At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Expression of Angiogenic Biomarkers During Healing of Intra-Oral Soft Tissue Engineered Grafts
In Brief
A clinical study evaluating CelTx™ and Free Gingival Graft for Gingival Recession. Completed, enrolled 44 participants across 1 site.
Detailed 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.
Study Details
Timeline
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.
Harvested tissue from palate