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    Summary
    EudraCT Number:2015-001434-16
    Sponsor's Protocol Code Number:3D_CHB/collacone
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2015-06-30
    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 ConcernedGermany - PEI
    A.2EudraCT number2015-001434-16
    A.3Full title of the trial
    A method for measuring volume changes of the alveolar ridge during
    dental implantation using 3D scanning
    3D-oberflächenscanbasierte Verlaufsmessung der Extraktionsalveole nach
    Alveolenmanagement bei geplanter dentaler Implantation im
    Kieferknochen
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Investigation of the volume stability of the alveolar ridge, the bone
    structure and soft tissue appearance at a delayed dental implantation
    using bone regeneration materials (Human-Spongiosa, gefriergetrocknet,
    CHB; collacone®)
    Untersuchung der Volumenstabilität des Kieferkamms, der
    Knochenstruktur und des Weichgewebeerscheinungsbildes bei einer
    verzögerten dentalen Implantation unter Verwendung von
    Knochenregenerationsmaterial (Human-Spongiosa, gefriergetrocknet, CHB;
    collacone®)
    A.4.1Sponsor's protocol code number3D_CHB/collacone
    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 SponsorUniversitätsmedizin Greifswald, KöR
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBotiss medical AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Medicine Greifswald
    B.5.2Functional name of contact pointOral and Maxillofacial Surgery
    B.5.3 Address:
    B.5.3.1Street AddressWalther-Rathenau-Straße 42-a
    B.5.3.2Town/ cityGreifswald
    B.5.3.3Post code17489
    B.5.3.4CountryGermany
    B.5.4Telephone number00493834867348
    B.5.5Fax number00493834867183
    B.5.6E-mailmksoudm@uni-greifswald.de
    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 Yes
    D.2.1.1.1Trade name Human-Spongiosa, gefriergetrocknet, CHB
    D.2.1.1.2Name of the Marketing Authorisation holderInstitute of Transfusion Medicine, Tissue bank, Charité university of medicine Berlin
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameHuman-Spongiosa, gefriergetrocknet, CHB
    D.3.4Pharmaceutical form Granules
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPDental use
    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 No
    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 Yes
    D.3.11.13.1Other medicinal product typetissue transplant
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    alveolar ridge atrophy
    Alveolarkamm Atrophie
    E.1.1.1Medical condition in easily understood language
    Reduction of jaw bone volume following tooth loss
    Reduktion von Kieferknochenvolumen nach Zahnverlust
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Dentistry [E06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10074846
    E.1.2Term Alveolar bone resorption
    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
    The main objective is to measure the extent of resorption of the alveolar bone following teeth extraction and alveolar management (socket preservation) and to compare the two authorized bone substitute materials:
    (1) Human Spongiosa, gefriergetrocknet, CHB + mucoderm® and
    (2) collacone® + mucoderm® through 3D surface scan.
    Das primäre Ziel ist die Messung des Resorptionsausmaßes des Alveolarknochens nach einer Zahn entfernung und Durchführung eines Alveolenmanagments (socket preservation) und der Vergleich der zugelassenen verwendeten Knochenersatzpräparate (1) Human Spongiosa, gefriergetrocknet, CHB + mucoderm® und (2) collacone® + mucoderm.
    E.2.2Secondary objectives of the trial
    a) Measurement of the implant stability
    b) measurement and visual comparison of the local soft tissues of the gingiva with a definite aesthetic index
    c) visual representation of the bone changes in the augmented area

    Further objective:
    - Investigation of the systemic effects of the used materials through
    laboratory test of the blood and comparing the results with the
    reference population laboratory values (SHIP-Trend)
    a) Messungen der Implantatstabilität
    b) Messungen und visueller Vergleich des lokalen Weichgewebes der Gingiva mit einem definierten Index zur Ästhetik.
    c) Visuelle Repräsentation der Knochenveränderungen im Augmentationsbereich.

    Weiteres Ziel:

