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

Primary Purpose

Missing Teeth

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Autogenous bone graft
InductOs
Augmentation surgery
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Missing Teeth

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Oral Surgery & Radiology, Dental School, Medical University of Graz
  • Center of Dental Medicine Clinic of Reconstructive Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Group (A)

Test group (B)

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Complications
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
Bone quantity measured at screening, augmentation surgery, suture removal, and during follow-up
Patient's perception/acceptance
Patient's perception/acceptance (visual analogue scale VAS) measured at suture removal (8 days after augmentation surgery)

Full Information

First Posted
February 23, 2012
Last Updated
November 21, 2021
Sponsor
University of Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT01541345
Brief Title
Lateral Ridge Augmentation Using Autogenous Bone Blocks or Xenogenic Bone Block Grafts Loaded With Recombinant Human Bone Morphogenic Protein 2
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
April 25, 2014 (Actual)
Study Completion Date
June 4, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Missing Teeth

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group (A)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Test group (B)
Arm Type
Experimental
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Autogenous bone graft
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
InductOs
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Augmentation surgery
Intervention Description
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)
Primary Outcome Measure Information:
Title
Bone quality/quantity
Description
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).
Time Frame
4 month after augmentation surgery
Secondary Outcome Measure Information:
Title
Complications
Description
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.
Time Frame
8 days and 4 month after augmentation surgery
Title
Bone quantity
Description
Bone quantity measured at screening, augmentation surgery, suture removal, and during follow-up
Time Frame
at screening, augmentation surgery, suture removal, and during follow-up
Title
Patient's perception/acceptance
Description
Patient's perception/acceptance (visual analogue scale VAS) measured at suture removal (8 days after augmentation surgery)
Time Frame
8 days after augmentation surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel S Thoma, Prof. Dr.
Organizational Affiliation
Clinic of Reconstructive Dentistry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Oral Surgery & Radiology, Dental School, Medical University of Graz
City
Graz
Country
Austria
Facility Name
Center of Dental Medicine Clinic of Reconstructive Dentistry
City
Zurich
ZIP/Postal Code
8032
Country
Switzerland

12. IPD Sharing Statement

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

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