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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01134081
First Posted: May 31, 2010
Last Update Posted: August 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Organogenesis
Information provided by (Responsible Party):
William Giannobile, University of Michigan
  Purpose
The purpose of this observational research study is to understand more about wound healing of gum tissue. This study was the biomarker study of a small cohort of study participants derived from NCT01547962 (completed). Two surgical sites of each patient were randomly selected to receive CelTx™ as a donor material in one site and conventional autograft using keratinized tissue from the palate as the donor material at the contralateral (opposite side) site. 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 and 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™ Procedure: Free Gingival Graft

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Expression of Angiogenic Biomarkers During Healing of Intra-Oral Soft Tissue Engineered Grafts

Further study details as provided by William Giannobile, University of Michigan:

Primary Outcome Measures:
  • Differences in Angiogenic Biomarkers [ Time Frame: 5 time-points: pre-surgical, week(s) 1, 2, 3 and 4 ]
    Within-subject difference between the concentrations at the CelTX and Free Gingival Graft areas

  • Differences in Angiogenic Biomarkers: PDGF-BB [ Time Frame: 5 time-points: pre-surgical, week(s) 1, 2, 3 and 4 ]
    Within-subject difference between the concentrations at the CelTX and Free Gingival Graft areas


Enrollment: 44
Study Start Date: January 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CelTx™
Living bilayered cell therapy product
Biological: CelTx™
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.
Active Comparator: Free Gingival Grafts
Harvested tissue from palate
Procedure: Free Gingival Graft
Harvested tissue from palate

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, VEGF, 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.

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject has signed informed consent to participate in Organogenesis Clinical Protocol 06-PER-002-CTX.
  • Subject has signed informed consent to participate in this adjunct bio-marker study.
  • Subject is willing to comply with the additional study visits at weeks 2 and 3 as required by this study.

Exclusion Criteria:

- Subject requires antibiotic prophylaxis for routine dental procedures.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
Responsible Party: William Giannobile, Chair, Department of Periodontics & Oral Medicine Najjar Endowed Professor of Dentistry and Biomedical Engineering, University of Michigan
ClinicalTrials.gov Identifier: NCT01134081     History of Changes
Other Study ID Numbers: 06-PER-002-CTX Bio Adjunct
First Submitted: May 20, 2010
First Posted: May 31, 2010
Results First Submitted: September 27, 2010
Results First Posted: July 18, 2017
Last Update Posted: August 21, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by William Giannobile, University of Michigan:
gum
recession

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