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Completed

NCT Number: NCT01134081

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

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.

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Key information

Conditions

Gingival Recession Gingival Diseases Mouth Diseases Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Michigan Center for Oral Health Research

Ann Arbor, Michigan, 48106, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CelTx™

Biological

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.

Free gingival graft

Procedure

Harvested tissue from palate

Primary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Organogenesis

Registry information

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
May 31, 2010
Registry last updated
Aug 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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