Comparison of Straumann BoneCeramic vs. Allograft Bone in Extraction Sockets

NCT00782236 | Terminated Phase 4

• 1 other identifier: CR 02/06
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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).

Conditions

Tooth Loss

Outcome Measures

Primary Outcomes (1)

• 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.

  Six weeks following dental implant placement

Secondary Outcomes (7)

• Histological evaluation

  6 months following tooth extraction

• Alveolar ridge width and height changes

  6 months following tooth extraction

• Periodontal measurements

  6 months following tooth extraction and 6 and 12 months following implant placement

• 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

Study Arms (2)

Straumann BoneCeramic

ACTIVE COMPARATOR

In the test group, the subjects will receive the Bone Graft Material Straumann BoneCeramic in combination with a collagen membrane for preservation of the alveolar ridge after tooth extraction.

Device: Bone Graft Material

Freeze Dried Allograft Bone

ACTIVE COMPARATOR

In the control group, the subjects will receive Bone Graft Material Freeze Dried Allograft Bone in combination with a collagen membrane for preservation of the alveolar ridge after tooth extraction.

Device: Bone Graft Material

Interventions

Bone Graft Material DEVICE

After 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.

Also known as: Synthetic bone substitute, Allograft bone

Freeze Dried Allograft Bone; Straumann BoneCeramic

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Subjects who knowingly have HIV or hepatitis
• Physical handicaps that would interfere with the ability to perform adequate oral hygiene
• Subjects who have undergone administration of any investigational drug or device within 30 days of enrollment in the study
• Alcoholism or drug abuse
• Subjects who are heavy smokers (\>10 cigarettes per day or cigar equivalents) or chew tobacco

Sponsors & Collaborators

• Institut Straumann AG: lead

Study Sites (1)

Private Practice

Yardley, Pennsylvania, 19067, United States

Location

MeSH Terms

Conditions

Tooth Loss

Interventions

Bone Transplantation

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Intervention Hierarchy (Ancestors)

Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Orthopedic Procedures; Surgical Procedures, Operative; Transplantation

Study Officials

• Paul S. Rosen, DMD, MS

  Private Practice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2008
• First Posted: October 31, 2008
• Study Start: June 1, 2006
• Primary Completion: November 1, 2007
• Study Completion: October 1, 2009
• Last Updated: March 4, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)