Expression of Angiogenic Biomarkers During Healing of Intra-Oral Soft Tissue Engineered Grafts
1 other identifier
interventional
44
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 20, 2010
CompletedFirst Posted
Study publicly available on registry
May 31, 2010
CompletedResults Posted
Study results publicly available
July 18, 2017
CompletedAugust 21, 2017
June 1, 2017
11 months
May 20, 2010
September 27, 2010
July 19, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Differences in Angiogenic Biomarkers
Within-subject difference between the concentrations at the CelTX and Free Gingival Graft areas
5 time-points: pre-surgical, week(s) 1, 2, 3 and 4
Differences in Angiogenic Biomarkers: PDGF-BB
Within-subject difference between the concentrations at the CelTX and Free Gingival Graft areas
5 time-points: pre-surgical, week(s) 1, 2, 3 and 4
Study Arms (2)
CelTx™
EXPERIMENTALLiving bilayered cell therapy product
Free Gingival Grafts
ACTIVE COMPARATORHarvested tissue from palate
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- \- Subject requires antibiotic prophylaxis for routine dental procedures.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Michiganlead
- Organogenesiscollaborator
Study Sites (1)
Michigan Center for Oral Health Research
Ann Arbor, Michigan, 48106, United States
Related Publications (1)
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.
PMID: 21248359RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Although the present study compared the differences in angiogenic biomarker expression between LCC and autograft, it is important to understand that both LCC and autograft heal by two different healing processes.
Results Point of Contact
- Title
- Dr. William Giannobile
- Organization
- University of Michigan
Study Officials
- PRINCIPAL INVESTIGATOR
Rodrigo Neiva, DDS, MS
University of Michigan
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chair, Department of Periodontics & Oral Medicine Najjar Endowed Professor of Dentistry and Biomedical Engineering
Study Record Dates
First Submitted
May 20, 2010
First Posted
May 31, 2010
Study Start
January 1, 2008
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
August 21, 2017
Results First Posted
July 18, 2017
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will not share