Clinical trial NCT00782236: 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
Overall status: TERMINATED
Phase: PHASE4
Conditions: Tooth Loss
Lead sponsor: Institut Straumann AG
Sponsor class: INDUSTRY
First posted: 2008-10-31
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: 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.
timeFrame: Six weeks following dental implant placement
Secondary outcomes:
measure: Histological evaluation
timeFrame: 6 months following tooth extraction
measure: Alveolar ridge width and height changes
timeFrame: 6 months following tooth extraction
measure: Periodontal measurements
timeFrame: 6 months following tooth extraction and 6 and 12 months following implant placement
measure: Grafting procedure success rate
timeFrame: 14 days, 1 month, 3 months, and 6 months following tooth extraction
measure: Implant success and survival rate
timeFrame: 6 weeks, 12 weeks, 6 months, and 12 months following implant placement
measure: Mesial and distal implant bone level changes
timeFrame: 6 weeks, 12 weeks, 6 months, and 12 months following implant placement
measure: Patient satisfaction
timeFrame: 6 and 12 months following implant placement
Other outcomes:
Locations:
city: Yardley
country: United States
facility: Private Practice
state: Pennsylvania
Study officials:
affiliation: Private Practice
name: Paul S. Rosen, DMD, MS
role: PRINCIPAL_INVESTIGATOR
References: