Expression of Angiogenic Biomarkers During Healing of Intra-Oral Soft Tissue Engineered Grafts
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.
|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|
- 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 ]
|Study Start Date:||January 2008|
|Study Completion Date:||December 2008|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
Biological: CelTx Apligraf
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01134081
|United States, Michigan|
|Michigan Center for Oral Health Research|
|Ann Arbor, Michigan, United States, 48106|
|Principal Investigator:||Rodrigo Neiva, DDS, MS||University of Michigan|