Lateral Ridge Augmentation Using Autogenous Bone Blocks or Xenogenic Bone Block Grafts Loaded With Recombinant Human Bone Morphogenic Protein 2

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01541345
First received: February 23, 2012
Last updated: February 18, 2014
Last verified: February 2014
  Purpose

Since there are no clinical studies available comparing the gold standard (autogenous bone graft plus resorbable membrane) to the promising combination of xenogenic bone graft loaded with rhBMP-2 in combination with a collagen membrane for localized ridge augmentation, the present exploratory study has been designed.

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.


Condition Intervention Phase
Missing Teeth
Device: Autogenous bone graft
Drug: InductOs
Procedure: Augmentation surgery
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Phase III, Randomized, Controlled Clinical Trial of Lateral Ridge Augmentation Using Autogenous Bone Blocks or Xenogenic Bone Block Grafts Loaded With Recombinant Human Bone Morphogenic Protein 2

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Bone quality/quantity [ Time Frame: 4 month after augmentation surgery ] [ Designated as safety issue: No ]
    Bone quantity at 4 months after augmentation surgery, measured manually by ridge measurements and volumetrically on the basis of optical impressions and radiological assessment (X-ray and cone beam CT). Bone quality at 4 months after augmentation surgery, measured by histological assessment (yields different proportion per patient).


Secondary Outcome Measures:
  • Complications [ Time Frame: 8 days and 4 month after augmentation surgery ] [ Designated as safety issue: Yes ]
    Complications (soft tissue, sensitivity) measured at suture removal (8 days after augmentation surgery) and 4 months after augmentation surgery. Any adverse events will be recorded for the treatment period from visit 1 to 4.

  • Bone quantity [ Time Frame: at screening, augmentation surgery, suture removal, and during follow-up ] [ Designated as safety issue: No ]
    Bone quantity measured at screening, augmentation surgery, suture removal, and during follow-up

  • Patient's perception/acceptance [ Time Frame: 8 days after augmentation surgery ] [ Designated as safety issue: No ]
    Patient's perception/acceptance (visual analogue scale VAS) measured at suture removal (8 days after augmentation surgery)


Estimated Enrollment: 24
Study Start Date: February 2011
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Device: 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)
Experimental: 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).
Drug: 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.
Procedure: 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

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • requiring implant therapy for the reconstruction of 1 to 4 missing teeth
  • 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:

  • Medication with a contraindication for implant therapy
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01541345

Locations
Switzerland
Center of Dental Medicine Clinic of Fixed and Removable Prosthodontics and Dental Material Science
Zurich, Switzerland, 8032
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Daniel S Thoma, Dr. Center of Dental Medicine Clinic of Fixed and Removable Prosthodontics and Dental Material Science, University of Zurich
  More Information

No publications provided

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01541345     History of Changes
Other Study ID Numbers: 2012DR2009
Study First Received: February 23, 2012
Last Updated: February 18, 2014
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Tooth Loss
Anodontia
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases
Tooth Abnormalities
Stomatognathic System Abnormalities
Congenital Abnormalities

ClinicalTrials.gov processed this record on July 23, 2014