Comparison of Straumann BoneCeramic vs. Allograft Bone in Extraction Sockets

This study has been terminated.
(Lack of enrollment)
Sponsor:
Information provided by (Responsible Party):
Institut Straumann AG
ClinicalTrials.gov Identifier:
NCT00782236
First received: October 28, 2008
Last updated: June 6, 2012
Last verified: June 2012
  Purpose

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).


Condition Intervention Phase
Tooth Loss
Device: Bone Graft Material
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Institut Straumann AG:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Histological evaluation [ Time Frame: 6 months following tooth extraction ] [ Designated as safety issue: No ]
  • Alveolar ridge width and height changes [ Time Frame: 6 months following tooth extraction ] [ Designated as safety issue: No ]
  • Periodontal measurements [ Time Frame: 6 months following tooth extraction and 6 and 12 months following implant placement ] [ Designated as safety issue: No ]
  • Grafting procedure success rate [ Time Frame: 14 days, 1 month, 3 months, and 6 months following tooth extraction ] [ Designated as safety issue: No ]
  • Implant success and survival rate [ Time Frame: 6 weeks, 12 weeks, 6 months, and 12 months following implant placement ] [ Designated as safety issue: No ]
  • Mesial and distal implant bone level changes [ Time Frame: 6 weeks, 12 weeks, 6 months, and 12 months following implant placement ] [ Designated as safety issue: No ]
  • Patient satisfaction [ Time Frame: 6 and 12 months following implant placement ] [ Designated as safety issue: No ]

Enrollment: 13
Study Start Date: June 2006
Study Completion Date: October 2009
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Straumann BoneCeramic Device: Bone Graft Material
Straumann BoneCeramic versus Freeze Dried Allograft Bone
Other Names:
  • Synthetic bone substitute
  • Allograft bone
Active Comparator: Freeze Dried Allograft Bone Device: Bone Graft Material
Straumann BoneCeramic versus Freeze Dried Allograft Bone
Other Names:
  • Synthetic bone substitute
  • Allograft bone

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • 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
  • Conditions or circumstances, in the opinion of the Investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance or unreliability
  • Local inflammation including untreated periodontitis
  • Mucosal diseases such as erosive lichen planus
  • History of local radiation therapy
  • Presence of oral lesions (such as ulcerations or malignancy)
  • Bone defects that exclude implant restoration
  • Subjects who have a full mouth plaque level >30% at the baseline visit
  • Severe bruxing or clenching habits
  • Persistent intra-oral infection
  • Subjects presenting with an acute abscess in the tooth to be extracted or in the adjacent teeth to the extraction site (sites with presence of asymptomatic chronic lesions are eligible)
  • Subjects with inadequate oral hygiene or unmotivated for adequate home care
  • At the time of tooth extraction, if any bony wall is severely damaged or completely lost (i.e., anything other than a four wall extraction socket)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00782236

Locations
United States, Pennsylvania
Private Practice
Yardley, Pennsylvania, United States, 19067
Sponsors and Collaborators
Institut Straumann AG
Investigators
Principal Investigator: Paul S. Rosen, DMD, MS Private Practice
  More Information

No publications provided

Responsible Party: Institut Straumann AG
ClinicalTrials.gov Identifier: NCT00782236     History of Changes
Other Study ID Numbers: CR 02/06
Study First Received: October 28, 2008
Last Updated: June 6, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Tooth Loss
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases

ClinicalTrials.gov processed this record on September 14, 2014