N/A
N=44
Expression of Angiogenic Biomarkers During Healing of Intra-Oral Soft Tissue Engineered Grafts
Gingival Recession
Bottom Line
View on ClinicalTrials.gov: NCT01134081 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcome: Primary: Differences in Angiogenic Biomarkers — 0.51; .69; 1.04; .67 ng/mL
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CelTx™ (Biological); Free Gingival Graft (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Differences in Angiogenic Biomarkers |
0.51; .69; 1.04; .67; .28; .16 | — |
| PRIMARY Differences in Angiogenic Biomarkers: PDGF-BB |
10.59; 9.73; 51.82; 28.92; 4.50; 2.33 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01134081). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.