Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a NA study that has completed, run by Organogenesis. The registered enrollment target is 25 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01547962
The ClinicalTrials.gov registry entry for NCT01547962 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Organogenesis, which has 20 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Gintuit is the first listed.
NCT01547962 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.