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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 is a Phase 3 study that has completed, run by Organogenesis. The registered enrollment target is 96 participants.

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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.

Interventions

  • DEVICE Gintuit
  • OTHER Autologous palatal tissue

Trial Details

FieldValue
Enrollment Target 96 participants
Start Date 2007-10
Est. Completion 2008-12
Phase Phase 3

Sponsor

Organogenesis

20 total trials

What the Registry Record Tells You About NCT00587834

The ClinicalTrials.gov registry entry for NCT00587834 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 96 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.

NCT00587834 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.