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NCT00679081 · ClinicalTrials.gov registry record · Phase 1
A Pilot Study of CelTx(TM) (Apligraf®) in the Treatment of Gingival Recession Requiring Root Coverage
A Phase 1 study, sponsored by Organogenesis.
- Terminated
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT00679081: Clinical Trial Phase 1 study, sponsored by Organogenesis.
NCT00679081 is a Phase 1 study that was terminated before completion, run by Organogenesis. The registered enrollment target is 15 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00679081, a Phase 1 study, was terminated before completion, sponsored by Organogenesis.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study 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.
Primary Outcome
Adverse events were collected at every visit throughout the 6 month duration. An AE is defined as any adverse change in the subject's medical status when compared with the subject's baseline condition, whether or not the event is related to the study device or a study procedure; or an exacerbation (either in frequency or severity) in a subject's pre-existing condition.
Interventions
- DEVICE CelTx
- OTHER Autologous sub-epithelial connective tissue graft
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2008-05 |
| Est. Completion | 2010-09 |
| Phase | Phase 1 |
Why NCT00679081 stopped before completion
NCT00679081 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 2 interventions - of which CelTx is the first listed.
NCT00679081 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00679081 about?
NCT00679081 is a clinical study titled "A Pilot Study of CelTx(TM) (Apligraf®) in the Treatment of Gingival Recession Requiring Root Coverage". 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 demo...
What is the current status of trial NCT00679081?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2008-05. Estimated completion is 2010-09.
What interventions are being tested in trial NCT00679081?
The interventions under investigation include: CelTx (DEVICE), Autologous sub-epithelial connective tissue graft (OTHER).
Who is sponsoring clinical trial NCT00679081?
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 NCT00679081's enrollment target sits among peer trials
15 1798th of 2000 higher than 157 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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