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

Purpose

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).

Condition

  • Palatal Wound

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention 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.
Primary Purpose
Treatment
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Allogenic amnion chorion membrane 		Allogenic 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
    Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery.
Active Comparator
Collagen dressing 		Collagen dressing is used to cover wounds in dental surgery.
  • Device: Collagen dressing
    Collagen dressing is used to cover wounds in dental surgery.

More Details

Status
Completed
Sponsor
The University of Texas Health Science Center, Houston

Study Contact