Clinical trial NCT01134081: Expression of Angiogenic Biomarkers During Healing of Intra-Oral Soft Tissue Engineered Grafts
Official title: Expression of Angiogenic Biomarkers During Healing of Intra-Oral Soft Tissue Engineered Grafts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Recession
Keywords: gum
recession
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Organogenesis
First posted: 2010-05-31
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

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 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.

Primary outcomes:
measure: Differences in Angiogenic Biomarkers
timeFrame: 5 time-points: pre-surgical, week(s) 1, 2, 3 and 4
measure: Differences in Angiogenic Biomarkers: PDGF-BB
timeFrame: 5 time-points: pre-surgical, week(s) 1, 2, 3 and 4
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Michigan Center for Oral Health Research
state: Michigan
Study officials:
affiliation: University of Michigan
name: Rodrigo Neiva, DDS, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Morelli T, Neiva R, Nevins ML, McGuire MK, Scheyer ET, Oh TJ, Braun TM, Nor JE, Bates D, Giannobile WV. Angiogenic biomarkers and healing of living cellular constructs. J Dent Res. 2011 Apr;90(4):456-62. doi: 10.1177/0022034510389334. Epub 2011 Jan 19.