Gingival RecessionPhase 3NCT00587834
Safety and Efficacy of Gintuit(TM)for Oral Soft Tissue Regeneration
A Phase 3 study testing Gintuit and Autologous palatal tissue in people with Gingival Recession, run by Organogenesis at 4 sites in United States.
Trial summary
The purpose of this study is to evaluate Gintuit as a safe and effective alternative to palatal tissue in the treatment of subjects (with recession-type defects) who have an insufficient zone of attached gingiva associated with at least two nonadjacent teeth. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gingival Recession
- What is being tested?
- Gintuit and Autologous palatal tissue
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 4 sitesUnited States
- Study dates
- Oct 2007to Dec 2008
- Phase
- Phase 3
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is at least 18 years of age but no more than 70 years of age.
- Subject has at least two non-adjacent teeth in contralateral quadrants of the same jaw with an insufficient zone (< or = 1mm) of attached gingiva that requires soft tissue grafting. (1-3 teeth may be treated. In case of adjacent teeth requiring grafting, only one tooth at each site will act as test or control tooth, but all teeth will get the same treatment).
- Root coverage is not desired at the time of grafting.
- Females of childbearing potential must have a documented negative urine pregnancy test.
- Subjects must have read, understood and signed an institutional review board (IRB) approved Informed Consent Form.
- Subjects must be able and willing to follow study procedures and instructions.
Who cannot join
- Subject with class III recession in the presence of a shallow vestibule or class IV recession.
- Subject with vestibule depth of less than 7mm from base of recession.
- Subject with any systemic conditions that could compromise wound healing and preclude periodontal surgery (i.e., diabetes mellitus, cancer, human immunodeficiency virus (HIV), bone metabolic diseases).
- Subject who is currently receiving or has received within two months prior to study entry, systemic corticosteroids, immunosuppressive agents, radiation therapy, and/or chemotherapy which could compromise wound healing and preclude periodontal surgery.
- Subject with the presence of acute infectious lesions in the areas intended for surgery.
- Subject who has used any tobacco product within 3 months.
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- Subject who is taking intramuscular or intravenous bisphosphonates.
- Subject with only molar teeth suitable for soft tissue grafting.
- Subject with teeth that have Miller Grade 2 or higher mobility.
- Subject with known hypersensitivity to bovine collagen and/or iodine (shellfish allergy).
- Subject who has received an investigational drug or biological/bioactive treatment within 30 days prior to study enrollment (medical or dental).
- Subject who was previously treated with Gintuit, Dermagraft or any other skin graft at the target site(s) or immediately adjacent teeth.
- Subject, who in the opinion of the investigator, for any reason other than those listed above, will not be able to complete the study per protocol.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Michigan Center for Oral Health Research
Ann Arbor, Michigan, 48106
Nevins Perio, LLC
Boston, Massachusetts, 02114
Perio Health Professionals, PLLC
Houston, Texas, 77063
University of Texas Health Science Center - San Antonio
San Antonio, Texas, 78229-3900
About this study
Official title: A Clinical Trial to Evaluate Gintuit (TM) (Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen) as an Alternative to Tissue From the Palate to Enhance Oral Soft Tissue Regeneration and Wound Healing
The purpose of this study is to evaluate Gintuit as a safe and effective alternative to palatal tissue in the treatment of subjects (with recession-type defects) who have an insufficient zone of attached gingiva associated with at least two nonadjacent teeth.
- Conditions
- Gingival Recession
- Being tested
- Gintuit, Autologous palatal tissue
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GintuitDevice
Application of Gintuit at Day 0 to the gingival bed
Autologous palatal tissueOther
Tissue will be harvested from the subject's palate and placed on the gingival bed
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Within-subject design: one side of the mouth receives Gintuit Receives: Device: Gintuit |
| 2 | Active comparator | Within-subject control: one side of mouth receives tissue harvested from the palate Receives: Other: Autologous palatal tissue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects With at Least 2 mm Keratinized Tissue (KT) at 6 Months at the Gintuit Treated Site.
The superiority of Gintuit relative to a pre-defined standard (50% success) for a 2 mm KT threshold after six months.
Measured: 6 months
Secondary outcomes (6)
Color Same as Adjacent Tissues After 6 Months (Superiority)
An examiner assessed color of both treated sites compared with the adjacent, non-treated tissue. The assessment was recorded as "More Red", "Equally Red", or "Less Red" as compared to adjacent, non-treated tissue. A match in color with the surrounding tissue is considered a positive aesthetic outcome.
Measured: 6 months
Texture Same as Adjacent Tissues After 6 Months (Superiority)
An examiner assessed texture of both treated sites compared with the adjacent, non-treated tissue. The assessment was recorded as "More Firm", "Equally Firm", or "Less Firm" as compared to adjacent, non-treated tissue. A match in texture with the surrounding tissue is considered a positive aesthetic outcome.
Measured: 6 months
Percentage of Subjects With at Least 1 mm Keratinized Tissue (KT) at 6 Months at the Gintuit Treated Site.
The superiority of Gintuit relative to a pre-defined standard (80% success) for a 1 mm KT threshold after six months.
Measured: 6 months
Patient Preference After 6 Months/Early Termination (Superiority)
Number of patients expressing preference for Gintuit.
