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Phase II Clinical Trial of Intraoral Grafting of Human Tissue Engineered Oral Mucosa

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01834326
Recruitment Status : Active, not recruiting
First Posted : April 17, 2013
Last Update Posted : November 30, 2018
Information provided by (Responsible Party):
Stephen E. Feinberg, University of Michigan

Brief Summary:
The purpose of this study is to improve the current standard of care of repairing mouth soft tissue defects.

Condition or disease Intervention/treatment Phase
Disorder of Oral Mucous Membrane Biological: EVPOME (autogenous ex vivo produced oral mucosa equivalent) Biological: POM (Palatal oral mucosa) Phase 1 Phase 2

Detailed Description:
This study will test a tissue equivalent ex vivo produced oral mucosa equivalent(EVPOME), which is a subject's own cells grown on top of a piece of AlloDerm (a commercially available freeze dried human cadaver tissue that is routinely used in present day surgical reconstructive procedures) to create a new piece of soft tissue for use only in that subject's body. The tissue equivalent product will be tested against a non-experimental method of grafts, the gold standard a piece of palatal oral mucosa (POM) to see which works best. Each subject will be randomly assigned to receive either the EVPOME or POM to cover the defect in their mouth. The objective of the study is to assess the safety and efficacy for the use of human EVPOME for soft tissue intraoral grafting procedures compared to the "gold standard" palatal oral mucosa (POM) graft.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Parallel-group Autogenous ex Vivo Produced Oral Mucosa Equivalent vs. Palatal Oral Mucosa Safety and Efficacy Study in Subjects Requiring Additional Keratinized Oral Mucosa for Dental Implants
Study Start Date : April 2014
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Arm Intervention/treatment
Active Comparator: Palatal Oral Mucosa (POM) Graft
Standard of care palatal oral mucosa (POM) graft will be taken from the palate and then surgically placed onto the defect area
Biological: POM (Palatal oral mucosa)
POM is a tissue graft harvested from the palate and surgically placed into the defect area

Experimental: Ex vivo Produced Oral Mucosa Equivalent
Palatal biopsy will be harvested for fabrication of autogenous ex vivo produced oral mucosa equivalent (EVPOME) and then surgically placed onto the defect area
Biological: EVPOME (autogenous ex vivo produced oral mucosa equivalent)
EVPOME is manufactured from the subjects own oral cells and is implanted back in the subjects mouth after an approximately 30 day manufacturing process.

Primary Outcome Measures :
  1. Clinical increase in zone (width) of keratinized mucosa at grafted site [ Time Frame: 2 and 4 weeks post surgical graft ]
    The keratinized mucosa (KM) width will be measured by determining the distance from the crest of the edentulous ridge to the mucogingival line to the nearest millimeter with a Castroviejo caliper.

Secondary Outcome Measures :
  1. Graft contracture [ Time Frame: 2, 4, 8 and 24 weeks after surgery ]

Other Outcome Measures:
  1. Graft blood flow [ Time Frame: 2 and 4 weeks after surgery ]
    Graft blood flow will be measured using Laser Doppler flowmetry (LDF) and by immunohistochemistry of a post-graft biopsy for determining number of blood vessels within the dermal component of the graft.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Deficient band (<3mm) of keratinized mucosa prior to or following dental implant placement
  • Surgery to increase width of keratinized mucosa is clinically indicated or requested by the patient to facilitate oral hygiene procedures or to improve esthetics
  • Patients in need of a graft of approximately 15 x 10 x 20 mm in dimension

Exclusion Criteria:

  • Subjects with potential medical complications such as evidence of clinically significant (as described by investigators) renal, hepatic, cardiac, endocrine, hematologic, autoimmune, or any systemic disease which may complication execution of the protocol and/or interpretation of results
  • Current radiation therapy or history of radiation therapy treatment to the intraoral donor biopsy site or recipient site for graft placement
  • Documented history of syphilis, HIV, Hepatitis B or C virus
  • Pregnant women or women planning to become pregnant or unwilling to abstain or use double barrier contraceptives during the course of the study
  • Smoking or use of tobacco products within 6 months prior to screening
  • History of either alcohol or drug abuse
  • Subjects taking medications that can result in gingival enlargement/overgrowth (Cyclosporine, Dilantin, calcium channel blockers)
  • Current use of intravenous bisphosphonate or current oral bisphosphate use or a history of bisphosphonate use for over 5 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01834326

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United States, Michigan
University of Michigan, Department of Oral & Maxxillofacial Surgery
Ann Arbor, Michigan, United States, 48109-5018
Sponsors and Collaborators
Stephen E. Feinberg
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Principal Investigator: Stephen E Feinberg, DDS, PhD, MS University of Michigan

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Responsible Party: Stephen E. Feinberg, Professor & Associate Chair of Research, University of Michigan Identifier: NCT01834326     History of Changes
Other Study ID Numbers: HUM00065554
First Posted: April 17, 2013    Key Record Dates
Last Update Posted: November 30, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Stephen E. Feinberg, University of Michigan:
dental implants
deficient keratinized oral mucosa

Additional relevant MeSH terms:
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Mouth Diseases
Stomatognathic Diseases