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.
- 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
- 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.
- 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
- 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
- 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
- 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
- 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
- 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