Comparison of Straumann BoneCeramic vs. Allograft Bone in Extraction Sockets



Status:Terminated
Conditions:Dental
Therapuetic Areas:Dental / Maxillofacial Surgery
Healthy:No
Age Range:18 - 80
Updated:4/21/2016
Start Date:June 2006
End Date:October 2009

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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

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).

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.

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)
We found this trial at
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Yardley, Pennsylvania 19067
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Yardley, PA
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