm.

Primary outcome: Size of Wound Area

Time frame: 14 days. Mean (Standard Deviation). Unit: micrometers (μm)

Measure	Allogenic Amnion Chorion Membrane n = 18	Collagen Dressing n = 18
Value	13.3 (9.1)	14.1 (7.9)

Population analysed: Data for this outcome were not collected for one in the allogenic amnion chorion membrane arm and one in the collagen dressing arm.

56 secondary outcomes are reported in the full results.

Adverse events

Time frame: 60 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Allogenic Amnion Chorion Membrane	0 of 19 (0%)	0 of 19 (0%)	0 of 19
Collagen Dressing	0 of 19 (0%)	0 of 19 (0%)	0 of 19

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40627760Lee CT, Umoh EN, Husain A, Gomnam N, Tribble G, Wang BY, Min S. Clinical and histological outcomes of allogenic amnion-chorion membrane for palatal donor site healing. J Periodontol. 2026 Feb;97(2):188-197. doi: 10.1002/jper.11370. Epub 2025 Jul 8.

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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.

Chun-Teh Lee principal investigator

The University of Texas Health Science Center, Houston

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Allogenic amnion chorion membrane and Collagen dressing in people with Palatal Wound, run by The University of Texas Health Science Center, Houston 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 2 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 19 Jan 2022. 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. 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?

Yes. Results are posted in the registry (first posted 19 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Size of Wound Area (time frame: baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03713073, which also lists 1 linked publication.

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 19 Jan 2022.