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

Gingival Recession Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01134081
• Other study ID #: 06-PER-002-CTX Bio Adjunct
• Status: Completed
• Phase: N/A
• First received: May 20, 2010
• Last updated: May 28, 2010
• Start date: January 2008
• Est. completion date: December 2008

Study information

• Verified date: January 2008
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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:

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gingival Recession

Intervention

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.

Locations

Country	Name	City	State
United States	Michigan Center for Oral Health Research	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Organogenesis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		one year	No