At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 96 enrolled
Drug / intervention
Gintuit +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Clinical Trial to Evaluate Gintuit (TM) (Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen) as an Alternative to Tissue From the Palate to Enhance Oral Soft Tissue Regeneration and Wound Healing
In Brief
A Phase 3 clinical trial evaluating Gintuit and Autologous palatal tissue for Gingival Recession. Completed, enrolled 96 participants across 4 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGingival Recession
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartOct 2007
First PostedJan 2008
Primary CompletionDec 2008
TodayJul 2026
First PostedJan 7, 2008
Enrollment StartOct 1, 2007
Primary CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 18.5 years ago
Interventions
Gintuitdevice
Application of Gintuit at Day 0 to the gingival bed
Autologous palatal tissueother
Tissue will be harvested from the subject's palate and placed on the gingival bed