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

NCT ID: NCT00679081

Last Updated: 2012-01-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2010-09-30

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.

Conditions

Gingival Recession

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CelTx

CelTx

Group Type: EXPERIMENTAL

CelTx

Intervention Type: DEVICE

Single application; split-mouth design

Autologous CTG

Autologous sub-epithelial connective tissue graft

Group Type: ACTIVE_COMPARATOR

Autologous sub-epithelial connective tissue graft

Intervention Type: OTHER

Single application; split-mouth design

Interventions

CelTx

Single application; split-mouth design

Intervention Type: DEVICE

Autologous sub-epithelial connective tissue graft

Single application; split-mouth design

Intervention Type: OTHER

Eligibility 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).
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organogenesis

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael McGuire, DDS

Role: PRINCIPAL_INVESTIGATOR

Perio Health Professionals, PLLC

Locations

Perio Health Professionals, PLLC

Houston, Texas, United States

Countries

United States

Other Identifiers

07-PER-004-CTX

Identifier Type: -

Identifier Source: org_study_id