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

The University of Texas System (UT) logo

The University of Texas System (UT)

Status

Completed

Conditions

Palatal Wound

Treatments

Device: Allogenic amnion chorion membrane
Device: Collagen dressing

Study type

Interventional

Funder types

Other

Identifiers

NCT03713073
HSC-DB-18-0303

Details and patient eligibility

About

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).

Enrollment

19 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

19 participants in 2 patient groups

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

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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