Back to resultsComparison of Straumann BoneCeramic vs. Allograft Bone in Extraction Sockets
Primary Purpose
Tooth Loss
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Bone Graft Material
Sponsored by
About this trial
This is an interventional treatment trial for Tooth Loss
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
- 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)
Sites / Locations
- Private Practice
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Straumann BoneCeramic
Freeze Dried Allograft Bone
Arm Description
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.
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.
Outcomes
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.
Secondary Outcome Measures
Histological evaluation
Alveolar ridge width and height changes
Periodontal measurements
Grafting procedure success rate
Implant success and survival rate
Mesial and distal implant bone level changes
Patient satisfaction
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00782236
Brief Title
Comparison of Straumann BoneCeramic vs. Allograft Bone in Extraction Sockets
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Terminated
Why Stopped
Lack of enrollment
Study Start Date
June 2006 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Straumann AG
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Straumann BoneCeramic
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Freeze Dried Allograft Bone
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Bone Graft Material
Other Intervention Name(s)
Synthetic bone substitute, Allograft bone
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Histological evaluation
Time Frame
6 months following tooth extraction
Title
Alveolar ridge width and height changes
Time Frame
6 months following tooth extraction
Title
Periodontal measurements
Time Frame
6 months following tooth extraction and 6 and 12 months following implant placement
Title
Grafting procedure success rate
Time Frame
14 days, 1 month, 3 months, and 6 months following tooth extraction
Title
Implant success and survival rate
Time Frame
6 weeks, 12 weeks, 6 months, and 12 months following implant placement
Title
Mesial and distal implant bone level changes
Time Frame
6 weeks, 12 weeks, 6 months, and 12 months following implant placement
Title
Patient satisfaction
Time Frame
6 and 12 months following implant placement
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul S. Rosen, DMD, MS
Organizational Affiliation
Private Practice
Official's Role
Principal Investigator
Facility Information:
Facility Name
Private Practice
City
Yardley
State/Province
Pennsylvania
ZIP/Postal Code
19067
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Comparison of Straumann BoneCeramic vs. Allograft Bone in Extraction Sockets
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