    • Untersuchung der systemischen Auswirkungen der eingebrachten
    Materialien durch Laborwertbestimmungen im Blut und mit den auf
    gleiche Weise bestimmten Laborwerten einer
    bevölkerungsrepräsentativen Referenzpopulation (SHIP-Trend)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Signed informed consent
    - Indication for tooth extraction resulting in a edentulous gap
    - Male and female patients with an age range 20-60 years
    - Caucasian
    - For female patients: a negative pregnancy test
    - Normotensive blood pressure (according to the WHO definition):
    * Men: 110/70 – 140/90 mm Hg
    * Women: 100/60- 140/90mm Hg
    - Unterschriebene Einwilligungserklärung
    - Indikation zur Zahnextraktion und sich ergebende Schaltlücke
    - Männliche und weibliche Patienten in Alter von 20 bis 60 Jahren
    - Kaukasier
    - bei Patientinnen: eine negativer Schwangerschaftstest
    - Normotone Blutdruckwerte (gem. WHO- Definition):
    * Männer = 110/70 – 140/90 mm Hg
    * Frauen = 100/60- 140/90mm Hg
    E.4Principal exclusion criteria
    - Parallel implantation of another implant
    - Parallel planned prosthetic restoration of the adjacent teeth
    - Smoker (less than 5 years non-smoker)
    - Nursing women
    - Participation in another clinical trial which dates back to less than 3
    months before inclusion in this clinical trial
    - Intake of bisphosphonates
    - Radiation therapy (medical history or current)
    - Known Diabetes mellitus
    - Inflammatory processes in the mouth (PSI> 2)
    - Presence of autoimmune diseases (Rheumatoid arthritis, Sjögren's
    syndrome, Systemic lupus erythematosus)
    - Presence of blood coagulation disorders (Haemophilia A/B), or the
    intake of anticoagulants (Warfirin, new oral anticoagulants, aspirin>
    100 mg)
    - Osteogenesis imperfecta
    - Osteoporosis
    - Leukemia
    - Agranulocytosis
    - Immunocompromised patients
    - Acute phase and rehabilitation phase of myocardial infarction
    - Oncogenes diseases
    - Patients undergoing chemotherapy
    - Sepsis
    - Acute and chronic infections: sinusitis, rhinitis, pharyngitis and otitis media
    - Wound healing disorders
    - Seizures
    - Gingival hyperplasia
    - Alcohol abuse
    - Drug abuse
    - Infectious diseases (HIV, Hepatitis B and C)
    - Parallele Implantation eines weiteren Implantats
    - Parallel geplante prothetische Versorgung der Nachbarzähne
    - Raucher (weniger als 5 Jahre Nichtraucher)
    - Stillende Frauen
    - Die Teilnahme an einer anderen klinischen Studie, die weniger als 3
    Monate vor Einschluss zurückliegt.
    - Einnahme von Bisphosphonaten
    - Bestrahlungstherapie (anamnestisch oder aktuell)
    - Bekannter Diabetes mellitus
    - Entzündliche Prozesse im Mund (PSI > 2)
    - Vorhandensein von Autoimmunerkrankungen (Rheumatoide Arthritis,
    Sjögren- Syndrom, systemischer Lupus Erythematodes)
    - Vorhandensein von Blutgerinnungsstörungen (Hämophilie A / B), bzw.
    Einnahme gerinnungshemmender Medikamente (Cumarine; neue orale
    Antikoagulantien; ASS > 100 mg)
    - Osteogenesis imperfecta
    - Osteoporose
    - Leukämieerkrankungen
    - Agranulozytosen
    - Immunsupprimierte Personen
    - Akute Phase und Rehabilitationsphase eines myokardialen Infarktes
    - Onkogene Erkrankungen
    - Patienten unter Chemotherapie
    - Sepsis
    - Akute und chronische Infektionen: Sinusitis, Rhinitis, Pharyngitis und Otitis media
    - Wundheilungsstörungen
    - Krampfanfälle
    - Gingivahyperplasie
    - Alkoholabusus
    - Drogenabusus
    - Infektionskrankheiten (HIV, Hepatitis B und C)
    E.5 End points
    E.5.1Primary end point(s)
    The main objective is to measure the extent of resorption of the alveolar bone following teeth extraction and alveolar management (socket preservation) and to compare the two authorized bone substitute materials:
    (1) Human Spongiosa, gefriergetrocknet, CHB + mucoderm® and
    (2) collacone® + mucoderm® through 3D surface scan.
    Das primäre Ziel ist die Messung des Resorptionsausmaßes des Alveolarknochens nach einer Zahn entfernung und Durchführung eines Alveolenmanagments (socket preservation) und der Vergleich der zugelassenen verwendeten Knochenersatzpräparate (1) Human Spongiosa, gefriergetrocknet, CHB + mucoderm® und (2) collacone® + mucoderm.
    E.5.1.1Timepoint(s) of evaluation of this end point
    T -3: before beginning of the study
    T -2: Inclusion examination (< 4 weeks before extraktion and Socket
    Preservation)
    T -1: Preoperative examination (< 1 week before Extraktion and Socket
    Preservation)
    T 0: Extraktion and Socket Preservation
    T 1: 7-10 days after extraktion and Socket Preservation
    T 2: 1 Month after extraktion and Socket Preservation
    T 3: Implantation (4.5 months after extraktion and Socket Preservation)
    T 4: 7-10 days after Implantation
    T 5: 1 month after Implantation
    T 6: 3 months after Implantation
    T 7: 6 months after Implantation
    T 8: 9 months after Implantation
    T -3: Vor Studienbeginn
    T -2: Einschlussuntersuchung (< 4 Wochen vor Extraktion und Socket
    Preservation)
    T -1: Präoperative Untersuchung (< 1 Woche vor Extraktion und Socket
    Preservation)
    T 0: Extraktion und Socket Preservation
    T 1: 7-10 Tage nach Extraktion und Socket Preservation
    T 2: 1 Monat nach Extraktion und Socket Preservation
    T 3: Implantation (4.5 Monate nach Extraktion und Socket Preservation)
    T 4: 7-10 Tage nach Implantation
    T 5: 1 Monat nach Implantation
    T 6: 3 Monate nach Implantation
    T 7: 6 Monate nach Implantation
    T 8: 9 Monate nach Implantation
    E.5.2Secondary end point(s)
    Not applicable
    nicht vorhanden
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not Applicable
    nicht Vorhanden
    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 No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    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 : Examination time point T8 (10.5 months after implantation)
    Letzte Untersuchung des letzten Patienten: Untersuchungszeitpunkt T8
    (10.5 Monate nach Implantation)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 24
    F.1.3Elderly (>=65 years) No
    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 state24
    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)
    After completion of the study (after the last examination time point T8)
    regular check-up visits will be continued as part of the implants
    consultation-hours at the department of Maxillofacial Surgery and
    Plastic Surgery, if it complies with the patient's wishes.
    Nach Abschluss der Studie (nach dem letzten Untersuchungszeitpunkt
    T8) wird die regelmäßige Kontrolle im Rahmen der Implantat-
    Spezialsprechstunde der Poliklinik für Mund-Kiefer-Gesichtschirurgie
    und Plastische Operationen -wenn es dem Patientenwunsch entspricht fortgesetzt.
    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 Decision2016-01-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-03-30
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2023-05-08
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    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
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