Disorder of Oral Mucous MembranePhase 2NCT01834326
Phase II Clinical Trial of Intraoral Grafting of Human Tissue Engineered Oral Mucosa
A Phase 2 study testing EVPOME (autogenous ex vivo produced oral mucosa equivalent) and POM (Palatal oral mucosa) in people with Disorder of Oral Mucous Membrane, run by Stephen E. Feinberg at 1 site in United States.
Trial summary
The purpose of this study is to improve the current standard of care of repairing mouth soft tissue defects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Disorder of Oral Mucous Membrane
- What is being tested?
- EVPOME (autogenous ex vivo produced oral mucosa equivalent) and POM (Palatal oral mucosa)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to 15 Jan 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan, Department of Oral & Maxxillofacial Surgery
Ann Arbor, Michigan, 48109-5018
About this study
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
The purpose of this study is to improve the current standard of care of repairing mouth soft tissue defects.
Read the 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.
- Conditions
- Disorder of Oral Mucous Membrane
- Being tested
- EVPOME (autogenous ex vivo produced oral mucosa equivalent), POM (Palatal oral mucosa)
- Keywords
- dental implants, deficient keratinized oral mucosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
POM (Palatal oral mucosa)Biological
POM is a tissue graft harvested from the palate and surgically placed into the defect area
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Biological: EVPOME (autogenous ex vivo produced oral mucosa equivalent) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 and 4 weeks post surgical graft
Secondary outcomes (1)
Graft Contracture
Graft measurements collected at each time point post graft surgery, 2 weeks, 4 weeks, 8 weeks and 24 weeks. Measurements collected, Horizontal Coronal (mm), Horizontal Apical (mm), Vertical between coronal and apical (mm), were used to determine the area of the graft as a trapezoid like shape. The area of the graft at each time point was compared to the area of the graft at the time of implantation (graft surgery) to determine the % of graft contracture from implantation thru each follow-up time point. Less graft contracture is considered a better outcome.
Measured: 2, 4, 8 and 24 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2013 (estimated)
- Study startApr 2014
- Primary completion15 Jan 2019
- Study completion15 Jan 2019
Why it stopped: The funding period for the study ended. The study did not reach full enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Disorder of Oral Mucous MembraneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stephen E. Feinberg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Stephen E. Feinberg, University of Michigan
- Investigators
- Stephen E Feinberg, DDS, PhD, MS, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01834326
- Sponsor's protocol ID
- HUM00065554
- Status last verified
- Aug 2021
- First submitted
- 12 Apr 2013
- Last updated
- 5 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01834326
- Acronym / sponsor ID
- HUM00065554
- Conditions
- Disorder of Oral Mucous Membrane
- Keywords
- dental implants, deficient keratinized oral mucosa
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The funding period for the study ended. The study did not reach full enrollment.
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Stephen E. FeinbergUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- 15 Jan 2019 (actual)
- Study completion
- 15 Jan 2019 (actual)
- First posted
- 17 Apr 2013 (estimated)
- Results
- Posted 5 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to improve the current standard of care of repairing mouth soft tissue defects.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Palatal Oral Mucosa (POM) Graft | Active comparator | Biological: POM (Palatal oral mucosa)Standard of care palatal oral mucosa (POM) graft will be taken from the palate and then surgically placed onto the defect area |
| Ex vivo Produced Oral Mucosa Equivalent | Experimental | Biological: EVPOME (autogenous 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Biological | Ex vivo Produced Oral Mucosa Equivalent |
| POM (Palatal oral mucosa)POM is a tissue graft harvested from the palate and surgically placed into the defect area | Biological | Palatal Oral Mucosa (POM) Graft |
Primary outcome
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. 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.
1 secondary outcome
Graft Contracture
Time frame: 2, 4, 8 and 24 weeks after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen E Feinberg, DDS, PhD, MS principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EVPOME (autogenous ex vivo produced oral mucosa equivalent) and POM (Palatal oral mucosa) in people with Disorder of Oral Mucous Membrane, run by Stephen E. Feinberg at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Increase in Zone (Width) of Keratinized Mucosa at Grafted Site (time frame: 2 and 4 weeks post surgical graft). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2021.