Mandibular InjuriesPhase 2NCT01834339
EVPOME Versus AlloDerm in Subjects Reconstructed With Large Defect Mandibular Resection
A Phase 2 study testing AlloDerm and EVPOME in people with Mandibular Injuries, run by Stephen E. Feinberg at 1 site in United States.
Trial summary
The purpose of this study is to compare the safety and effectiveness of performing oral reconstructive surgeries using either AlloDerm, a product commonly used for this purpose, or AlloDerm that has been overlaid with the subject's oral mucosal cells and developed into a type of graft that is called an ex vivo… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mandibular Injuries
- What is being tested?
- AlloDerm and EVPOME
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Dec 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Be an adult over 18 years of age
- Have a free fibular graft placed more than six months ago that has been used for restoration of mandibular continuity.
- Be in need of surgery to increase the vestibular fold of the grafted mandible for placement of a dental prosthesis to restore function
Who cannot join
- Any liver, kidney, heart, blood, metabolic or systemic disease which may make execution of the protocol of interpretation of the results difficult
- A history of syphilis, HIV, Hepatitis B or Hepatitis C
- Pregnancy or planning to become pregnant
- Known or suspected allergy to bovine (cow) protein
- Receiving radiation
- Currently smoking or using tobacco products
Show all 9Show fewer
- Talking medication that can result in gingival enlargement (Cyclosporine, Dilantin, calcium channel blockers)
- Allergy to any of the following antibiotics Gentamycin, Cefoxitin, Lincomycin, Polymyxin B, Vancomycin, cephalosporins, or clindamycin
- Allergy to Polysorbate 20
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Parallel-Group (Autogenous EVPOME Versus AlloDerm Without Incorporation of Keratinocytes) Study in Subjects Reconstructed With Large Defect Mandibular Resection in Need of Vestibuloplasty for Dental Rehabilitation
The purpose of this study is to compare the safety and effectiveness of performing oral reconstructive surgeries using either AlloDerm, a product commonly used for this purpose, or AlloDerm that has been overlaid with the subject's oral mucosal cells and developed into a type of graft that is called an ex vivo produced oral mucosal equivalent, EVPOME.
- Conditions
- Mandibular Injuries
- Being tested
- AlloDerm, EVPOME
- Keywords
- vestibuloplasty
- Medical subject headings
- Mandibular Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlloDermBiological
EVPOMEBiological
| Study group | Role | What they receive |
|---|---|---|
| AlloDerm | Active comparator | The subject will be treated with the standard of care, AlloDerm, to cover the defect in the mouth. Receives: Biological: AlloDerm |
| EVPOME | Experimental | An ex-vivo produced oral mucose equivalent (EVPOME) will be used to cover the defect in the top of the mouth. Receives: Biological: EVPOME |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Graft Contracture
During surgery, after preparation of the recipient bed, the recipient bed and the graft will be measured for the maximum distance between non-resorbable sutures placed at the margins of the graft. Post-surgical measurements of the graft site will be taken at visits 5, 6, 7, and 8 and compared to original graft size to assess percentage of graft contracture.
Measured: 2-24 weeks
Secondary outcomes (2)
Degree of Epithelialized Tissue
Degree of epithelialized mucosa will be assessed by biopsy taken at the geometric center of the graft at week 4 s/p grafting. The biopsy will be evaluated by routine histology for the presence of an intact and stratified keratinized epithelial layer and by immunohistochemistry (IHC) for microvessel vascular ingrowth into the dermis/dermal matrix (AlloDerm).
Measured: 4 weeks after surgery
Laser Doppler Flowmetry (LDF)
LDF measurements will be used to assess graft blood flow (tissue perfusion of the grafts). The LDF measures will also be compared with the immunohistochemistry (IHC) results seen on the biopsy to determine the relationship between the flood flow and degree of microvessel infiltration into the dermis/dermal matrix (AlloDerm) based on the two measures.
