A Pilot Study of CelTx (Apligraf®)* in the Treatment of Gingival Recession Requiring Root Coverage - Full Text View

Sponsored by:	Organogenesis
Information provided by:	Organogenesis
ClinicalTrials.gov Identifier:	NCT00679081

Purpose

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.

Condition	Intervention	Phase
Gingival Recession	Device: CelTx Device: autologous subepithelial connective tissue graft	Phase I Phase II

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety Study
Official Title:	A Prospective, Randomized, Controlled Pilot Study of CelTx (Apligraf®)* as an Alternative to Tissue From the Palate in the Treatment of Gingival Recession Requiring Root Coverage

Further study details as provided by Organogenesis:

Primary Outcome Measures:

To assess the safety of CelTx in the treatment of gingival recession requiring root coverage [ Time Frame: 6-month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Periodontal Health Measures [ Time Frame: 6-months ] [ Designated as safety issue: No ]
Aesthetic Measures [ Time Frame: 6-months ] [ Designated as safety issue: No ]
Post-Surgical Subject Comfort Measures [ Time Frame: 4-weeks ] [ Designated as safety issue: No ]
Subject Preference Measures [ Time Frame: 6-months ] [ Designated as safety issue: No ]

Estimated Enrollment:	26
Study Start Date:	May 2008
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Single-application of CelTx	Device: CelTx single application
B: Active Comparator Autologous sub-epithelial connective tissue graft	Device: autologous subepithelial connective tissue graft autologous subepithelial connective tissue graft

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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).
Test tooth has < 20% plaque according to the modified O'Leary Plaque Index.
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 no soft tissue loss interproximally.
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 periodontal pockets in area of treatment.
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 skin graft 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00679081

Contacts

Contact: Margo McKinlay

781-401-1184

mmckinlay@organo.com

Locations

United States, Texas
Perio Health Professionals, PLLC	Recruiting
Houston, Texas, United States, 77063
Contact: Rebecca Garcia 713-783-5442 rebeccag@periohealth.com
Principal Investigator: Micheal McGuire, DDS

Sponsors and Collaborators

Organogenesis

Investigators

Principal Investigator:

Michael McGuire, DDS

Perio Health Professionals, PLLC

More Information

Responsible Party:	Organogenesis Inc. ( Katherine B. Giovino )
Study ID Numbers:	07-PER-004-CTX
Study First Received:	May 14, 2008
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00679081
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Mouth Diseases
Periodontal Diseases
Gingival Diseases
Gingival Recession
Stomatognathic Diseases

ClinicalTrials.gov processed this record on January 15, 2009