Ridge augmentation with autogenous bone versus the combination of xenogenic graft material and a grooth factor (BMP2)

A phase III, randomized, controlled clinical pilot trial of lateral ridge augmentation using autogenous bone blocks or xenogenic bone block grafts loaded with recombinant human bone morphogenic protein 2 - BMP2

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-002002-46-AT

Enrollment

Registered

2013-04-04

Start date

2013-05-07

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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 bone MedDRA version: 14.1 Level: PT Classification code 10064143 Term: Dental implantation System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: InductOs Pharmaceutical Form: Dental gel INN or Proposed INN: DIBOTERMIN ALFA CAS Number: 246539-15-1 Concentration unit: mg

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: severe diseases medications with a contraindication for implant therapy insufficent bone volume for harvesting a autogenous block pregnancy and breast feeding

Design outcomes

Primary

Measure	Time frame
Primary end point(s): perception of the patient bone quantity (clinical and radiological evaluation) bone quality (histological evaluation) ; Timepoint(s) of evaluation of this end point: 8 days after ridge augementation 4 months after ridge augmentation (=timepoint of implant placement, biopsie) 16,40 and 64 months after ridge augmentation (clinical and radiological evaluation of the current ridge situation) ; Main Objective: Patient's perception bone quantity bone quality ;Secondary Objective: safety and tolerabiltiy (adverse effect, soft tissue, sensitivity) of xenogenic grafting block loaded with BMP2 in comparison with autogenous bone block	—

Measure

Time frame

Primary end point(s): perception of the patient bone quantity (clinical and radiological evaluation) bone quality (histological evaluation) ; Timepoint(s) of evaluation of this end point: 8 days after ridge augementation 4 months after ridge augmentation (=timepoint of implant placement, biopsie) 16,40 and 64 months after ridge augmentation (clinical and radiological evaluation of the current ridge situation) ; Main Objective: Patient's perception bone quantity bone quality ;Secondary Objective: safety and tolerabiltiy (adverse effect, soft tissue, sensitivity) of xenogenic grafting block loaded with BMP2 in comparison with autogenous bone block

—

Secondary

Measure	Time frame
Secondary end point(s): complications (soft tissue, sensitivity) adverse effects ; Timepoint(s) of evaluation of this end point: 8 days after ridge augmentation 4 months after ridge augmentatin (=implant placement) 16,40 and 64 months after ridge augmentation	—

Countries

Austria, Switzerland

Contacts

Public ContactDepartment für zahnärztl. Chirurgie

Universitätsklinik für Zahn-, Mund- und Kieferheilkunde, Med Uni Graz

mi.payer@medunigraz.at004331638513280

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026