Gingival Recession
Conditions
Brief summary
The purpose of this study is to evaluate CelTx as an alternative to tissue from the palate in the treatment of subjects with Miller Class I or II recession defects who desire root coverage. It is anticipated that this study will demonstrate that CelTx is a safe alternative to palatal tissue and demonstrate potential to enhance oral soft tissue regeneration and wound healing.
Interventions
DEVICECelTx
Single application; split-mouth design
OTHERAutologous sub-epithelial connective tissue graft
Single application; split-mouth design
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 Miller Class I or II buccal recession (≥ 3 mm) that requires soft tissue grafting. (Teeth may be treated with a maximum difference of 2 mm with respect to depth and width). * Females of childbearing potential must have a documented negative urine pregnancy test and must agree to continue acceptable methods of contraception for 6 months post surgery. * Subjects must have read, understood and signed an institutional review board (IRB)-approved Informed Consent Form (ICF). * Subjects must be able and willing to follow study procedures and instructions.
Exclusion criteria
* Subject has extremely prominent root surfaces (\> 1/2 the diameter of the root facial to cortical plate). * Subject has interproximal attachment loss beyond the CEJ. * Subject with teeth that have a Miller Grade 2 or higher mobility. * Subjects with Class V restorations. * Subjects with crowns on the teeth selected for treatment. * Subjects who have had endodontic therapy in the last 6 months on the teeth selected for treatment. * Subjects who have used any tobacco product within the past 3 months. * Subjects with only molar teeth suitable for soft tissue grafting. * Subject has probing pocket depth \>/= 4 mm at either surgical site. * Female subjects who are pregnant or lactating. * Subjects with any systemic conditions (i.e., uncontrolled diabetes mellitus, cancer, HIV, bone metabolic diseases) that could compromise wound healing and preclude periodontal surgery. * Subjects who are currently receiving or have 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. * Subjects with the presence of acute infectious lesions. * Subjects taking intramuscular or intravenous bisphosphonates. * Subjects with a known hypersensitivity to bovine collagen and/or iodine (shellfish allergy). * Subjects who have received an investigational drug, device or biological/bioactive treatment within 30 days prior to study enrollment (medical or dental). * Subjects previously treated with Apligraf/CelTx, Dermagraft or any other cell-based product, including autologous tissue at the target site(s) or immediately adjacent teeth. * Subjects, 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 |
|---|---|---|
| Overall Rate of Adverse Events (AEs) | 6-month | Adverse events were collected at every visit throughout the 6 month duration. An AE is defined as any adverse change in the subject's medical status when compared with the subject's baseline condition, whether or not the event is related to the study device or a study procedure; or an exacerbation (either in frequency or severity) in a subject's pre-existing condition. |
Secondary
| Measure | Time frame |
|---|---|
| Post-Surgical Subject Comfort Measures | 4-weeks |
| Subject Preference Measures | 6-months |
| Aesthetic Measures | 6-months |
| Periodontal Health Measures | 6-months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CelTx and Autologous CTG; Split-mouth Design Enrolled subjects had 2 non-adjacent teeth in contralateral quadrants of the same jaw identified and randomized to treatment with CelTx or autologous sub-epithelial connective tissue graft (CTG). Either a folded or a single layer of CelTx or autologous sub-epithelial CTG was applied to the teeth selected for treatment according to the randomization scheme; only 1 tooth was treated per quadrant. The harvested autologous sub-epithelial CTG was shaped to fit the recipient site and was similar in size to CelTx. Surgical site preparation and CelTx and autologous sub-epithelial CTG placement were the same for both treatment sites. | 15 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | CelTx and Autologous CTG; Split-mouth Design |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants |
| Age Continuous | 42.5 years STANDARD_DEVIATION 11 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 participants |
| Race/Ethnicity, Customized Asian | 3 participants |
| Race/Ethnicity, Customized Black or African American | 0 participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 participants |
| Race/Ethnicity, Customized Other | 0 participants |
| Race/Ethnicity, Customized White | 12 participants |
| Region of Enrollment United States | 15 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 2 / 15 | 2 / 15 | 8 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 | 0 / 15 |
Outcome results
Primary
Overall Rate of Adverse Events (AEs)
Adverse events were collected at every visit throughout the 6 month duration. An AE is defined as any adverse change in the subject's medical status when compared with the subject's baseline condition, whether or not the event is related to the study device or a study procedure; or an exacerbation (either in frequency or severity) in a subject's pre-existing condition.
Time frame: 6-month
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CelTx Site | Overall Rate of Adverse Events (AEs) | 2 participants |
| Graft Site | Overall Rate of Adverse Events (AEs) | 2 participants |
| Other Location | Overall Rate of Adverse Events (AEs) | 8 participants |
Secondary
Aesthetic Measures
Time frame: 6-months
Secondary
Periodontal Health Measures
Time frame: 6-months
Secondary
Post-Surgical Subject Comfort Measures
Time frame: 4-weeks
Secondary
Subject Preference Measures
Time frame: 6-months