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

NCT01541345 | Completed Phase 3

• 1 other identifier: 2012DR2009
• Study Type: interventional
• Target: 24
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Missing Teeth

Outcome Measures

Primary Outcomes (1)

• Bone quality/quantity

  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).

  4 month after augmentation surgery

Secondary Outcomes (3)

• Complications

  8 days and 4 month after augmentation surgery

• Bone quantity

  at screening, augmentation surgery, suture removal, and during follow-up

• Patient's perception/acceptance

  8 days after augmentation surgery

Study Arms (2)

Control Group (A)

ACTIVE COMPARATOR

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

Test group (B)

EXPERIMENTAL

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; Procedure: Augmentation surgery

Interventions

Autogenous bone graft DEVICE

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)

Control Group (A)

InductOs DRUG

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.

Test group (B)

Augmentation surgery PROCEDURE

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)

Test group (B)

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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,

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (2)

Department of Oral Surgery & Radiology, Dental School, Medical University of Graz

Graz, Austria

Location

Center of Dental Medicine Clinic of Reconstructive Dentistry

Zurich, 8032, Switzerland

Location

MeSH Terms

Conditions

Anodontia

Interventions

Bone Morphogenetic Protein 2

Condition Hierarchy (Ancestors)

Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Bone Morphogenetic Proteins; TGF-beta Superfamily Proteins; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Daniel S Thoma, Prof. Dr.

  Clinic of Reconstructive Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2012
• First Posted: February 29, 2012
• Study Start: February 1, 2011
• Primary Completion: April 25, 2014
• Study Completion: June 4, 2019
• Last Updated: December 2, 2021

Record last verified: 2021-11

Locations

AU (1); CH (1)