Safety Study of Gintuit™ 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

Clinical Trial Details

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

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05769673` - Soft and Hard Tissue Changes Around Implants	N/A
Active, not recruiting	`NCT06034067` - Osseodensification Versus Conventional Drilling for Implant Site Preparation	N/A
Not yet recruiting	`NCT05513170` - Closed Sinus Tenting Using Densah Burs Osteotomy Versus Conventional Osteotomy in Localized Pneumatization	N/A
Recruiting	`NCT05366985` - Dimensional Changes of the Labial Alveolar Ridge After Socket Shield Technique With Computer Guided Root Sectioning	N/A
Not yet recruiting	`NCT04438616` - Comparison of Patient Satisfaction and Primary Implant Stability Between Two Different Magnetic Attachment	N/A
Completed	`NCT04543292` - Clinical Evaluation of Polytetrafluoroethylene (PTFE, MATFILL) for the Sealing of Prosthetic Chimneys.	N/A
Recruiting	`NCT05260892` - Incisors Single-Unit Rehabilitation With Narrow GM Implants
Completed	`NCT06157047` - Evaluation of the Crestal Bone Expansion Obtained With the Magnetic Mallet® During the Preparation of the Implant Site	N/A
Not yet recruiting	`NCT03674554` - Prosthetic Complications of Screw Retained Restoration	N/A
Recruiting	`NCT05717478` - Regeneration of Alveolar Sockets With rhBMP-2-loaded Bovine Bone Mineral	N/A
Recruiting	`NCT05081284` - Clinical Outcomes of Immediate Implants With or Without a Volume-stable Collagen Matrix	N/A
Completed	`NCT04111250` - Crestal vs Lateral Sinus Lift Augmentation	N/A
Recruiting	`NCT05141331` - Comparison of Piezoelectric Split-crest Technique Versus Expansion Using Hand Driven Ridge Expanders in Treatment of Maxillary Narrow Ridges	N/A
Not yet recruiting	`NCT04766255` - Behavioral Comparison of Three Different Graft Materials to Increase Soft Tissue Thickness Around Dental Implants.	Phase 4
Completed	`NCT03714139` - Immediate Loading a Histological Study	N/A
Completed	`NCT06182670` - The Role of a New Prosthodontics Device in Hard and Soft Tissue Changes After Subcrestal Implant Placement	N/A
Completed	`NCT05821673` - Soft Tissue Integration of Different Abutment Surfaces	N/A
Recruiting	`NCT04915677` - Edentulous Sites Augmented With Collagen Matrix or CTG	N/A
Not yet recruiting	`NCT06449443` - Zero Echo Time MR for the Assessment of Maxillary Sinus and Dental Regions
Recruiting	`NCT06012071` - Two-piece Zirconia Implants With Two Various Platforms	N/A