Gingival Recession
Conditions
Brief 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.
Interventions
DEVICEGintuit
Application of Gintuit at Day 0 to the gingival bed
OTHERAutologous palatal tissue
Tissue will be harvested from the subject's palate and placed on the gingival bed
Sponsors
Organogenesis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With at Least 2 mm Keratinized Tissue (KT) at 6 Months at the Gintuit Treated Site. | 6 months | The superiority of Gintuit relative to a pre-defined standard (50% success) for a 2 mm KT threshold after six months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Texture Same as Adjacent Tissues After 6 Months (Superiority) | 6 months | 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. |
| Percentage of Subjects With at Least 1 mm Keratinized Tissue (KT) at 6 Months at the Gintuit Treated Site. | 6 months | The superiority of Gintuit relative to a pre-defined standard (80% success) for a 1 mm KT threshold after six months. |
| Color Same as Adjacent Tissues After 6 Months (Superiority) | 6 months | 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. |
| Surgical Site Sensitivity Mild or Absent After 1 Week(Superiority) | 6 months | 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. |
| Pain Absent After 3 Days (Superiority) | Day 3 | Pain Assessment(Modified Intent-to-Treat Population) |
| Patient Preference After 6 Months/Early Termination (Superiority) | 6 months | Number of patients expressing preference for Gintuit. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Gintuit and Autologous Free Gingival Graft (FGG) Single application of Gintuit and FGG (control); split-mouth design | 96 |
| Total | 96 |
Baseline characteristics
| Characteristic | Gintuit and Autologous Free Gingival Graft (FGG) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 9 Participants |
| Age, Categorical Between 18 and 65 years | 87 Participants |
| Age Continuous | 47.14 years STANDARD_DEVIATION 13.13 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 85 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 87 Participants |
| Region of Enrollment United States | 96 participants |
| Sex: Female, Male Female | 52 Participants |
| Sex: Female, Male Male | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 96 | 0 / 96 | 0 / 96 | 0 / 96 | 0 / 96 |
| serious Total, serious adverse events | 0 / 96 | 0 / 96 | 0 / 96 | 0 / 96 | 3 / 96 |
Outcome results
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.
Time frame: 6 months
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gintuit | Percentage of Subjects With at Least 2 mm Keratinized Tissue (KT) at 6 Months at the Gintuit Treated Site. | 95.3 percentage of participants |
Comparison: Superiority relative to a pre-defined standard (50% success)p-value: <0.0001Exact Bionomial Test
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.
Time frame: 6 months
Population: See description in primary outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gintuit | Color Same as Adjacent Tissues After 6 Months (Superiority) | Control Not Equally Red as Adjacent Tissue | 56 Participants |
| Gintuit | Color Same as Adjacent Tissues After 6 Months (Superiority) | Control Equally Red as Adjacent Tissue | 23 Participants |
| Gintuit Not Equally Red as Adjacent Tissue | Color Same as Adjacent Tissues After 6 Months (Superiority) | Control Equally Red as Adjacent Tissue | 0 Participants |
| Gintuit Not Equally Red as Adjacent Tissue | Color Same as Adjacent Tissues After 6 Months (Superiority) | Control Not Equally Red as Adjacent Tissue | 6 Participants |
Comparison: Compare participants with (1) Gintuit equally red and Control not equally red to (2) Gintuit not equally red and Control equally redp-value: <0.0001McNemar
Secondary
Pain Absent After 3 Days (Superiority)
Pain Assessment(Modified Intent-to-Treat Population)
Time frame: Day 3
Secondary
Patient Preference After 6 Months/Early Termination (Superiority)
Number of patients expressing preference for Gintuit.
Time frame: 6 months
Population: See description in primary outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gintuit | Patient Preference After 6 Months/Early Termination (Superiority) | 61 participants |
Comparison: The proportion of Gintuit as the preferred procedure.p-value: <0.0001Exact binomial test
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.
Time frame: 6 months
Population: See description in primary outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gintuit | Percentage of Subjects With at Least 1 mm Keratinized Tissue (KT) at 6 Months at the Gintuit Treated Site. | 100 Percentage of Participants |
Comparison: Superiority relative to a pre-defined threshold (80%) successp-value: <0.0001Exact binomial test
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.
Time frame: 6 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gintuit | Surgical Site Sensitivity Mild or Absent After 1 Week(Superiority) | Control Not Sensitive | 67 Participants |
| Gintuit | Surgical Site Sensitivity Mild or Absent After 1 Week(Superiority) | Control Sensitive | 1 Participants |
| Gintuit Not Equally Red as Adjacent Tissue | Surgical Site Sensitivity Mild or Absent After 1 Week(Superiority) | Control Not Sensitive | 3 Participants |
| Gintuit Not Equally Red as Adjacent Tissue | Surgical Site Sensitivity Mild or Absent After 1 Week(Superiority) | Control Sensitive | 0 Participants |
Comparison: Compare participants with (1) Gintuit not sensitive and Control sensitive to (2) Gintuit sensitive and Control not sensitive.p-value: 0.3173McNemar
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.
Time frame: 6 months
Population: See description in primary outcome measures.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gintuit | Texture Same as Adjacent Tissues After 6 Months (Superiority) | Control Equally Firm as Adjacent Tissue | 46 Participants |
| Gintuit | Texture Same as Adjacent Tissues After 6 Months (Superiority) | Control Not Equally Firm as Adjacent Tissue | 35 Participants |
| Gintuit Not Equally Red as Adjacent Tissue | Texture Same as Adjacent Tissues After 6 Months (Superiority) | Control Equally Firm as Adjacent Tissue | 0 Participants |
| Gintuit Not Equally Red as Adjacent Tissue | Texture Same as Adjacent Tissues After 6 Months (Superiority) | Control Not Equally Firm as Adjacent Tissue | 4 Participants |
Comparison: Compare participants with (1)Gintuit equally firm and Control not equally firm to (2) Gintuit not equally firm and Control equally firmp-value: <0.0001McNemar