Clinical and Histological Outcomes of Allogenic Amnion Chorion Membrane in the Healing of Free Gingival Graft Donor Site
1 other identifier
interventional
19
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 3, 2016
CompletedFirst Submitted
Initial submission to the registry
October 17, 2018
CompletedFirst Posted
Study publicly available on registry
October 19, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 17, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 17, 2020
CompletedResults Posted
Study results publicly available
January 19, 2022
CompletedJanuary 19, 2022
December 1, 2021
3.3 years
October 17, 2018
July 10, 2021
December 17, 2021
Conditions
Outcome Measures
Primary Outcomes (8)
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.
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.
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.
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.
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.
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.
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.
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.
60 days
Secondary Outcomes (56)
Number of Participants Stratified as Per the Degree of Epithelialization of Wound
baseline
Number of Participants Stratified as Per the Degree of Epithelialization of Wound
4 days
Number of Participants Stratified as Per the Degree of Epithelialization of Wound
10 days
Number of Participants Stratified as Per the Degree of Epithelialization of Wound
14 days
Number of Participants Stratified as Per the Degree of Epithelialization of Wound
21 days
- +51 more secondary outcomes
Study Arms (2)
Allogenic amnion chorion membrane
EXPERIMENTALAllogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery.
Collagen dressing
ACTIVE COMPARATORCollagen dressing is used to cover wounds in dental surgery.
Interventions
Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery.
Collagen dressing is used to cover wounds in dental surgery.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
Related Publications (1)
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. 2025 Jul 8. doi: 10.1002/jper.11370. Online ahead of print.
PMID: 40627760DERIVED
Results Point of Contact
- Title
- Chun-Teh Lee, DDS, DMSc, MS
- Organization
- The University of Texas Health Science Center at Houston
Study Officials
- PRINCIPAL INVESTIGATOR
Chun-Teh Lee
The University of Texas Health Science Center, Houston
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
October 17, 2018
First Posted
October 19, 2018
Study Start
October 3, 2016
Primary Completion
January 17, 2020
Study Completion
January 17, 2020
Last Updated
January 19, 2022
Results First Posted
January 19, 2022
Record last verified: 2021-12