Ridge augmentation with autogenous bone versus the combination of xenogenic graft material and a grooth factor (BMP2)
Phase 1
- Conditions
- Difference of percepetion/acceptance in patients trated with autogonous bone blocks or xenogenic bone block loaded with BMP2 to create a sufficent bonesituation Difference in quantity and quality of the augmented boneMedDRA version: 14.1 Level: PT Classification code 10064143 Term: Dental implantation System Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Dentistry [E06]
- Registration Number
- EUCTR2012-002002-46-AT
- Lead Sponsor
- niversitätsklinik für Zahn-, Mund- und Kieferheilkunde, Med Uni Graz, Department für zahnärztliche Chirurgie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 24
Inclusion Criteria
patients requiring implant therapy for the reconstruction of 1 to 4 missing teeth
patients revealing insufficient bone volume for implant placement
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 8
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4
Exclusion Criteria
severe diseases
medications with a contraindication for implant therapy
insufficent bone volume for harvesting a autogenous block
pregnancy and breast feeding
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Primary end point(s): perception of the patient<br> bone quantity (clinical and radiological evaluation)<br> bone quality (histological evaluation)<br> ;<br> Timepoint(s) of evaluation of this end point: 8 days after ridge augementation<br> 4 months after ridge augmentation (=timepoint of implant placement, biopsie)<br> 16,40 and 64 months after ridge augmentation (clinical and radiological evaluation of the current ridge situation)<br> ;<br> Main Objective: Patient's perception <br> bone quantity<br> bone quality<br> <br> ;Secondary Objective: safety and tolerabiltiy (adverse effect, soft tissue, sensitivity) of xenogenic grafting block loaded with BMP2 in comparison with autogenous bone block
- Secondary Outcome Measures
Name Time Method <br> Secondary end point(s): complications (soft tissue, sensitivity)<br> adverse effects<br> ;<br> Timepoint(s) of evaluation of this end point: 8 days after ridge augmentation<br> 4 months after ridge augmentatin (=implant placement)<br> 16,40 and 64 months after ridge augmentation<br>