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

Completed · Not applicable

Conditions studied: Gingival Recession

In brief

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.

Key facts

Study ID

NCT01134081

Run by

University of Michigan

People needed

44

Starts

2008-01-01

Expected to finish

2008-12-01

Last updated by the study team

2017-08-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Michigan Center for Oral Health Research — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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