Guided Bone Regeneration Around Immediate Implants

Missing Tooth Clinical Trial

Official title: The Effectiveness of the Cytoplast Technique in Preventing Bone Loss Around Immediate Implant Placement in the Esthetic Zone. A Randomized Clinical Trial.

Status Completed

Clinical Trial Summary

An important result of healing after tooth extraction is a reduction in dimensions of the remaining bone at that site. This reduction of bone volume precludes successful restoration of the space using a dental implant. Bone augmentation has shown promise in clinical reports to reduce this loss of bone volume, thus allowing implant placement and restoration. The purpose of this study is to evaluate the clinical and radiographic outcomes of guided bone regeneration around dental implants placed in fresh extraction sockets.

Clinical Trial Description

Aim: The purpose of this clinical study is to investigate the effect of a non-resorbable polytetrafluoroethylene (PTFE) membrane on immediate implant placement in the esthetic zone.

Material and Methods: Systemically healthy subjects presenting with a hopeless tooth in the maxillary premolar or anterior region will be recruited in the study. Following a minimally traumatic tooth extraction, subjects will be randomly distributed into one of two treatment groups, a Membrane (Test) or a No Membrane (Control) group. Both groups will receive immediate placement of an implant along with placement of a bone graft material to fill the spaces around the implant. Sites in the test group will receive a non-resorbable PTFE membrane over the socket, whereas those in the control group will receive a collagen dressing over the socket. At sites in the test group, the membrane will be removed at 4 weeks. A second stage surgery and placement of a provisional restoration will be carried out 4 months after implant placement. Final restorations will be placed 3 months after placement of the provisional restoration. Clinical and radiographic measurements will be performed at baseline, implant placement, placement of provisional and final restorations and at the 5-month recall visit. ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anodontia
• Missing Tooth
• Tooth Loss

• NCT number: NCT01628367
• Study type: Interventional
• Source: University of Michigan
• Status: Completed
• Phase: Phase 4
• Start date: July 2012
• Completion date: May 2014