Comparison of Synthetic Bone Substitute and a Bovine-derived Xenograft in Horizontal Bone Augmentation

Study Overview
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Brief Summary
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The objective of the study is to test the efficacy on bone formation of Straumann Bone Ceramic as a grafting material applied in buccal bone dehiscences on simultaneously placed oral implants.

Detailed Description
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This is a randomized, controlled, split mouth, prospective, single centre study. The total study duration for each patient should be 76 weeks +/-18 months. In total 8 visits per patient are scheduled in this study. The study devices Straumann Bone Ceramic and Bio-Oss are CE-marked, and approved by the FDA. The products are used within the indication. One center in Beligum will participate.

Official Title
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A Randomised Controlled Spilt-mouth Clinical Study Comparing a Synthetic Bone Substitute and a Bovine-derived Xenograft in Primarily Horizontal Bone Augmentation Procedure During Placement of Straumann Oral Implants

Conditions
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Jaw, Edentulous, Jaw, Edentulous, Partially

Intervention / Treatment
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* Device: Straumann BoneCeramic
* Device: Bio-Oss


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females, 18 years to 80 years of age At least two missing teeth up to full edentulous arches. Desiring implant supported restorations. Both study implants should have a self-containing (2-wall) buccal dehiscence defect after oral implant placement (at least 3.0 mm / max. 5.0 mm defect in apico-coronal aspect to be measured from the boarder of the rough surface of the oral implant to the bottom of the defect). At least 4mm of the implant, measured from the apical end to the lowest margin of the bone level, should be covered with bone. Sufficient bone volume such that both oral implants will not encroach on vital structures and primary stability of the oral implant can be achieved; Patients must be committed to the study and must sign informed consent. Patient in good general health as documented by self assessment; Full mouth plaque score of <20%; Exclusion Criteria: Any systemic medical condition that could interfere with the surgical procedure or planned treatment; Current pregnancy or breast feeding/ lactating at the time of recruitment; Physical handicaps that would interfere with the ability to perform adequate oral hygiene; Alcoholism or chronically drug abuse causing systemic compromise. Patients who smoke more than 20 cigarettes per day. Conditions or circumstances, in the opinion of the investigator, which could represent a general contra-indication for surgical procedure or would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, or unreliability Lack of primary stability of 1 or both implant(s) at surgery, measured by hand testing. In this instance the patient must be withdrawn and treated accordingly. Mucosal diseases such as erosive lichen planus History of local radiation therapy. Presence of osseous pathologies. Presence of oral lesions (such as ulceration, malignancy) Severe bruxing or clenching habits. Local inflammation, including untreated periodontitis. Bone surgery at the implant site(s) (bone grafts, guided tissue regeneration techniques for bone enhancement) prior to implant placement unless performed more than 6 months prior to implant placement. Patients presenting clinical and radiological signs and symptoms of maxillary sinus disease. Existing teeth in the residual dentition with untreated endodontic pathologies. Patients with inadequate oral hygiene or unmotivated for adequate home care

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

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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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>Straumann BoneCeramic | Device: Straumann BoneCeramic<br>* Bone augmentation procedure performed with Bone Ceramic<br>|
| Active Comparator: Bio-Oss<br>Geistlich Bio-Oss | Device: Bio-Oss<br>* Bone Augmentation procedure performed with Bio Oss<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Vertical Height of Buccal Defects | Change of vertical height of buccal defects over 26 weeks, measured during 1st - and 2nd- stage surgery | Baseline to 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant Success Rate | The success of oral implant will be determined according to the following parameters: Absence of any continuous peri-implant radiolucency based on radiographic findings. Absence of implant mobility (based on hand testing) Absence of a peri-implant infection with suppuration. Absence of a recurrent peri-implant infection with suppuration (where an infection is termed recurrent if it is observed at two or more follow-up visits after treatment with systemic antibiotics). Bone level changes evaluated on periapical radiographs around implants less than 1 mm during the first year of loading, starting at abutment connection. | 6 months | 
| Implant Survival Rate | A surviving implant will be considered an implant fulfilling the following criteria: Absence of any continuous peri-implant radiolucency based on radiographic findings. Absence of implant mobility. Absence of a recurrent peri-implant infection with suppuration (where an infection is termed recurrent if it is observed at two or more follow-up visits after treatment with systemic antibiotics). Absence of pain or any other adverse observation by the patient, so that the implant has to be removed. | 6 Months | 
| Implant Success Rate | The success of oral implant will be determined according to the following parameters: Absence of any continuous peri-implant radiolucency based on radiographic findings. Absence of implant mobility (based on hand testing) Absence of a peri-implant infection with suppuration. Absence of a recurrent peri-implant infection with suppuration (where an infection is termed recurrent if it is observed at two or more follow-up visits after treatment with systemic antibiotics). Bone level changes evaluated on periapical radiographs around implants less than 1 mm during the first year of loading, starting at abutment connection. | 12 months | 
| Implant Survival Rate | A surviving implant will be considered an implant fulfilling the following criteria: Absence of any continuous peri-implant radiolucency based on radiographic findings. Absence of implant mobility. Absence of a recurrent peri-implant infection with suppuration (where an infection is termed recurrent if it is observed at two or more follow-up visits after treatment with systemic antibiotics). Absence of pain or any other adverse observation by the patient, so that the implant has to be removed. | 12 months |