Expression of Angiogenic Biomarkers During Healing of Intra-Oral Soft Tissue Engineered Grafts

This study has been completed.
Sponsor:
Collaborator:
Organogenesis
Information provided by:
University of Michigan
ClinicalTrials.gov Identifier:
NCT01134081
First received: May 20, 2010
Last updated: May 28, 2010
Last verified: January 2008
  Purpose

The purpose of this research study is to understand more about wound healing of gum tissue. Fluids collected from between a tooth and the gum and directly from wounds contain proteins that occur in different levels as the wound healing process proceeds. In this research study wound fluid will be collected from the donor palate site (roof of your mouth) and the treated sites on your gum before and after placement of CelTx or conventional treatment (tissue from the roof of your mouth) to measure which proteins and how much of each are present during the first 4 weeks of wound healing.


Condition Intervention
Gingival Recession
Biological: CelTx Apligraf

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Official Title: Expression of Angiogenic Biomarkers During Healing of Intra-Oral Soft Tissue Engineered Grafts

Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • The purpose of this study was to investigate the role of angiogenic biomarkers expressed during wound healing using soft tissue engineered material to regenerate intra-oral soft tissue. [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: January 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: CelTx Apligraf
    CelTx™ is a living bilayered cell therapy product. CelTx™ is constructed of Type I bovine collagen (extracted from bovine tendons and subsequently purified) and viable allogeneic human fibroblasts and keratinocytes isolated from human neonatal foreskin. This is applied once in the oral cavity.
Detailed Description:

In a clinical trial designed to evaluate the safety and effectiveness of rhPDGF-BB to promote soft and hard tissue engineering of the periodontium, the subjects provided gingival crevicular fluid (GCF) or periodontal wound fluid (WF) and the results demonstrated contrasting inducible expression patterns of PDGF-AB, VEGF, and ICTP during periodontal healing [17, 24, 25]. However, little is known regarding the release of these molecules into local periodontal wound fluid during tissue-engineered grafts.

The aim of this study is to determine the presence and influence of angiogenic biomarkers, such as PDGF, EGF, HGF, VEGF, KGF, and FGF, involved in the wound healing process of tissue engineered grafts in the treatment of subjects (with recession-type defects) who have an insufficient zone of attached gingival associated with at least two nonadjacent teeth.

3. STUDY OBJECTIVES The purpose of this pilot study is to compare the expression of angiogenic biomarkers involved in the wound healing process of 2 different periodontal surgical approaches: 1) CelTx™ (living bilayered cell therapy product) and 2) free gingival grafts.

3.1 Hypothesis •

Ho: WF levels of angiogenic biomarkers (PDGF-BB, VEGF, FGF, HGF, KGF, EGF, ICAM-1, ANP-1, ANP-2, ANG, IG-10, TIMP-1, TIMP-2) are lower in:

- Areas treated by CelTx™ than treated by free gingival grafts.

Ha: WF levels of angiogenic biomarkers (PDGF-BB, VEGF, FGF, HGF, KGF, EGF, ICAM-1, ANP-1, ANP-2, ANG, IG-10, TIMP-1, TIMP-2) are equal in:

- Areas treated by CelTx™ and free gingival grafts.

Rev 0:

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Once a subject has agreed to participate in the OI CelTx™ Protocol they will undergo a separate informed consent process for this adjunct bio-marker study.

Exclusion Criteria:

  • not a participant in the OI CelTx 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: NCT01134081

Locations
United States, Michigan
Michigan Center for Oral Health Research
Ann Arbor, Michigan, United States, 48106
Sponsors and Collaborators
University of Michigan
Organogenesis
Investigators
Principal Investigator: Rodrigo Neiva, DDS, MS University of Michigan
  More Information

No publications provided by University of Michigan

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rodrigo Neiva, University of Michigan
ClinicalTrials.gov Identifier: NCT01134081     History of Changes
Other Study ID Numbers: 06-PER-002-CTX Bio Adjunct
Study First Received: May 20, 2010
Last Updated: May 28, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Michigan:
gum
recession

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

ClinicalTrials.gov processed this record on July 22, 2014