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NCT01547962 · ClinicalTrials.gov registry record · NA
A Pilot Clinical Trial of Gintuit (TM)in Establishing a Functional Zone of Attached Gingiva
A NA study, sponsored by Organogenesis.
- Completed
- Registry status
- NA
- Development phase
- 25
- Enrollment target
NCT01547962: Completed NA study, sponsored by Organogenesis.
NCT01547962 is a NA study that has completed, run by Organogenesis. The registered enrollment target is 25 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01547962, a NA study, has completed, sponsored by Organogenesis.
- COMPLETED
- Registry status
- NA
- Development phase
- 25 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety and efficacy of Gintuit compared to a free autogenous graft using donor tissue harvested from the subject's palate in the treatment of subjects who have an insufficient zone of attached gingiva associated with at least two non adjacent teeth. The trial is designed to demonstrate non-inferiority between treatment and control in the change in amount of attached gingiva over the 6 month observation period. Gintuit will be placed as a graft in one of the deficient zones, and a free autogenous graft will be placed in the other. The grafts will be evaluated clinically to determine the change in the amount of attached gingiva and on at least three subjects, a small biopsy will be taken to allow histologic evaluation and comparison of both grafts.
Primary Outcome
Change in the amount of attached gingiva
Interventions
- DEVICE Gintuit
- OTHER autologous Free Gingival Graft (FGG)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2005-09 |
| Est. Completion | 2006-05 |
| Phase | NA |
What the finished NCT01547962 record still lists
NCT01547962 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Gintuit is the first listed.
NCT01547962 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01547962 about?
NCT01547962 is a clinical study titled "A Pilot Clinical Trial of Gintuit (TM)in Establishing a Functional Zone of Attached Gingiva". The purpose of this study is to evaluate the safety and efficacy of Gintuit compared to a free autogenous graft using donor tissue harvested from the subject's palate in the treatment of subjects who have an insufficient zone of attached gingiva associated with at least two non adjacent teeth. The t...
What is the current status of trial NCT01547962?
This trial is currently completed. It is a NA study. The enrollment target is 25 participants. The study started on 2005-09. Estimated completion is 2006-05.
What interventions are being tested in trial NCT01547962?
The interventions under investigation include: Gintuit (DEVICE), autologous Free Gingival Graft (FGG) (OTHER).
Who is sponsoring clinical trial NCT01547962?
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 NCT01547962's enrollment target sits among peer trials
25 1712th of 2000 higher than 265 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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