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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Within-subject design: one side of the mouth receives Gintuit |
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| 2 | Active Comparator | Within-subject control: one side of mouth receives tissue harvested from the palate |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gintuit | Device | Application of Gintuit at Day 0 to the gingival bed |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael McGuire, DDS | Perio Health Professionals, PLLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nevins Perio, LLC | Boston | Massachusetts | 02114 | United States | ||
| Michigan Center for Oral Health Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21513473 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Gintuit and Autologous Free Gingival Graft (FGG) | Single application of Gintuit and FGG (control); split-mouth design |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Gintuit and Autologous Free Gingival Graft (FGG) | Single application of Gintuit and FGG (control); split-mouth design |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Per protocol the first 2 subjects per Investigator were training subjects and evaluated for safety only. There were 11 training subjects and the remaining 85 subjects were analyzed for all efficacy outcomes. | Posted | Number | 95% Confidence Interval | percentage of participants | 6 months |
|
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6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Gintuit | Adverse events occurring at the Gintuit treated site |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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Secondary outcome measures were tested with a closed testing strategy; therefore pain was not tested (no p-value) because previous endpoint (site sensitivity) failed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Operations | Organogenesis Inc. | 781-575-0775 | clinical@organo.com |
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| ID | Term |
|---|---|
| D005889 | Gingival Recession |
| ID | Term |
|---|---|
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| Autologous palatal tissue |
| Other |
Tissue will be harvested from the subject's palate and placed on the gingival bed |
|
| 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. | 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. | 6 months |
| Patient Preference After 6 Months/Early Termination (Superiority) | Number of patients expressing preference for Gintuit. | 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. | 6 months |
| Pain Absent After 3 Days (Superiority) | Pain Assessment(Modified Intent-to-Treat Population) | Day 3 |
| Ann Arbor |
| Michigan |
| 48106 |
| United States |
| Perio Health Professionals, PLLC | Houston | Texas | 77063 | United States |
| University of Texas Health Science Center - San Antonio | San Antonio | Texas | 78229-3900 | United States |
| Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Participants |
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| Secondary | 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. | See description in primary outcome measure. | Posted | Number | Participants | 6 months |
|
|
|
|
| Secondary | 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. | See description in primary outcome measures. | Posted | Number | Participants | 6 months |
|
|
|
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| Secondary | 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. | See description in primary outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of Participants | 6 months |
|
|
|
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| Secondary | Patient Preference After 6 Months/Early Termination (Superiority) | Number of patients expressing preference for Gintuit. | See description in primary outcome measure. | Posted | Number | 95% Confidence Interval | participants | 6 months |
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| Secondary | 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. | See description in primary outcome measures. The presence of Coe-Pak (protective periodontal dressing) at Week 1 prohibited the assessment of sensitivity for 14 subjects. The analysis was performed on 71 of the 85 subjects evaluated for efficacy. | Posted | Number | Participants | 6 months |
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| Secondary | Pain Absent After 3 Days (Superiority) | Pain Assessment(Modified Intent-to-Treat Population) | Not Posted | Number | Participants | Day 3 |
| 0 |
| 96 |
| 0 |
| 96 |
| EG001 | Free Gingival Graft | Adverse events occurring at the autologous free gingival graft site | 0 | 96 | 0 | 96 |
| EG002 | Palatal Donation Site | Adverse events occurring at the palatal donation site | 0 | 96 | 0 | 96 |
| EG003 | Mouth | Adverse events occurring in the mouth and not localized to the Gintuit, FGG, or palatal donation sites. | 0 | 96 | 0 | 96 |
| EG004 | Other | Adverse events occurring at any other location in the body or systemic conditions | 3 | 96 | 0 | 96 |
| Chest Pains | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Malignant Metastatic Fibrous Histiocytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
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The sponsor can review communications prior to public release and can embargo communications regarding trial results for at least 30 days in advance of public release. The sponsor can request removal of any confidential or proprietary information provided by sponsor and extend such review period for another 90 days to file patent applications or take other steps to protect the sponsor's intellectual property interests.
| D055093 |
| Periodontal Atrophy |