Facial NeoplasmsPhase 3NCT00123097
Clinical Trial of New Elastomer for Maxillofacial Prosthetics
A Phase 3 study testing Chlorinated polyethylene elastomer in people with Facial Neoplasms and Head and Neck Neoplasms, run by University of Louisville at 1 site in United States.
Trial summary
The purpose of this study is to evaluate a new rubber material used to make prosthetic replacements of the face lost to cancer, trauma, or birth defects. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Facial Neoplasms, Head and Neck Neoplasms, Head Injuries, Penetrating
- What is being tested?
- Chlorinated polyethylene elastomer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2005to Aug 2009
- Phase
- Phase 3
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Requires treatment for developmental or acquired extraoral facial defect
- Fully healed wound (6 months after surgery and/or radiation)
- Defect no larger than 9 x 12 cm (3.5 x 4.5 inches, the diameter of a giant bronze flask)
- Cognizant enough to answer questionnaires
- Agrees to wear the prosthesis at least 6 hours per day
- Agrees to use the prescribed adhesive (Epithane-3 - now called Daro Adhesive Extra Strength) and clean and store as instructed
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- Plans to be able to return to the research institution for a 10 month period
- Able to manage prosthesis him/herself or with caregiver for a 10 month period
- Karnofsky score greater than or equal to 60 (www.hospicepatients.org/karnofsky.html)
- No framework or implant/magnet retention
- No multiple recurrences of tumor
- No hypersensitivity to adhesives or test materials
- No current systemic or topical facial steroid treatment
- Not legally blind
- Not expected to have further surgeries to defect, radiation therapy, or other cytoreductive therapy over the next 10 months
- No evidence of active skin condition/disease
- Not an infectious risk patient
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Louisville
Louisville, Kentucky, 40292-0001
About this study
Official title: Multicenter Trial of CPE for Maxillofacial Prosthetics
The purpose of this study is to evaluate a new rubber material used to make prosthetic replacements of the face lost to cancer, trauma, or birth defects.
Read the detailed description
Maxillofacial prosthetics is a subspecialty of prosthodontics, providing the clinical rehabilitation treatment of patients who have lost parts of the face due to cancer, trauma, or birth defects. It is an orphan field that:
- treats few patients, making the subspecialty unprofitable for manufacturers to develop new materials;
- offers fundamental rehabilitation and improvement in the quality of life to patients who may have exhausted personal or third party funding; and
- provides a dental solution to an essentially medical problem.
Silicone rubber materials have been used for facial rehabilitation for more than 4 decades with few improvements. There is a clear need for new, alternative, and more economic materials for extraoral maxillofacial prostheses. Research at Gulf South Research Institute in New Orleans by the Principal Investigator and others in the 1970s and 1980s developed an alternative low-cost thermoplastic industrial rubber material (chlorinated polyethylene, CPE) that met all toxicological (safety) and physical (effectiveness) requirements. A Phase 2 clinical trial at the time yielded equivocal results when compared to conventional but costly silicone rubber products.
This research is a controlled, randomized, single-crossover, double-blinded investigator-initiated multicenter Phase 3 clinical trial treating 100 patients that evaluates:
- experimental thermoplastic CPE; and
- control silicone (Silastic Adhesive A/MDX4-4210) materials for non-inferiority of CPE based on functional and subjective characteristics, and on the quality of life.
The clinical centers of the trial are at M.D. Anderson Cancer Center in Houston, Texas, and at the Toronto Sunnybrook Regional Cancer Centre in Toronto, Canada.
- Being tested
- Chlorinated polyethylene elastomer
- Keywords
- Facial Neoplasms, Head and Neck Neoplasms, Head Injuries, Penetrating, Birth Injuries
- Medical subject headings
- Facial Neoplasms, Head and Neck Neoplasms, Head Injuries, Penetrating, Birth Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorinated polyethylene elastomerCombination product
Also called CPE
Chlorinated polyethylene
| Study group | Role | What they receive |
|---|---|---|
| Chlorinated polyethylene elastomer first | Experimental | Patient receives prosthetic made from CPE then the SOC, silicon. Receives: Combination Product: Chlorinated polyethylene elastomer |
| Silicon first | Active comparator | Patient receives prosthetic made from the SOC, silicon, followed by the CPE,Chlorinated polyethylene elastomer. Receives: Combination Product: Chlorinated polyethylene elastomer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-inferiority of chlorinated polyethylene elastomer (CPE) material
Measured: 10 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2005 (estimated)
- Study startFeb 2005
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Facial NeoplasmsStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Principal investigator, Lawrence M. Gettleman, DMD, MSD, University of Louisville
- Investigators
- Sudarat Kiat-amnuay, DDS MS, Study chair, University of Texas Dental BranchMark S Chambers, DMD MS, Study chair, MD Anderson Cancer Center, Dept. of Head & Neck SurgeryJames D Anderson, DDS MScD, Principal investigator, Toronto Sunnybrook Regional Cancer CentreLawrence Gettleman, DMD, MSD, Principal investigator, University of Louisville, School of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00123097
- Sponsor's protocol ID
- NIDCR-14543
- Other IDs
- U01DE014543, 5U01DE014543
- Status last verified
- Apr 2017
- First submitted
- 21 Jul 2005
- Last updated
- 7 Apr 2017
- Results posted
- No
Publications
Kiat-amnuay S, Jacob RF, Chambers MS, Anderson JD, Sheppard RA, Johnston DA, Haugh GS, Gettleman L. Clinical trial of chlorinated polyethylene for facial prosthetics. Int J Prosthodont. 2010 May-Jun;23(3):263-70.
