Safety Study of Gintuit™ in Subjects Requiring Socket Grafting

Edentulous Alveolar Ridge Clinical Trial

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

Status Terminated

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Edentulous Alveolar Ridge

• NCT number: NCT01929954
• Study type: Interventional
• Source: Organogenesis
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: July 2013
• Completion date: March 2015