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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-03

Study Completion Date

2020-01-17

Brief Summary

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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).

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Detailed Description

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Conditions

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Palatal Wound

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Allogenic amnion chorion membrane

Intervention Type DEVICE

Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery.

Collagen dressing

Collagen dressing is used to cover wounds in dental surgery.

Group Type ACTIVE_COMPARATOR

Collagen dressing

Intervention Type DEVICE

Collagen dressing is used to cover wounds in dental surgery.

Interventions

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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.

Intervention Type DEVICE

Collagen dressing

Collagen dressing is used to cover wounds in dental surgery.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No