Phase II Clinical Trial of Intraoral Grafting of Human Tissue Engineered Oral Mucosa (Small Defect)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by University of Michigan
Sponsor:
Information provided by (Responsible Party):
Stephen E. Feinberg, University of Michigan
ClinicalTrials.gov Identifier:
NCT01834326
First received: April 12, 2013
Last updated: September 20, 2013
Last verified: September 2013
  Purpose

The purpose of this study is to improved the current standard of care of repairing mouth soft tissue defects. This study will test a tissue equivalent ex vivo produced oral mucosa equivalent(EVPOME), which is your 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 your 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. You will be randomly assigned to receive either the EVPOME or POM to cover the defect in your 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.


Condition Intervention Phase
Deficient Keratinized Oral Mucosa for Dental Rehabilitation With Endosseous Dental Implants
Biological: EVPOME (autogenous ex vivo produced oral mucosa equivalent)
Biological: POM (Palatal oral mucosa)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Parallel-group (Autogenous ex Vivo Produced Oral Mucosa Equivalent (EVPOME) vs. Palatal Oral Mucosa (POM) Safety and Efficacy Study in Subjects Requiring Additional Keratinized Oral Mucosa for Dental Rehabilitation With Endosseous Dental Implants

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Clinical increase in zone (width) of keratinized mucosa at grafted site [ Time Frame: 2 and 4 weeks post surgical graft ] [ Designated as safety issue: No ]
    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:
  • Graft contracture [ Time Frame: 2, 4, 8 and 24 weeks after surgery ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Graft blood flow [ Time Frame: 2 and 4 weeks after surgery ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 60
Study Start Date: September 2013
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Palatal oral mucosa (POM)
Patients who require additional keratinized oral mucosa for dental rehabilitation with endosseous dental implants will receive the standard of care palatal oral mucosa (POM)
Biological: POM (Palatal oral mucosa)
Experimental: autogenous ex vivo produced oral mucosa equivalent (EVPOME)
Autogenous ex vivo produced oral mucosa equivalent (EVPOME) grown on AlloDerm in subjects requiring additional keratinized oral mucosa for dental rehabilitation with endosseous dental implants
Biological: EVPOME (autogenous ex vivo produced oral mucosa equivalent)
The EVPOME is manufactured from the subjects own oral cells and is implanted back in the subjects mouth after an approximately 30 day manufacturing process.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01834326

Contacts
Contact: Stephen Feinberg, DDS, PhD 734-763-5963

Locations
United States, Michigan
University of Michigan, Department of Oral & Maxxillofacial Surgery Recruiting
Ann Arbor, Michigan, United States, 48109-5018
Contact: Stephen E Feinberg, DDS, PhD, MS    734-763-5963    sefein@umich.edu   
Contact: Mary Layher, RDH       maryl@umich.edu   
Principal Investigator: Stephen E Feinberg, DDS, PhD, MS         
Sponsors and Collaborators
Stephen E. Feinberg
Investigators
Principal Investigator: Stephen E Feinberg, DDS, PhD, MS University of Michigan
  More Information

No publications provided

Responsible Party: Stephen E. Feinberg, Professor & Associate Chair of Research, University of Michigan
ClinicalTrials.gov Identifier: NCT01834326     History of Changes
Other Study ID Numbers: HUM00065554
Study First Received: April 12, 2013
Last Updated: September 20, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Michigan:
dental implants
deficient keratinized oral mucosa

ClinicalTrials.gov processed this record on July 31, 2014