Localized Gingival RecessionPhase 1NCT02206009
Use of a Collagen Membrane for Soft Tissue Grafting
A Phase 1 study testing Collagen Membrane in people with Localized Gingival Recession, run by Lauren M. F. Syrowik at 1 site in United States.
Trial summary
Is PriMatrix wound dressing capable of regenerating gum tissue inside the mouth? Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Localized Gingival Recession
- What is being tested?
- Collagen Membrane
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Dec 2015
- Phase
- Phase 1
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must have one to three consecutive teeth with recession and less than 1 mm of keratinized gingiva
Who cannot join
- Asthma
- Pregnancy
- Uncontrolled diabetes
- Use of continuous positive airway pressure (CPAP) machine for sleep apnea
- Oral appliances (removable partial dentures, braces, mandibular advancement, bruxism splints, etc.)
- Tobacco use
- Immunocompromised individual
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: PriMatrix Dermal Repair Scaffold Utilization Intraorally
Is PriMatrix wound dressing capable of regenerating gum tissue inside the mouth?
Read the detailed description
PriMatrix is an acellular fetal bovine dermal matrix that has a wide array of FDA approved uses. These uses include partial- and full-thickness wounds, pressure, diabetic, and venous ulcers, surgical wounds, trauma wounds, tunneled wounds, and draining wounds. It is a sheet-like matrix made up primarily of type I and type III collagen. An increased proportion of type III collagen appears to play a key role in healing and regeneration.
The use of extracellular dermal matrices is a relatively young field, and the exact mechanism by which PriMatrix promotes skin regeneration is still unknown. Despite this, PriMatrix has demonstrated differences in manufacturing and molecular composition that make it conducive to the harsh environments in which it has already been tested. Intraorally, where there is a rich vascular bed, this material holds exceeding promise.
Utilizing this vascularity, autogenous free gingival grafts from the palate have already had their efficacy proven as a method of augmenting the keratinized tissue.The need to increase the keratinized tissue is based upon the postulation that less mobile, keratinized epithelium is more resilient than the non-keratinized oral mucosa. This is especially important in areas where recession and attachment loss has already occurred. Without having keratinized gingiva apical to the recession area, it has been suggested that there is a greater risk for more attachment loss to occur, thus reducing the support for the tooth. In addition, autogenous free gingival grafts have demonstrated the phenomenon of "creeping attachment" where a portion of the recession actually becomes covered as a result of grafting.
While autogenous grafting is the gold standard in soft tissue augmentation, the amount of tissue that can be taken from the palate is limited, making it difficult to treat patients with generalized recession. Furthermore, a secondary surgical site increases the morbidity associated with the procedure. The hypothesis of this study is that PriMatrix will be able to provide similar results to an autogenous free gingival graft.
- Conditions
- Localized Gingival Recession
- Being tested
- Collagen Membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collagen MembraneDevice
Also called PriMatrix
First, the recipient site is prepared, and the collagen membrane hydrated. The collagen membrane is sutured firmly against the prepared vascular bed with a long-lasting suture material. The subject is requested to minimize the amount of manipulation to the area to maintain graft stability.
| Study group | Role | What they receive |
|---|---|---|
| Collagen membrane | Experimental | First, the recipient site is prepared, and the collagen membrane hydrated. The collagen membrane is sutured firmly against the prepared vascular bed with a long-lasting suture material. The subject is requested to minimize the amount of manipulation to the area to maintain graft stability. Receives: Device: Collagen Membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in depth of keratinized tissue
The amount of gingival augmentation will be assessed by the depth of keratinized tissue, measured in millimeters. Change in the amount of keratinized tissue in the areas of interest from baseline to 6 months will be tested to see if they are statistically significant.
Measured: baseline, approximately 6 months after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2014 (estimated)
- Study startJul 2014
- Primary completionSep 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Localized Gingival RecessionStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lauren M. F. Syrowik
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lauren M. F. Syrowik, Mayo Clinic
- Investigators
- Daniel Assad, DDS, Study director, Mayo ClinicLauren MF Syrowik, DDS, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02206009
- Sponsor's protocol ID
- 14-000767
- Status last verified
- Jan 2016
- First submitted
- 30 Jul 2014
- Last updated
- 6 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PriMatrix Dermal Repair Scaffold Utilization Intraorally
- ClinicalTrials.gov ID
- NCT02206009
- Acronym / sponsor ID
- 14-000767
- Conditions
- Localized Gingival Recession
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Lauren M. F. SyrowikUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 1 Aug 2014 (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.
Is PriMatrix wound dressing capable of regenerating gum tissue inside the mouth?
