Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44416   clinical trials with a EudraCT protocol, of which   7423   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2021-006891-18
    Sponsor's Protocol Code Number:GR-OG-279239-05
    National Competent Authority:Croatia - MIZ
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2026-10-26
    Trial 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
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedCroatia - MIZ
    A.2EudraCT number2021-006891-18
    A.3Full title of the trial
    Efficacy, safety and tolerability of a single dose of Osteogrow (recombinant human bone morphogenetic protein 6 in autologous blood coagulum) in alveolar ridge regeneration following tooth extraction
    'Učinkovitost, sigurnost i podnošljivost jednokratne doze OSTEOGROW-a (rekombinantni humani koštani morfogenetski protein 6 u autolognom krvnom ugrušku) u regeneraciji alveolarnog grebena nakon vađenja zuba
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Blinded study on efficacy, safety and tolerability of a single dose of rhBMP6 mixed with patient's own blood in bone formation after tooth extraction
    A.4.1Sponsor's protocol code numberGR-OG-279239-05
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGenera Research Ltd
    B.1.3.4CountryCroatia
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportGenera Research Ltd
    B.4.2CountryCroatia
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Zagreb School of Medicine
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressŠalata 3
    B.5.3.2Town/ cityZagreb
    B.5.3.3Post code10000
    B.5.3.4CountryCroatia
    B.5.4Telephone number3851 4566 812
    B.5.6E-mailslobodan.vukicevic@mef.hr
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameOsteogrow
    D.3.2Product code rhBMP6
    D.3.4Pharmaceutical form Powder and solvent for implantation paste
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPImplantation
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot yet available
    D.3.9.2Current sponsor coderhBMP6
    D.3.9.3Other descriptive nameRECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN 6
    D.3.9.4EV Substance CodeSUB176170
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboPowder and solvent for implantation paste
    D.8.4Route of administration of the placeboImplantation
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Single tooth extraction in maxilla or mandible.
    E.1.1.1Medical condition in easily understood language
    Single tooth extraction in maxilla or mandible.
    E.1.1.2Therapeutic area Diseases [C] - Mouth and tooth diseases [C07]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 26.1
    E.1.2Level PT
    E.1.2Classification code 10034536
    E.1.2Term Periodontal disease
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of Osteogrow as an extraction socket filling material and its ridge preservation and regeneration properties in patients after flapless tooth extraction
    E.2.2Secondary objectives of the trial
    To evaluate the safety and tolerability of Osteogrow after flapless tooth extraction
    To evaluate the overall clinical outcome after socket preservation with Osteogrow that would allow implant placement
    To evaluate the effects of study treatments on patient’s level of pain and oral health impact
    Need to perform additional bone grafting during implant placement.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients meeting ALL of the following criteria at screening will be eligible for participation in the study:
    1. Willing and able to provide informed consent and to comply with study requirements. Written informed consent must be obtained before any study assessments are done.
    1. Patients must be fluent in the language that is spoken by the investigator and the trial staff and in which the informed consent is written.
    2. Age ≥18 years.
    3. Systemically healthy
    4. Patient in need of single tooth extraction in the maxilla or mandible.
    E.4Principal exclusion criteria
    Patients meeting ANY of the following criteria at screening will NOT be
    eligible for participation in the study:
    1. Nontreated periodontal disease.
    2. Smoking more than 10 cigarets per day.
    3. Previous treatment with bone morphogenetic proteins (e.g. rhBMP7 or rhBMP2).
    4. Presence of active malignancy or prior history of malignancy (except for basal cell carcinoma of the skin).
    5. Patients receiving radiation, chemotherapy, corticosteroids, immunosuppressive therapy.
    6. Previous diagnosis of osteomalacia.
    7. Patients with a known autoimmune disease.
    8. Participation in clinical study within 6 months prior to surgery.
    9. Conditions that require postoperative medications that interfere with fusion, such as steroids or prolonged use of non-steroidal anti-inflammatory drugs, including routine perioperative non-steroidal anti-inflammatory drugs (except Metamizole which is allowed).
    10. Pregnant and lactating.
    11. Treatment with systemic corticosteroids within 1 week prior to surgery and postoperatively for 5 months, or with immunosuppressants (e.g., methotrexate) within 2 weeks prior to surgery.
    12. Patient is a known drug or alcohol abuser.
    E.5 End points
    E.5.1Primary end point(s)
    The incidence of clinical success at 5 months after the surgery, where clinical success is defined as:
    • Gain of vertical bone height (buccal and lingual) as measured by the CBCT
    • Gain of bone socket width as measured by the CBCT
    • Greater socket bone fill as measured by the CBCT
    E.5.1.1Timepoint(s) of evaluation of this end point
    All patients will undergo the same subsequent protocol procedures. The first post-operative radiological assessment is planned within 24 hours after drug administration (or surgery) by CBCT (Cone Beam Computer Tomography). In terms of the safety assessment regarding Osteogrow administration, the month 5 assessment will serve the purpose of determination of the bone regeneration and bone fill in the extraction sockets following tooth extraction. Patients will be evaluated preoperatively, intra-operatively, and followed postoperatively day 1, 14 and months 1 and 5. CBCT images and analysis will be done within 24 hours after the surgery and after 5 months. Success outcome will be determined from data collected during the 5 months of the follow-up.
    E.5.2Secondary end point(s)
    • The incidence of clinical success at 5 months after the surgery.
    • Percentage of socket bone fill
    • The level postoperative pain sensation (NRS)
    • No need for an additional bone regenerative surgical procedure at surgical site
    E.5.2.1Timepoint(s) of evaluation of this end point
    ll patients will undergo the same subsequent protocol procedures. The first post-operative radiological assessment is planned within 24 hours after drug administration (or surgery) by CBCT (Cone Beam Computer Tomography). In terms of the safety assessment regarding Osteogrow administration, the month 5 assessment will serve the purpose of determination of the bone regeneration and bone fill in the extraction sockets following tooth extraction. Patients will be evaluated preoperatively, intra-operatively, and followed postoperatively day 1, 14 and months 1 and 5. CBCT images and analysis will be done within 24 hours after the surgery and after 5 months. Success outcome will be determined from data collected during the 5 months of the follow-up.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    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.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months8
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 6
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state36
    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
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-09-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-06-17
    P. End of Trial
    P.End of Trial StatusCompleted
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sat Nov 07 12:12:01 CET 2026 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA