Clinical Trials Directory

Trials / Terminated

TerminatedNCT00782236

Comparison of Straumann BoneCeramic vs. Allograft Bone in Extraction Sockets

Comparison of an Alloplast (Straumann Bone Ceramic) to an Allograft of Freeze Dried Bone (FDBA) for Preservation of the Alveolar Ridge Following Tooth Extraction: a Prospective, Randomized, Controlled Clinical Study

Status
Terminated
Phase
Phase 4
Study type
Interventional
Enrollment
13 (actual)
Sponsor
Institut Straumann AG · Industry
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

Summary

The primary objective of this study is to evaluate the implant stability at the time of abutment placement on implants placed in healed extraction sockets treated with Straumann BoneCeramic (SBC) versus Freeze Dried Bone Allograft (FDBA).

Detailed description

Subjects will undergo a single tooth extraction and then will be randomized to receive SBC or FDBA. Following a healing period of 6 months, a core biopsy will be taken of the augmented site and a dental implant will be placed. The subject will be followed for one year following dental implant placement for implant success and survival.

Conditions

Interventions

TypeNameDescription
DEVICEBone Graft MaterialAfter screening and enrollment, subjects will undergo tooth extraction of a single tooth with placement of Straumann Bone Ceramic or Freeze Dried Allograft Bone (FDBA) with a resorbable collagen membrane (Bio-Gide) for preservation of the alveolar ridge following tooth extraction. Following 6 months of healing, a core of bone will be taken from the surgical site and a dental implant will be placed. The subjects will then be followed for 12 months following dental implant placement.

Timeline

Start date
2006-06-01
Primary completion
2007-11-01
Completion
2009-10-01
First posted
2008-10-31
Last updated
2016-03-04

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00782236. Inclusion in this directory is not an endorsement.