Measured: Visit 1 and 2 and 4 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 startSep 2013
- Primary completionNov 2014
- Study completionDec 2015
Why it stopped: Loss of cGMP facility to manufacture product used in clinical trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mandibular InjuriesStudies 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
- 1 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 Feinberg, DDS, MS, PhD, Principal investigator, Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01834339
- Sponsor's protocol ID
- HUM00069761
- Status last verified
- Nov 2017
- First submitted
- 12 Apr 2013
- Last updated
- 22 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Parallel-Group (Autogenous EVPOME Versus AlloDerm Without Incorporation of Keratinocytes) Study in Subjects Reconstructed With Large Defect Mandibular Resection in Need of Vestibuloplasty for Dental Rehabilitation
- ClinicalTrials.gov ID
- NCT01834339
- Acronym / sponsor ID
- HUM00069761
- Conditions
- Mandibular Injuries
- Keywords
- vestibuloplasty
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Loss of cGMP facility to manufacture product used in clinical trial.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Stephen E. FeinbergUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 17 Apr 2013 (estimated)
- Results
- Not posted in the source record
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 compare the safety and effectiveness of performing oral reconstructive surgeries using either AlloDerm, a product commonly used for this purpose, or AlloDerm that has been overlaid with the subject's oral mucosal cells and developed into a type of graft that is called an ex vivo produced oral mucosal equivalent, EVPOME.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AlloDerm | Active comparator | Biological: AlloDermThe subject will be treated with the standard of care, AlloDerm, to cover the defect in the mouth. |
| EVPOME | Experimental | Biological: EVPOMEAn ex-vivo produced oral mucose equivalent (EVPOME) will be used to cover the defect in the top of the mouth. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Be an adult over 18 years of age
- Have a free fibular graft placed more than six months ago that has been used for restoration of mandibular continuity.
- Be in need of surgery to increase the vestibular fold of the grafted mandible for placement of a dental prosthesis to restore function
Key exclusion criteria (9 listed)
- Any liver, kidney, heart, blood, metabolic or systemic disease which may make execution of the protocol of interpretation of the results difficult
- A history of syphilis, HIV, Hepatitis B or Hepatitis C
- Pregnancy or planning to become pregnant
- Known or suspected allergy to bovine (cow) protein
- Receiving radiation
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 |
|---|---|---|
| AlloDerm | Biological | AlloDerm |
| EVPOME | Biological | EVPOME |
Primary outcome
Percent Graft Contracture
Time frame: 2-24 weeks
During surgery, after preparation of the recipient bed, the recipient bed and the graft will be measured for the maximum distance between non-resorbable sutures placed at the margins of the graft. Post-surgical measurements of the graft site will be taken at visits 5, 6, 7, and 8 and compared to original graft size to assess percentage of graft contracture.
2 secondary outcomes
Degree of Epithelialized Tissue
Time frame: 4 weeks after surgery
Laser Doppler Flowmetry (LDF)
Time frame: Visit 1 and 2 and 4 weeks after surgery
Results and safety
The study was stopped early (reason given: Loss of cGMP facility to manufacture product used in clinical trial.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2017.
- Individual participant dataSharing planned: No
Related trials for Mandibular Injuries
Recruiting
Optimized Osteosynthesis: Bone Mineral Density Recovery in Mandibular Body Fractures Using Patient-Specific Versus Conventional Plates
Mandibular Fractures
Active, not recruiting
Fixation of Mandibular Angle Fracture Using 3D Titanium Miniplate Versus Standard Two Plate Fixation
Mandible Fracture, Force Measurement
Not yet recruiting
Antibacterial Effect and Soft Tissue Healing of Chlorhexidine-Coated Polyglactin 910 Sutures After Impacted Lower Third Molar Surgery
Impacted Third Molar Tooth, Surgical Wound Healing
Recruiting
Custom-Made Titanium Plates Versus Custom-Made Polyether Ether Ketone (PEEK) Plates
Mandibular Fractures
Recruiting
Dynamic Contrast-Enhanced Magnetic Resonance Imaging in Diagnosing Osteoradionecrosis in Patients With Head and Neck Cancer That Is Primary, Has Come Back, or Has Spread to Other Places in the Body
Head and Neck Cancer
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 Feinberg, DDS, MS, PhD principal investigator
Faculty
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 AlloDerm and EVPOME in people with Mandibular Injuries, 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 9 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 22 Nov 2017. 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?
The study was stopped early (reason given: Loss of cGMP facility to manufacture product used in clinical trial.). Results are not available in the source record.
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?
Percent Graft Contracture (time frame: 2-24 weeks). 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 22 Nov 2017.