Trials / Completed
CompletedNCT00587834
Safety and Efficacy of Gintuit(TM)for Oral Soft Tissue Regeneration
A Clinical Trial to Evaluate Gintuit (TM) (Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen) as an Alternative to Tissue From the Palate to Enhance Oral Soft Tissue Regeneration and Wound Healing
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 96 (actual)
- Sponsor
- Organogenesis · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate Gintuit as a safe and effective alternative to palatal tissue in the treatment of subjects (with recession-type defects) who have an insufficient zone of attached gingiva associated with at least two nonadjacent teeth.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Gintuit | Application of Gintuit at Day 0 to the gingival bed |
| OTHER | Autologous palatal tissue | Tissue will be harvested from the subject's palate and placed on the gingival bed |
Timeline
- Start date
- 2007-10-01
- Primary completion
- 2008-12-01
- Completion
- 2008-12-01
- First posted
- 2008-01-07
- Last updated
- 2012-11-08
- Results posted
- 2012-11-08
Locations
4 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00587834. Inclusion in this directory is not an endorsement.