Localized Gingival RecessionPhase 1NCT02657395
Root Coverage Using a Xenograph for Treatment of Gingival Recession
A Phase 1 study testing PriMatrix in people with Localized Gingival Recession, run by Mayo Clinic at 1 site in United States.
Trial summary
Can a fetal bovine derived membrane serve as an alternative to autogenous tissue for dental root coverage procedures. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Localized Gingival Recession
- What is being tested?
- PriMatrix
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to Jun 2017
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults 18-90 years of age
- Miller Class I \& II defects on maxillary or mandibular teeth
- At least 1 adjacent non-involved tooth on either side of the included recession defects
- Keratinized tissue width of ≥2.0 mm
- Periodontal probing depths of 3 mm or on included teeth
- Plaque index of 2 or less
Show all 9Show fewer
- Bleeding on probing at 30% or less sites
- Current non-smoker
- No active infected wounds
Who cannot join
- Patients less than 18 years of age
- Miller Class III, or IV mucogingival defects
- Miller Class I \& II defects without adjacent non-involved teeth
- CEJ not identifiable
- Root surface restoration at the defect site
- Periodontal probing depths greater than 3 mm
Show all 27Show fewer
- Plaque index of 2 or greater
- Bleeding on probing at more than 30% of sites
- Uncontrolled oral disease
- Moderate to severe generalized chronic or aggressive periodontitis
- Oral manifestations of a systemic disease
- History of previous root coverage procedure, graft, or GTR
- Current smoker or other tobacco use
- Alcohol abuse problems
- Traumatic occlusion impinging on the recession defect
- Use of intraoral appliances that impinge on the recession defect
- Intra-oral piercings that impinge on the included defect
- Uncontrolled systemic health conditions
- Debilitating systemic or infectious disease
- Diabetes
- Heart Disease
- Uncontrolled heart disease
- Delayed wound healing
- Immunocompromised status due to medication or immune system dysfunction
- Active infection or non-healing wounds
- Currently pregnant or lactating
- Long-term steroid use
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 Utilization to Achieve Dental Root Coverage
Can a fetal bovine derived membrane serve as an alternative to autogenous tissue for dental root coverage procedures.
Read the detailed description
PriMatrix (TEI Medical Inc) is a promising collagen membrane derived from fetal bovine dermis. The acellular porous structure of the membrane permits rapid re-vascularization and cellular re-population. The membrane contains a high proportion of type III collagen. Type III collagen helps regulate tissue healing by promoting neoepithelialization and angiogenesis. Wounds grafted with PriMatrix exhibited significantly faster healing rates compared to control wounds while having a minimal foreign body response and early repopulation by progenitor cells.
The ability of PriMatrix to permit neovascularization, reepithelialization, minimal immune response, and population by progenitor cells suggests that it may serve as an ideal alternative to CTG under CPF for root coverage. In this regard, the current study aims to serve as a pilot to test the feasibility of the use of PriMatrix as a graft material under a CPF to attain root coverage of Miller Class I \& II defects.
- Conditions
- Localized Gingival Recession
- Being tested
- PriMatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PriMatrixDevice
Use of PriMatrix under a coronal positioned flap to obtain root coverage.
| Study group | Role | What they receive |
|---|---|---|
| PriMatrix | Experimental | Use of PriMatrix as a substitute for a subepithelial connective tissue graft under a coronal positioned flap for root coverage. Receives: Device: PriMatrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Root Coverage
The percentage of sites showing complete root coverage will be calculated as a percent of treated defects with the marginal gingival located at or above the cement-enamel junction compared to the total defects treated.
Measured: 6-months
Secondary outcomes (9)
Clinical Periodontal Parameters
Determine keratinized tissue width of the augmented region using a UNC-15 mm periodontal probe.
Measured: Baseline, 6-weeks, 4-months, and 6-months
Clinical Periodontal Parameters
Determine periodontal probing depths of the augmented region using a UNC-15 mm periodontal probe.
Measured: Baseline, 6-weeks, 4-months, and 6-months
Clinical Periodontal Parameters
Determine tissue thickness of the augmented region using a UNC-15 mm periodontal probe.
Measured: Baseline, 6-weeks, 4-months, and 6-months
Clinical Periodontal Parameters
Determine clinical attachment levels of the augmented region using a UNC-15 mm periodontal probe.
Measured: Baseline, 6-weeks, 4-months, and 6-months
Pain Levels
Visual analog scale questionnaire will be completed consisting of 5 to 6 questions at each appointment.
Measured: 1-week, 2-weeks, 4-weeks, and 6-months
Mean Root Coverage Obtained
Percentage of baseline root coverage obtained as a fraction of initial recession depth will be measured using a UNC-15 mm periodontal probe.
