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

Institut Straumann AG1 site in 1 country13 target enrollmentJune 2006

ConditionsTooth Loss

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Tooth Loss
Sponsor: Institut Straumann AG
Enrollment: 13
Locations: 1
Primary Endpoint: Implant stability will be assessed by recording the maximum torque achieved when placing the abutment. The implant will be considered stable if a minimum of 35 Ncm of torque is achieved.
Status: Terminated
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

June 2006

End Date

October 2009

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Institut Straumann AG

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects must have voluntarily signed the informed consent form
•Subjects must be between the ages of 18 and 80
•Subjects must need a single tooth extraction in ADA sites 3-6 and 11-14 without septal bone in the maxilla and in ADA sites 19-30 without septal bone in the mandible and would benefit from prosthetic reconstruction with a dental implant
•Subjects must be committed to the study and the required follow-up visits
•Subjects must be in good general health as assessed by the Investigator

Exclusion Criteria

•Presence of conditions requiring chronic routine prophylactic use of antibiotics
•Pregnancy
•Medical conditions requiring prolonged use of steroids
•History of leukocyte dysfunction and deficiencies
•History of bleeding disorders
•History of neoplastic disease requiring the use of chemotherapy
•History of radiation therapy to the head and neck
•Subjects with a history of renal failure
•Subjects with severe or uncontrolled metabolic bone disorders
•Uncontrolled endocrine disorders

Outcomes

Primary Outcomes

Implant stability will be assessed by recording the maximum torque achieved when placing the abutment. The implant will be considered stable if a minimum of 35 Ncm of torque is achieved.

Time Frame: Six weeks following dental implant placement

Secondary Outcomes

Mesial and distal implant bone level changes(6 weeks, 12 weeks, 6 months, and 12 months following implant placement)
Periodontal measurements(6 months following tooth extraction and 6 and 12 months following implant placement)
Histological evaluation(6 months following tooth extraction)
Alveolar ridge width and height changes(6 months following tooth extraction)
Grafting procedure success rate(14 days, 1 month, 3 months, and 6 months following tooth extraction)
Implant success and survival rate(6 weeks, 12 weeks, 6 months, and 12 months following implant placement)
Patient satisfaction(6 and 12 months following implant placement)