Comparison of Straumann BoneCeramic vs. Allograft Bone in Extraction Sockets

Study Overview
=================
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.

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

Conditions
-----------------
Tooth Loss

Intervention / Treatment
-----------------
* Device: Bone Graft Material


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Straumann BoneCeramic<br>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<br>* 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.<br>* Other names: Allograft bone;|
| Active Comparator: Freeze Dried Allograft Bone<br>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<br>* 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.<br>* Other names: Allograft bone;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Mesial and distal implant bone level changes |  | 6 weeks, 12 weeks, 6 months, and 12 months following implant placement | 
| Patient satisfaction |  | 6 and 12 months following implant placement |