Phase II Clinical Trial of Intraoral Grafting of Human Tissue Engineered Oral Mucosa
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|ClinicalTrials.gov Identifier: NCT01834326|
Recruitment Status : Active, not recruiting
First Posted : April 17, 2013
Last Update Posted : November 30, 2018
|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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- Graft contracture [ Time Frame: 2, 4, 8 and 24 weeks after surgery ]
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT01834326
|United States, Michigan|
|University of Michigan, Department of Oral & Maxxillofacial Surgery|
|Ann Arbor, Michigan, United States, 48109-5018|
|Principal Investigator:||Stephen E Feinberg, DDS, PhD, MS||University of Michigan|