Lateral Ridge Augmentation Using Autogenous Bone Blocks or Xenogenic Bone Block Grafts Loaded With Recombinant Human Bone Morphogenic Protein 2
NCT ID: NCT01541345
Last Updated: 2021-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
24 participants
INTERVENTIONAL
2011-02-28
2019-06-04
Brief Summary
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The aim of the present study is therefore to test whether or not the application of a xenogenic bone block loaded with rhBMP-2 will results in clinically, radiographically and histologically similar outcomes as the gold standard (autogenous bone block) for the regeneration of chronic ridge defects.
The investigators expect that there is no difference in bone quantity and quality between the two methods and that the use of the test treatment will be more user and patient friendly according to the patient perception/acceptance since no second surgical site will be necessary as well as cause less complications.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Control Group (A)
Bone augmentation will be performed using autogenous bone from the retromolar or chin area followed by a fixation with titanium screws at the recipients site; filled with deproteinized bovine bone mineral (DBBM) particles (Bio-Oss®, Geistlich Pharma AG, Wolhusen, Switzerland) and covered with a collagen membrane (Bio-Gide®, Geistlich Pharma AG, Switzerland). These course of action is well documented in the literature and standard procedures.
Autogenous bone graft
Bone augmentation will be performed using autogenous bone from the retromolar or chin area followed by a fixation with titanium screws at the recipients site; filled with deproteinized bovine bone mineral (DBBM) particles (Bio-Oss®, Geistlich Pharma AG, Wolhusen, Switzerland) and covered with a collagen membrane (Bio-Gide®, Geistlich Pharma AG, Switzerland)
Test group (B)
The bone augmentation will be performed using a deproteinized bovine bone mineral (DBBM) block (Bio-Oss Spongiosa Block®, Geistlich Parma AG, Wolhusen, Switzerland) and a collagen membrane (Bio-Gide®, Geistlich Pharma AG, Switzerland) similarly to the control group. In addition, DBBM will be loaded with rhBMPH-2 (InductOs®, Pfizer AG, Zurich, Switzerland).
InductOs
CE-marked medical device Bio-Oss Spongiosa Block® (xenogenic bone) loaded with InductOs® (1.5 mg Dibotermin alfa / ml) covered with Bio-Gide® (collagen membrane). One time application at augmentation surgery.
Augmentation surgery
CE-marked medical device Bio-Oss Spongiosa Block® (xenogenic bone) loaded with InductOs® (1.5 mg Dibotermin alfa / ml) covered with Bio-Gide® (collagen membrane)
Interventions
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Autogenous bone graft
Bone augmentation will be performed using autogenous bone from the retromolar or chin area followed by a fixation with titanium screws at the recipients site; filled with deproteinized bovine bone mineral (DBBM) particles (Bio-Oss®, Geistlich Pharma AG, Wolhusen, Switzerland) and covered with a collagen membrane (Bio-Gide®, Geistlich Pharma AG, Switzerland)
InductOs
CE-marked medical device Bio-Oss Spongiosa Block® (xenogenic bone) loaded with InductOs® (1.5 mg Dibotermin alfa / ml) covered with Bio-Gide® (collagen membrane). One time application at augmentation surgery.
Augmentation surgery
CE-marked medical device Bio-Oss Spongiosa Block® (xenogenic bone) loaded with InductOs® (1.5 mg Dibotermin alfa / ml) covered with Bio-Gide® (collagen membrane)
Eligibility Criteria
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Inclusion Criteria
* revealing insufficient bone volume for implant placement (cases where less than 50% of the implant surface would be surrounded by native bone) requiring bone augmentation procedure
Exclusion Criteria
* Previous administration of InductOs
* Skeletal immaturity
* Any active malignancy or patient undergoing treatment for a malignancy
* An active infection at the operative site
* Persistent compartment syndrome or neurovascular residua of compartment syndrome
* Pathological fractures such as those observed in (but not limited to) Paget's disease or in metastatic bone
* Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product,
* Contraindications on ethical grounds,
* Pregnancy,
* Intention to become pregnant during the course of the study,
* Breast feeding,
* Treatment with other investigational products,
* Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc),
* Known or suspected non-compliance, drug or alcohol abuse,
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia or confusional state of the subject,
* Participation in another study with investigational drug within the 30 days preceding and during the present study,
* Previous enrolment into the current study,
* Enrolment of the investigator, his/her family members, employees and other dependent persons,
* Patients where autogenous bone cannot be harvested.
20 Years
75 Years
ALL
No
Sponsors
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University of Zurich
OTHER
Responsible Party
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Principal Investigators
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Daniel S Thoma, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Clinic of Reconstructive Dentistry
Locations
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Department of Oral Surgery & Radiology, Dental School, Medical University of Graz
Graz, , Austria
Center of Dental Medicine Clinic of Reconstructive Dentistry
Zurich, , Switzerland
Countries
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Other Identifiers
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2012DR2009
Identifier Type: -
Identifier Source: org_study_id