Clinical Trials Register

Summary
EudraCT Number:	2012-002002-46
Sponsor's Protocol Code Number:	2012-BMP1-2
National Competent Authority:	Austria - BASG
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2013-04-04
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Austria - BASG

A.2

EudraCT number

2012-002002-46

A.3

Full title of the trial

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

Eine randomisierte kontrollierte Phase III Pilotstudie zur lateralen Kieferkammaugmentation mittels autologer oder xenogener mit rekombinantem BMP beladenen Knochenblöcken.

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

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

Kieferaufbau mit Eigenknochen im Vergleich mit einer Kombination aus Ersatzmaterial und einem Wachstumsfaktor (BMP2)

A.3.2

Name or abbreviated title of the trial where available

BMP2

A.4.1

Sponsor's protocol code number

2012-BMP1-2

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Universitätsklinik für Zahn-, Mund- und Kieferheilkunde, Med Uni Graz, Department für zahnärztliche Chirurgie
B.1.3.4	Country	Austria
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Geistlich Pharma
B.4.2	Country	Switzerland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Universitätsklinik für Zahn-, Mund- und Kieferheilkunde, Med Uni Graz
B.5.2	Functional name of contact point	Department für zahnärztl. Chirurgie
B.5.3	Address:
B.5.3.1	Street Address	Auenbruggerplatz 12
B.5.3.2	Town/ city	Graz
B.5.3.3	Post code	8036
B.5.3.4	Country	Austria
B.5.4	Telephone number	004331638513280
B.5.5	Fax number	004331638516858
B.5.6	E-mail	mi.payer@medunigraz.at

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	InductOs
D.2.1.1.2	Name of the Marketing Authorisation holder	Medtronic BioPharma B.V.
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Dental gel
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Dental use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	DIBOTERMIN ALFA
D.3.9.1	CAS number	246539-15-1
D.3.9.4	EV Substance Code	SUB16416MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1.5 to 1.5
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

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

Unterschiede in Wahrnehmung und Akzeptanz der Patienten hinsichtlich autogenem Blocktransplantat oder xenogenem Ersatzmaterial im Kombination mit BMP2 zur Schaffung eines ausreichenden Implantatlagers
Unterschiede hinsichtllich Quantität und Qualität des augmentiereten Knochens

E.1.1.1

Medical condition in easily understood language

Difference between autogenous bone und xenogenic graft material in combination with a grooth factor (BMP2) regarding perception and quantity and quality of the bone

Unterschiede zwischen Eigenknochentransplantat und der Kombination von Ersatzmaterial und Wachstfaktor (BMP2) hinsichtlich Wahrnehmung, Knochenquantität und -qualität

E.1.1.2

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Dentistry [E06]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	PT
E.1.2	Classification code	10064143
E.1.2	Term	Dental implantation
E.1.2	System Organ Class	10042613 - Surgical and medical procedures

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Patient's perception
bone quantity
bone quality

Patientenwahrnehmung
Knochenquantität
Knochenqualität

E.2.2

Secondary objectives of the trial

safety and tolerabiltiy (adverse effect, soft tissue, sensitivity) of xenogenic grafting block loaded with BMP2 in comparison with autogenous bone block

Zuverlässigkeit und Ertrag (Komplikationen, Weichgewebssituation, Sensibilität) beim Einsatz von eines xenogenen Blockmaterial in Kombination mit BMP2 im Vergleich mit dem Goldstandard eines Eigenknochentransplantats

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

patients requiring implant therapy for the reconstruction of 1 to 4 missing teeth
patients revealing insufficient bone volume for implant placement

geplante Implantatinseration zur Rekonstruktion von 1 bis 4 Zähnen
insuffizientes Knochenvolumen für Implantatinsertion

E.4

Principal exclusion criteria

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

Schwerwiegende Grunderkrankungen
laufende Medikationen als Kontraindikation einer Implantattherapie
Ungenügendes Knochenvolumen zur Gewinnung eines Eigenknochentransplantates
Schwangerschaft und laufende Stillperiode

E.5 End points

E.5.1

Primary end point(s)

perception of the patient
bone quantity (clinical and radiological evaluation)
bone quality (histological evaluation)

Patientenwahrnehmung
Knochenquantität (klinische und radiologische Beurteilung)
Knochenqualität (histologische Beurteilung)

E.5.1.1

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)

8 Tage nach Knochenaugmentation
4 Monate nach Knochenaufbau (entspricht dem Zeitpunkt der Implantatinsertion imZuge dessen eine Biopsie zur histologische Untersuchung entnommen wird)
16,40,64 Monate nach Knochenaufbau (klinische und radiologische Beurteilung der vorliegenden Knochensituation)

E.5.2

Secondary end point(s)

complications (soft tissue, sensitivity)
adverse effects

Komplikationen (Weichgewebssituation, Sensiblitätsstörungen)
Nebenwirkungen

E.5.2.1

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

8 Tage nach Knochenaugmentation
4 Monate nach Knchenaugmenation (=Implantatinsertion)
16,40,64 Monate nach Knochenaufbau

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Kieferaufbau mit Eigenknochen

Rigde augmentation with autogenous bone

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Switzerland

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

none

Keine

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2013-05-07

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-03-22

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2019-03-15

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