NCT01929954

Safety Study of Gintuit™ in Subjects Requiring Socket Grafting

Phase 1/2, Randomized, Controlled Assessment of the Safety Of Gintuit™ Versus Bio-Gide® in Subjects Requiring Socket Grafting

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Organogenesis · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, randomized, controlled, parallel group Phase 1/2 assessment of the safety of GINTUIT versus Bio-Gide in subjects who have a posterior tooth requiring extraction. The incidence and severity of adverse events will be summarized by group (GINTUIT and Bio-Gide).

Detailed description

This study will evaluate the safety of GINTUIT as compared with Bio-Gide in subjects who have a posterior tooth requiring extraction. The use of GINTUIT in this investigational clinical indication may eliminate/reduce the need for aggressive flap advancement with its concomitant morbidity, while, at the same time, obtaining stable closure over a grafted socket. It is anticipated that GINTUIT will facilitate tissue granulation, followed by tissue coverage with site appropriate tissue (ie, keratinized tissue) that is needed for long term stability of the final restoration.

Conditions

• Edentulous Alveolar Ridge

Interventions

Type	Name	Description
BIOLOGICAL	Gintuit	One time placement of Gintuit over socket graft.
DEVICE	Bio-Gide	One time placement of Bio-Gide over socket graft.

Timeline

• Start date: 2013-07-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2013-08-28
• Last updated: 2015-09-24

Locations

1 site across 1 country: United States