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

Missing Teeth Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01541345
• Other study ID #: 2012DR2009
• Status: Completed
• Phase: Phase 3
• Start date: February 2011
• Est. completion date: June 4, 2019

Study information

• Verified date: November 2021
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 4, 2019
• Est. primary completion date: April 25, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anodontia
• Missing Teeth
• Tooth Loss

Intervention

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)

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)

Locations

Country	Name	City	State
Austria	Department of Oral Surgery & Radiology, Dental School, Medical University of Graz	Graz
Switzerland	Center of Dental Medicine Clinic of Reconstructive Dentistry	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Countries where clinical trial is conducted

Austria,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	8 days and 4 month after augmentation surgery
Secondary	Bone quantity	Bone quantity measured at screening, augmentation surgery, suture removal, and during follow-up	at screening, augmentation surgery, suture removal, and during follow-up
Secondary	Patient's perception/acceptance	Patient's perception/acceptance (visual analogue scale VAS) measured at suture removal (8 days after augmentation surgery)	8 days after augmentation surgery