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NCT00587834 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Gintuit(TM)for Oral Soft Tissue Regeneration
A Phase 3 study, sponsored by Organogenesis.
- Completed
- Registry status
- Phase 3
- Development phase
- 96
- Enrollment target
NCT00587834: Completed Phase 3 study, sponsored by Organogenesis.
NCT00587834 is a Phase 3 study that has completed, run by Organogenesis. The registered enrollment target is 96 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00587834, a Phase 3 study, has completed, sponsored by Organogenesis.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 96 participants
- Enrollment target
Study 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.
Primary Outcome
The superiority of Gintuit relative to a pre-defined standard (50% success) for a 2 mm KT threshold after six months.
Interventions
- DEVICE Gintuit
- OTHER Autologous palatal tissue
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 96 participants |
| Start Date | 2007-10 |
| Est. Completion | 2008-12 |
| Phase | Phase 3 |
What the finished NCT00587834 record still lists
NCT00587834 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 96 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 2 interventions - of which Gintuit is the first listed.
NCT00587834 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00587834 about?
NCT00587834 is a clinical study titled "Safety and Efficacy of Gintuit(TM)for Oral Soft Tissue Regeneration". 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.
What is the current status of trial NCT00587834?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 96 participants. The study started on 2007-10. Estimated completion is 2008-12.
What interventions are being tested in trial NCT00587834?
The interventions under investigation include: Gintuit (DEVICE), Autologous palatal tissue (OTHER).
Who is sponsoring clinical trial NCT00587834?
This trial is sponsored by Organogenesis, which has 20 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00587834's enrollment target sits among peer trials
96 1718th of 2000 higher than 282 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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