Trials / Terminated
TerminatedNCT00679081
A Pilot Study of CelTx(TM) (Apligraf®) in the Treatment of Gingival Recession Requiring Root Coverage
A Prospective, Randomized, Controlled Pilot Study of CelTx(TM) (Apligraf®) as an Alternative to Tissue From the Palate in the Treatment of Gingival Recession Requiring Root Coverage
- Status
- Terminated
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 15 (actual)
- Sponsor
- Organogenesis · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate CelTx as an alternative to tissue from the palate in the treatment of subjects with Miller Class I or II recession defects who desire root coverage. It is anticipated that this study will demonstrate that CelTx is a safe alternative to palatal tissue and demonstrate potential to enhance oral soft tissue regeneration and wound healing.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | CelTx | Single application; split-mouth design |
| OTHER | Autologous sub-epithelial connective tissue graft | Single application; split-mouth design |
Timeline
- Start date
- 2008-05-01
- Primary completion
- 2010-09-01
- Completion
- 2010-09-01
- First posted
- 2008-05-16
- Last updated
- 2012-01-11
- Results posted
- 2011-11-21
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00679081. Inclusion in this directory is not an endorsement.