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| Name | Class |
|---|---|
| Organogenesis | INDUSTRY |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CelTx™ | Experimental | Living bilayered cell therapy product |
|
| Free Gingival Grafts | Active Comparator | Harvested tissue from palate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
- Subject requires antibiotic prophylaxis for routine dental procedures.
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| Name | Affiliation | Role |
|---|---|---|
| Rodrigo Neiva, DDS, MS | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Michigan Center for Oral Health Research | Ann Arbor | Michigan | 48106 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21248359 | Result | 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. |
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44 subjects were enrolled. All 44 subjects participated in both arms/groups for a total of 88 surgical sites. 2 surgical sites of each patient were randomly selected to receive LCC as a donor material in 1 site and a conventional autograft using keratinized tissue from the palate as the donor material at the contralateral site.
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| ID | Title | Description |
|---|---|---|
| FG000 | CelTx™ & Free Gingival Grafts | CelTx™: Living bilayered cell therapy product Free Gingival Grafts: Harvested tissue from palate |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CelTx™ & Free Gingival Grafts | CelTx™: Living bilayered cell therapy product Free Gingival Grafts: Harvested tissue from palate |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Differences in Angiogenic Biomarkers | Within-subject difference between the concentrations at the CelTX and Free Gingival Graft areas | 44 subjects were enrolled. All 44 subjects participated in both arms/groups for a total of 88 surgical sites. 2 surgical sites of each patient were randomly selected to receive LCC as a donor material in 1 site and a conventional autograft using keratinized tissue from the palate as the donor material at the contralateral site. | Posted | Mean | Standard Error | ng/mL | 5 time-points: pre-surgical, week(s) 1, 2, 3 and 4 | Surgical sites | Surgical sites |
|
6 months
No adverse or serious adverse events were observed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CelTx™ | Living bilayered cell therapy product |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. William Giannobile | University of Michigan | 734 763 2105 | wgiannob@umich.edu |
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| ID | Term |
|---|---|
| D005889 | Gingival Recession |
| ID | Term |
|---|---|
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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|
| Free Gingival Graft | Procedure | Harvested tissue from palate |
|
| Surgical sites |
|
| years |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants | Participants |
|
Harvested tissue from palate
|
|
| Primary | Differences in Angiogenic Biomarkers: PDGF-BB | Within-subject difference between the concentrations at the CelTX and Free Gingival Graft areas | 44 subjects were enrolled. All 44 subjects participated in both arms/groups for a total of 88 surgical sites. 2 surgical sites of each patient were randomly selected to receive LCC as a donor material in 1 site and a conventional autograft using keratinized tissue from the palate as the donor material at the contralateral site. | Posted | Mean | Standard Error | pg/mL | 5 time-points: pre-surgical, week(s) 1, 2, 3 and 4 |
|
|
|
| 0 |
| 44 |
| 0 |
| 44 |
| EG001 | Free Gingival Graft | Harvested tissue from palate | 0 | 44 | 0 | 44 |
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| D055093 |
| Periodontal Atrophy |
| Week 2 |
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| Week 3 |
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| Week 4 |
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