PubMed 20552094
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Trial of CPE for Maxillofacial Prosthetics
- ClinicalTrials.gov ID
- NCT00123097
- Acronym / sponsor ID
- NIDCR-14543
- Keywords
- Facial Neoplasms, Head and Neck Neoplasms, Head Injuries, Penetrating, Birth Injuries
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- Feb 2005
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 22 Jul 2005 (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 evaluate a new rubber material used to make prosthetic replacements of the face lost to cancer, trauma, or birth defects.
Detailed description
Maxillofacial prosthetics is a subspecialty of prosthodontics, providing the clinical rehabilitation treatment of patients who have lost parts of the face due to cancer, trauma, or birth defects. It is an orphan field that:
- treats few patients, making the subspecialty unprofitable for manufacturers to develop new materials;
- offers fundamental rehabilitation and improvement in the quality of life to patients who may have exhausted personal or third party funding; and
- provides a dental solution to an essentially medical problem.
Silicone rubber materials have been used for facial rehabilitation for more than 4 decades with few improvements. There is a clear need for new, alternative, and more economic materials for extraoral maxillofacial prostheses. Research at Gulf South Research Institute in New Orleans by the Principal Investigator and others in the 1970s and 1980s developed an alternative low-cost thermoplastic industrial rubber material (chlorinated polyethylene, CPE) that met all toxicological (safety) and physical (effectiveness) requirements. A Phase 2 clinical trial at the time yielded equivocal results when compared to conventional but costly silicone rubber products.
This research is a controlled, randomized, single-crossover, double-blinded investigator-initiated multicenter Phase 3 clinical trial treating 100 patients that evaluates:
- experimental thermoplastic CPE; and
- control silicone (Silastic Adhesive A/MDX4-4210) materials for non-inferiority of CPE based on functional and subjective characteristics, and on the quality of life.
The clinical centers of the trial are at M.D. Anderson Cancer Center in Houston, Texas, and at the Toronto Sunnybrook Regional Cancer Centre in Toronto, Canada.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chlorinated polyethylene elastomer first | Experimental | Combination Product: Chlorinated polyethylene elastomerPatient receives prosthetic made from CPE then the SOC, silicon. |
| Silicon first | Active comparator | Combination Product: Chlorinated polyethylene elastomerPatient receives prosthetic made from the SOC, silicon, followed by the CPE,Chlorinated polyethylene elastomer. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Requires treatment for developmental or acquired extraoral facial defect
- Fully healed wound (6 months after surgery and/or radiation)
- Defect no larger than 9 x 12 cm (3.5 x 4.5 inches, the diameter of a giant bronze flask)
- Cognizant enough to answer questionnaires
- Agrees to wear the prosthesis at least 6 hours per day
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Chlorinated polyethylene elastomerAlso: CPEChlorinated polyethylene | Combination product | Chlorinated polyethylene elastomer first, Silicon first |
Primary outcome
Non-inferiority of chlorinated polyethylene elastomer (CPE) material
Time frame: 10 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2017.
- Derived from this study: PubMed 20552094Kiat-amnuay S, Jacob RF, Chambers MS, Anderson JD, Sheppard RA, Johnston DA, Haugh GS, Gettleman L. Clinical trial of chlorinated polyethylene for facial prosthetics. Int J Prosthodont. 2010 May-Jun;23(3):263-70.
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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.
Sudarat Kiat-amnuay, DDS MS study chair
University of Texas Dental Branch
Mark S Chambers, DMD MS study chair
MD Anderson Cancer Center, Dept. of Head & Neck Surgery
James D Anderson, DDS MScD principal investigator
Toronto Sunnybrook Regional Cancer Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Chlorinated polyethylene elastomer in people with Facial Neoplasms and Head and Neck Neoplasms, run by University of Louisville 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 17 inclusion and 0 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: finished, as of the sponsor's last update on 7 Apr 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Non-inferiority of chlorinated polyethylene elastomer (CPE) material (time frame: 10 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00123097, which also lists 1 linked publication.
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 7 Apr 2017.