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    Summary
    EudraCT Number:2019-001167-75
    Sponsor's Protocol Code Number:FIBEA-04-EC-19-ALV
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-06-11
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2019-001167-75
    A.3Full title of the trial
    Randomized Clinical Trial, conventional treatment-controlled, studying the efficacy of Plasma Rich in Growth Factor (PRGF®) in alveolar ridge preservation after simple exodontia in the anterior region of maxilla.
    Ensayo clínico, aleatorizado, controlado con tratamiento convencional, de eficacia del Plasma Rico en Factores de Crecimiento (PRGF®) en la preservación del reborde después de las exodoncias simples en la zona anterior de la maxila.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomized Clinical Trial, conventional treatment-controlled, studying the efficacy of Plasma Rich in Growth Factor (PRGF®) in alveolar ridge preservation after simple exodontia in the anterior region of maxilla.
    Ensayo clínico, aleatorizado, controlado con tratamiento convencional, de eficacia del Plasma Rico en Factores de Crecimiento (PRGF®) en la preservación del reborde después de las exodoncias simples en la zona anterior de la maxila.
    A.4.1Sponsor's protocol code numberFIBEA-04-EC-19-ALV
    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 SponsorBTI I MAS D
    B.1.3.4CountrySpain
    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 supportBTI I MAD D
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBTI I mas D
    B.5.2Functional name of contact pointClinical Affairs
    B.5.3 Address:
    B.5.3.1Street AddressC/ Jacinto Quincoces, 39
    B.5.3.2Town/ cityVitoria-Gasteiz
    B.5.3.3Post code01007
    B.5.3.4CountrySpain
    B.5.6E-mailsofia.fernandez@bti-implant.es
    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 namePRP Obtained by PRGF-Endoret
    D.3.4Pharmaceutical form Gel
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPPeriodontal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPlatelet concentrate
    D.3.9.3Other descriptive namePLATELET CONCENTRATE
    D.3.9.4EV Substance CodeSUB14918MIG
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 Yes
    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 No
    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 preservation after exodontia of uniradiculate dental pience in the anterior region of maxilla
    Preservación alveolar tras exodoncia de pieza dental uniradicular en la zona anterior de la maxila
    E.1.1.1Medical condition in easily understood language
    Alveolar ridge preservation after exodontia of uniradiculate dental pience in the anterior region of maxilla
    Preservación alveolar tras exodoncia de pieza dental uniradicular en la zona anterior de la maxila
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Dentistry [E06]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate the efficacy of Plasma Rich in Growth Factors (PRGF®) in alveolar ridge preservation after simple exodontia of uniradiculate dental piece in the anteiror region of the maxilla
    Evaluar la eficacia del Plasma Rico en Factores de Crecimiento (PRGF®) en la preservación del reborde alveolar después de la extracción simple de en la zona anterior de la maxila.
    E.2.2Secondary objectives of the trial
    Not applicable
    No aplica
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Subjects of both sexes with an age greater than or equal to 18 years.
    - Clinical indication for a simple exodontia of a uniradicular tooth in the superior maxilla
    - Availability to follow-up during the treatment period
    - Subjects with non-active periodontal disease.
    - Buccal dehiscence < than 25% in the vestibular table
    - Signing the informed content
    • Sujetos mayores de edad de ambos sexos.
    • Indicación de exodoncia simple de un diente uniradicular en el maxilar superior.
    • Posibilidad para observación durante el periodo de tratamiento.
    • Pacientes con enfermedad periodontal no activa.
    • Dehiscencia bucal < 25% de la tabla vestibular.
