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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Organogenesis
ClinicalTrials.gov Identifier:
NCT00679081
First received: May 14, 2008
Last updated: January 9, 2012
Last verified: January 2012
  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
Other: Autologous sub-epithelial connective tissue graft
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Organogenesis:

Primary Outcome Measures:
  • Overall Rate of Adverse Events (AEs) [ Time Frame: 6-month ] [ Designated as safety issue: Yes ]

    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.



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 ]

Enrollment: 15
Study Start Date: May 2008
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CelTx
CelTx
Device: CelTx
Single application; split-mouth design
Active Comparator: Autologous CTG
Autologous sub-epithelial connective tissue graft
Other: Autologous sub-epithelial connective tissue graft
Single application; split-mouth design

  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).
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Texas
Perio Health Professionals, PLLC
Houston, Texas, United States, 77063
Sponsors and Collaborators
Organogenesis
Investigators
Principal Investigator: Michael McGuire, DDS Perio Health Professionals, PLLC
  More Information

No publications provided

Responsible Party: Organogenesis
ClinicalTrials.gov Identifier: NCT00679081     History of Changes
Other Study ID Numbers: 07-PER-004-CTX
Study First Received: May 14, 2008
Results First Received: October 10, 2011
Last Updated: January 9, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Gingival Recession
Gingival Diseases
Mouth Diseases
Periodontal Atrophy
Periodontal Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on November 27, 2014