A Pilot Study of CelTx(TM) (Apligraf®) in the Treatment of Gingival Recession Requiring Root Coverage

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective, Randomized, Controlled Pilot Study of CelTx(TM) (Apligraf®) as an Alternative to Tissue From the Palate in the Treatment of Gingival Recession Requiring Root Coverage

Conditions
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Gingival Recession

Intervention / Treatment
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* Device: CelTx
* Other: Autologous sub-epithelial connective tissue graft


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CelTx<br>CelTx | Device: CelTx<br>* Single application; split-mouth design<br>|
| Active Comparator: Autologous CTG<br>Autologous sub-epithelial connective tissue graft | Other: Autologous sub-epithelial connective tissue graft<br>* Single application; split-mouth design<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6-month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Periodontal Health Measures |  | 6-months | 
| Aesthetic Measures |  | 6-months | 
| Post-Surgical Subject Comfort Measures |  | 4-weeks | 
| Subject Preference Measures |  | 6-months |