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

NCT01834326 | Terminated Phase 2 Results DMC

• 1 other identifier: HUM00065554
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Disorder of Oral Mucous Membrane

Keywords

dental implants; deficient keratinized oral mucosa

Outcome Measures

Primary Outcomes (1)

• Clinical Increase in Zone (Width) of Keratinized Mucosa at Grafted Site

  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. The keratinized mucosa width of study subjects was measured prior to graft placement and then after two weeks, and after 4 weeks. The data provided shows the difference in keratinized mucosa width between the pre surgery measure and the post surgery measure. More mucosa width (positive numbers in mm) is an improvement, negative numbers (a decrease) would be less good.

  2 and 4 weeks post surgical graft

Secondary Outcomes (1)

• Graft Contracture

  2, 4, 8 and 24 weeks after surgery

Other Outcomes (2)

• Graft Blood Flow

  2 and 4 weeks after surgery

• Immunohistochemistry Using Anti-CD31 (Cluster of Differentiation 31) to Detect Blood Vessel Growth Into the Graft.

  4 weeks after graft surgery

Study Arms (2)

Palatal Oral Mucosa (POM) Graft

ACTIVE COMPARATOR

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)

Ex vivo Produced Oral Mucosa Equivalent

EXPERIMENTAL

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)

Interventions

EVPOME (autogenous ex vivo produced oral mucosa equivalent) BIOLOGICAL

EVPOME is manufactured from the subjects own oral cells and is implanted back in the subjects mouth after an approximately 30 day manufacturing process.

Ex vivo Produced Oral Mucosa Equivalent

POM (Palatal oral mucosa) BIOLOGICAL

POM is a tissue graft harvested from the palate and surgically placed into the defect area

Palatal Oral Mucosa (POM) Graft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stephen E. Feinberg: lead

Study Sites (1)

University of Michigan, Department of Oral & Maxxillofacial Surgery

Ann Arbor, Michigan, 48109-5018, United States

Location

Results Point of Contact

• Title: Stephen E. Feinberg
• Organization: University of Michigan

sefein@med.umich.edu

734 763 5963

Study Officials

• Stephen E Feinberg, DDS, PhD, MS

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor & Associate Chair of Research

Study Record Dates

• First Submitted: April 12, 2013
• First Posted: April 17, 2013
• Study Start: April 1, 2014
• Primary Completion: January 15, 2019
• Study Completion: January 15, 2019
• Last Updated: September 5, 2021
• Results First Posted: September 5, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)