Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT03713073
NCT03713073CompletedNot Applicable

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

The University of Texas Health Science Center, Houston2 sites in 1 country19 target enrollmentStarted: October 3, 2016Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
19
Locations
2
Primary Endpoint
Size of Wound Area
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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.

Exclusion Criteria

  • •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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Number of Neutrophil Cells as Assessed by Light Microscopy of Haematoxylin and Eosin (H&E)-Stained Biopsy Sections(10 days)
  • Pain as Assessed by a Visual Analogue Scale (VAS)(60 days)
  • Number of Participants Stratified as Per the Degree of Epithelialization of Wound(60 days)
  • Clinician's Feedback on the Wound Dressing Material as Assessed by a Questionnaire(at the time of placement of the wound dressing material)
  • Change in Percentage of Collagen Density in Wound Area as Assessed by Light Microscopy of Masson's Trichrome-stained Biopsy Sections(baseline, 10 days)
  • Number of Participants With Haemostasis of Wound Area(60 days)
  • Relative Difference in Color of Wound Site Compared to Adjacent Gingiva(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)(60 days)
  • Volume of Wound(60 days)
  • Thickness of the Epithelium as Assessed by Light Microscopy of Haematoxylin and Eosin (H&E)-Stained Biopsy Sections(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)(10 days)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Chun-Teh Lee

Assistant Professor

The University of Texas Health Science Center, Houston

Study Sites (2)

Loading locations...

Similar Trials

Completed
Not Applicable
Alveolar Ridge Preservation Using Amniotic Chorion MembraneAlveolar Ridge Preservation
NCT04824235Hams Hamed Abdelrahman20
Completed
Not Applicable
Evaluation of the Effectiveness of an Amnion-chorion Membrane for Alveolar Ridge PreservationHealing Wound
NCT05592158University of Michigan30
Recruiting
Not Applicable
A study to compare the healing effects of amnion and collagen on burn wounds in childre
CTRI/2015/07/005974Dr Reju Joseph Thomas50
Recruiting
Phase 3
Evaluation of the effect of amniotic membrane allograft on duration and costs of treatment in pilonidal disease compared with conventional methodsPilonidal sinus.Pilonidal cyst and sinus without abscessL05.9
IRCT20221008056113N1Mashhad University of Medical Sciences30
Completed
Phase 2
Evaluation of Microinjected Amnion-derived Collagen by Dermapen in the Smoothing of Skin WrinklesFacial Wrinkles - Rough Texture - Hyperpigmentation
NCT06054646Egyptian Atomic Energy Authority20