Measured: 6 months
Surgical Site Sensitivity Mild or Absent After 1 Week(Superiority)
The sensitivity of Gintuit, Free Gingival Graft (FGG) and palatal donation sites was assessed with a puff of air and rated by the Investigator as none, mild, moderate or severe sensitivity. The sensitivity of Control was determined as the most sensitive of FGG and palatal donation sites.
Measured: 6 months
Pain Absent After 3 Days (Superiority)
Pain Assessment(Modified Intent-to-Treat Population)
Measured: Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2008 (estimated)
- Study startOct 2007
- Primary completionDec 2008
- Study completionDec 2008
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organogenesis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael McGuire, DDS, Principal investigator, Perio Health Professionals, PLLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00587834
- Sponsor's protocol ID
- 06-PER-002-CTX
- Status last verified
- Oct 2012
- First submitted
- 21 Dec 2007
- Last updated
- 8 Nov 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
McGuire MK, Scheyer ET, Nevins ML, Neiva R, Cochran DL, Mellonig JT, Giannobile WV, Bates D. Living cellular construct for increasing the width of keratinized gingiva: results from a randomized, within-patient, controlled trial. J Periodontol. 2011 Oct;82(10):1414-23. doi: 10.1902/jop.2011.100671. Epub 2011 Mar 29.
PubMed 21513473
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Evaluate Gintuit (TM) (Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen) as an Alternative to Tissue From the Palate to Enhance Oral Soft Tissue Regeneration and Wound Healing
- ClinicalTrials.gov ID
- NCT00587834
- Acronym / sponsor ID
- 06-PER-002-CTX
- Conditions
- Gingival Recession
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- OrganogenesisIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 7 Jan 2008 (estimated)
- Results
- Posted 8 Nov 2012
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 Gintuit as a safe and effective alternative to palatal tissue in the treatment of subjects (with recession-type defects) who have an insufficient zone of attached gingiva associated with at least two nonadjacent teeth.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: GintuitWithin-subject design: one side of the mouth receives Gintuit |
| 2 | Active comparator | Other: Autologous palatal tissueWithin-subject control: one side of mouth receives tissue harvested from the palate |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject is at least 18 years of age but no more than 70 years of age.
- Subject has at least two non-adjacent teeth in contralateral quadrants of the same jaw with an insufficient zone (< or = 1mm) of attached gingiva that requires soft tissue grafting. (1-3 teeth may be treated. In case of adjacent teeth requiring grafting, only one tooth at each site will act as test or control tooth, but all teeth will get the same treatment).
- Root coverage is not desired at the time of grafting.
- Females of childbearing potential must have a documented negative urine pregnancy test.
- Subjects must have read, understood and signed an institutional review board (IRB) approved Informed Consent Form.
Key exclusion criteria (13 listed)
- Subject with class III recession in the presence of a shallow vestibule or class IV recession.
- Subject with vestibule depth of less than 7mm from base of recession.
- Subject with any systemic conditions that could compromise wound healing and preclude periodontal surgery (i.e., diabetes mellitus, cancer, human immunodeficiency virus (HIV), bone metabolic diseases).
- Subject who is currently receiving or has received within two months prior to study entry, systemic corticosteroids, immunosuppressive agents, radiation therapy, and/or chemotherapy which could compromise wound healing and preclude periodontal surgery.
- Subject with the presence of acute infectious lesions in the areas intended for surgery.
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 |
|---|---|---|
| GintuitApplication of Gintuit at Day 0 to the gingival bed | Device | 1 |
| Autologous palatal tissueTissue will be harvested from the subject's palate and placed on the gingival bed | Other | 2 |
Primary outcome
Percentage of Subjects With at Least 2 mm Keratinized Tissue (KT) at 6 Months at the Gintuit Treated Site.
Time frame: 6 months
The superiority of Gintuit relative to a pre-defined standard (50% success) for a 2 mm KT threshold after six months.
6 secondary outcomes
Color Same as Adjacent Tissues After 6 Months (Superiority)
Time frame: 6 months
Texture Same as Adjacent Tissues After 6 Months (Superiority)
Time frame: 6 months
Percentage of Subjects With at Least 1 mm Keratinized Tissue (KT) at 6 Months at the Gintuit Treated Site.
Time frame: 6 months
Patient Preference After 6 Months/Early Termination (Superiority)
Time frame: 6 months
Surgical Site Sensitivity Mild or Absent After 1 Week(Superiority)
Time frame: 6 months
Pain Absent After 3 Days (Superiority)
Time frame: Day 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21513473McGuire MK, Scheyer ET, Nevins ML, Neiva R, Cochran DL, Mellonig JT, Giannobile WV, Bates D. Living cellular construct for increasing the width of keratinized gingiva: results from a randomized, within-patient, controlled trial. J Periodontol. 2011 Oct;82(10):1414-23. doi: 10.1902/jop.2011.100671. Epub 2011 Mar 29.
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i-PRF-Based Bioactive Matrix vs. Connective Tissue Graft in the Treatment of Gingival Recessions
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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.
Michael McGuire, DDS principal investigator
Perio Health Professionals, PLLC
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gintuit and Autologous palatal tissue in people with Gingival Recession, run by Organogenesis at 4 sites 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 6 inclusion and 13 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 8 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Yes. Results are posted in the registry (first posted 8 Nov 2012). 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?
Percentage of Subjects With at Least 2 mm Keratinized Tissue (KT) at 6 Months at the Gintuit Treated Site. (time frame: 6 months). 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 NCT00587834, 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 8 Nov 2012.