Detailed description
PriMatrix is an acellular fetal bovine dermal matrix that has a wide array of FDA approved uses. These uses include partial- and full-thickness wounds, pressure, diabetic, and venous ulcers, surgical wounds, trauma wounds, tunneled wounds, and draining wounds. It is a sheet-like matrix made up primarily of type I and type III collagen. An increased proportion of type III collagen appears to play a key role in healing and regeneration.
The use of extracellular dermal matrices is a relatively young field, and the exact mechanism by which PriMatrix promotes skin regeneration is still unknown. Despite this, PriMatrix has demonstrated differences in manufacturing and molecular composition that make it conducive to the harsh environments in which it has already been tested. Intraorally, where there is a rich vascular bed, this material holds exceeding promise.
Utilizing this vascularity, autogenous free gingival grafts from the palate have already had their efficacy proven as a method of augmenting the keratinized tissue.The need to increase the keratinized tissue is based upon the postulation that less mobile, keratinized epithelium is more resilient than the non-keratinized oral mucosa. This is especially important in areas where recession and attachment loss has already occurred. Without having keratinized gingiva apical to the recession area, it has been suggested that there is a greater risk for more attachment loss to occur, thus reducing the support for the tooth. In addition, autogenous free gingival grafts have demonstrated the phenomenon of "creeping attachment" where a portion of the recession actually becomes covered as a result of grafting.
While autogenous grafting is the gold standard in soft tissue augmentation, the amount of tissue that can be taken from the palate is limited, making it difficult to treat patients with generalized recession. Furthermore, a secondary surgical site increases the morbidity associated with the procedure. The hypothesis of this study is that PriMatrix will be able to provide similar results to an autogenous free gingival graft.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Collagen membrane | Experimental | Device: Collagen MembraneFirst, the recipient site is prepared, and the collagen membrane hydrated. The collagen membrane is sutured firmly against the prepared vascular bed with a long-lasting suture material. The subject is requested to minimize the amount of manipulation to the area to maintain graft stability. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Must have one to three consecutive teeth with recession and less than 1 mm of keratinized gingiva
Key exclusion criteria (7 listed)
- Asthma
- Pregnancy
- Uncontrolled diabetes
- Use of continuous positive airway pressure (CPAP) machine for sleep apnea
- Oral appliances (removable partial dentures, braces, mandibular advancement, bruxism splints, etc.)
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 |
|---|---|---|
| Collagen MembraneAlso: PriMatrixFirst, the recipient site is prepared, and the collagen membrane hydrated. The collagen membrane is sutured firmly against the prepared vascular bed with a long-lasting suture material. The subject is requested to minimize the amount of manipulation to the area to maintain graft stability. | Device | Collagen membrane |
Primary outcome
Change in depth of keratinized tissue
Time frame: baseline, approximately 6 months after the procedure
The amount of gingival augmentation will be assessed by the depth of keratinized tissue, measured in millimeters. Change in the amount of keratinized tissue in the areas of interest from baseline to 6 months will be tested to see if they are statistically significant.
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 6 Jan 2016.
Related trials for Localized Gingival Recession
Not yet recruiting
Free Soft Tissue Grafts (FSTG) Using Autograft Palatal Donor Tissue vs. Xenograft Collagen Matrix (Zderm™)
Gingival Recession Localized Moderate, Dental Implant
Recruiting
Palatal Wound Healing After Free Gingival Graft Harvest in Diabetic Patients: A Clinical Trial
Diabetes Mellitus, Gingival Recession, Generalized
Not yet recruiting
Evaluation of the Effect of Smoking on Palatal Donor Site Tissue Profile in the Success of Connective Tissue Grafts
Soft Tissue Augmentation, Gingival Recession Localized Moderate
Not yet recruiting
Oral Mucosa Wound Healing After Gingival Recession Treatment in Diabetic Patients. A Clinical Study.
Diabetes Mellitus, Gingival Recession, Generalized
Not yet recruiting
Clinical and Histological Evaluation of Subepithelial Connective Tissue Graft Maturation at Different Healing Timepoints, With and Without Topical Application of a Polynucleotide- and Hyaluronic Acid-Based Gel
Gingival Recession, Generalized, Gingival Recession, Localized
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.
Daniel Assad, DDS study director
Mayo Clinic
Lauren MF Syrowik, DDS principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Collagen Membrane in people with Localized Gingival Recession, run by Lauren M. F. Syrowik 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 1 inclusion and 7 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 6 Jan 2016. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Change in depth of keratinized tissue (time frame: baseline, approximately 6 months after the procedure). 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 6 Jan 2016.