Measured: Baseline, 6-weeks, 4-months, and 6-months
Gingival Health
Gingival health will be evaluated visually using Silness and Loe Gingival index.
Measured: Baseline, 6-weeks, 4-months, and 6-months
Plaque Levels
Plaque levels will be evaluated using the Quigley and Hein plaque index.
Measured: Baseline, 6-weeks, 4-months, and 6-months
Esthetic Outcomes
Visual analog scale questionnaire will be completed consisting of 5 to 6 questions at each appointment.
Measured: 1-week, 2-weeks, 4-weeks, and 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2016 (estimated)
- Study startOct 2015
- Primary completionJun 2017
- Study completionJun 2017
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.
- More trials run by Mayo ClinicThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Bovine collagen matrix -PriMatrix
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Assad, Mayo Clinic
- Investigators
- Daniel Assad, DDS, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02657395
- Sponsor's protocol ID
- 15-006568
- Status last verified
- Jul 2017
- First submitted
- 16 Dec 2015
- Last updated
- 25 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PriMatrix Utilization to Achieve Dental Root Coverage
- ClinicalTrials.gov ID
- NCT02657395
- Acronym / sponsor ID
- 15-006568
- Conditions
- Localized Gingival Recession
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 15 Jan 2016 (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.
Can a fetal bovine derived membrane serve as an alternative to autogenous tissue for dental root coverage procedures.
Detailed description
PriMatrix (TEI Medical Inc) is a promising collagen membrane derived from fetal bovine dermis. The acellular porous structure of the membrane permits rapid re-vascularization and cellular re-population. The membrane contains a high proportion of type III collagen. Type III collagen helps regulate tissue healing by promoting neoepithelialization and angiogenesis. Wounds grafted with PriMatrix exhibited significantly faster healing rates compared to control wounds while having a minimal foreign body response and early repopulation by progenitor cells.
The ability of PriMatrix to permit neovascularization, reepithelialization, minimal immune response, and population by progenitor cells suggests that it may serve as an ideal alternative to CTG under CPF for root coverage. In this regard, the current study aims to serve as a pilot to test the feasibility of the use of PriMatrix as a graft material under a CPF to attain root coverage of Miller Class I \& II defects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Bovine collagen matrix -PriMatrix
| Arm | Type | Receives |
|---|---|---|
| PriMatrix | Experimental | Device: PriMatrixUse of PriMatrix as a substitute for a subepithelial connective tissue graft under a coronal positioned flap for root coverage. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
Key exclusion criteria (27 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 |
|---|---|---|
| PriMatrixUse of PriMatrix under a coronal positioned flap to obtain root coverage. | Device | PriMatrix |
Primary outcome
Complete Root Coverage
Time frame: 6-months
The percentage of sites showing complete root coverage will be calculated as a percent of treated defects with the marginal gingival located at or above the cement-enamel junction compared to the total defects treated.
9 secondary outcomes
Clinical Periodontal Parameters
Time frame: Baseline, 6-weeks, 4-months, and 6-months
Clinical Periodontal Parameters
Time frame: Baseline, 6-weeks, 4-months, and 6-months
Clinical Periodontal Parameters
Time frame: Baseline, 6-weeks, 4-months, and 6-months
Clinical Periodontal Parameters
Time frame: Baseline, 6-weeks, 4-months, and 6-months
Pain Levels
Time frame: 1-week, 2-weeks, 4-weeks, and 6-months
Mean Root Coverage Obtained
Time frame: Baseline, 6-weeks, 4-months, and 6-months
Gingival Health
Time frame: Baseline, 6-weeks, 4-months, and 6-months
Plaque Levels
Time frame: Baseline, 6-weeks, 4-months, and 6-months
Esthetic Outcomes
Time frame: 1-week, 2-weeks, 4-weeks, and 6-months
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 25 Jul 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Localized Gingival Recession
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Free Soft Tissue Grafts (FSTG) Using Autograft Palatal Donor Tissue vs. Xenograft Collagen Matrix (Zderm™)
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Palatal Wound Healing After Free Gingival Graft Harvest in Diabetic Patients: A Clinical Trial
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Evaluation of the Effect of Smoking on Palatal Donor Site Tissue Profile in the Success of Connective Tissue Grafts
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Oral Mucosa Wound Healing After Gingival Recession Treatment in Diabetic Patients. A Clinical Study.
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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
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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.
Daniel Assad, 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 PriMatrix in people with Localized Gingival Recession, run by Mayo Clinic 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 9 inclusion and 27 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 25 Jul 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 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?
Complete Root Coverage (time frame: 6-months). 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 25 Jul 2017.