Status:
TERMINATED
A Pilot Study of CelTx(TM) (Apligraf®) in the Treatment of Gingival Recession Requiring Root Coverage
Lead Sponsor:
Organogenesis
Conditions:
Gingival Recession
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
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 anti...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00679081
Start Date
May 1 2008
End Date
September 1 2010
Last Update
January 11 2012
Active Locations (1)
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1
Perio Health Professionals, PLLC
Houston, Texas, United States, 77063