    • Firma del consentimiento informado
    E.4Principal exclusion criteria
    Presence of an active infection
    - Loss of any plate of the socket
    - Severe inflammation in the area of the exodontia previous to the intervention
    - Suffer any severe hematologic disease o disorder
    - Have received radiotherapy, chemotherapy or immunosuppressive treatments, systemic corticosteroids and/or anticoagulants the 30 days prior to inclusion
    - Regular treatment with AINES or other antiinflammatory drugs
    - Previous history of chronic hepatitis or heatic cirrhosis
    - Uncontrolled diabetes mellitus (Glycosylated hemoglobin higher than 9%)
    - Subjects submitted to hemodyalisis
    - Presence of malignant tumour, haemangiomas or angioma in the exodontia region.
    - Previous history of ischemic cardiopathy in the last year.
    - Pregnancy or womens in childbearing age who do not take contraception measures.
    - Nursing womens
    - Metabolic bone disease
    - Ongoing treatment with biphosphonates both through oral or intravenous administration
    - Smoking habits (> 10 cigarrettes/day)
    - In general, any disability to participate in the study
    • Presencia de infección activa.
    • Perdida de alguna pared ósea del alveolo.
    • Inflamación severa previa a la intervención en las áreas destinadas para la exodoncia.
    • Sufrir alteración o enfermedad hematológica grave.
    • Estar siendo sometido o haber recibido los 30 días anteriores a la inclusión radioterapia, quimioterapia o tratamientos inmunosupresores, corticoides sistémicos y/o anticoagulantes.
    - Hábito tabaquismo (> 10 cigarrillos/día)
    • En tratamiento habitual con AINES u otros fármacos antiinflamatorios.
    • Antecedentes de hepatitis crónica o cirrosis hepática.
    • Diabetes mellitus con mal control metabólico (hemoglobina glicosilada superior al 9%)
    • Pacientes sometidos a diálisis.
    • Presencia de tumores malignos, hemangiomas o angiomas en la zona de extracción.
    • Antecedentes de cardiopatía isquémica en el último año.
    • Embarazo o mujeres en edad fértil que no tomen medidas anticonceptivas
    • Enfermedad ósea metabólica.
    - Mujeres lactantes
    • Pacientes en tratamiento con fármacos bifosfonatos tanto por vía oral como intravenosa.
    • En general, cualquier incapacidad para participar en el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Bone formation evaluated by histomorphometric analysis of the biopsies
    Formación ósea evaluada mediante el análisis histomorfométrico de las biopsias
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks after exodontia
    12 semanas tras la exodoncia
    E.5.2Secondary end point(s)
    1- Dimensional changes in the alveolar ridge measured by superimposition of the digital archives of the plaster cast
    2- Dimensional bone changes in the alveolar ridge measured by CBCT usin the BTI scan software.
    3- Bone density mesured in Hounsfield units measured in 3 points after analysis using BTI scan
    4- Alveolar ridge width mesuared with periodontal probe.
    5- Measures using periodontal probe. Vertical measures from the top of the mouthguard to the first bone-contact in the center of the vestibular and lingual tables and to the mesiobucal, distobucal, mesiolingual and distolingual points.
    6- Pain during the recent post-surgery mesuared with the visual analogue scale (VAS).
    7- Laundry Soft-tissue healing scale
    8- Inflammation with the following ordinal scale:
    0. Absence of inflammation
    1. Slight swelling and hardness without facial planes blurring.
    2. Facial planes blurring without affectation of nasolabial folds or eyes.
    3. Facial planes blurring with affectation of nasolabial folds and eyes.
    1-Cambios en las dimensiones del reborde alveolar mediante la superimposición de los archivos digitales de los modelos de escayola
    2- Cambios en las dimensiones óseas del reborde alveolar medidos mediante el análisis del CBCT con el software BTI Scan.
    3-Densidad ósea en unidades Hounsfield determinada en 3 puntos tras análisis mediante el software BTI Scan
    4- Medida de la anchura ósea con sonda periodontal
    5- Medidas verticales entre el tope de la férula y los puntos óseos situados en el centro de las tablas vestibular y lingual y en los puntos mesiobucal, distobucal, mesiolingual y distolingual. Las medidas se realizarán con sonda periodontal.
    6- Dolor durante el postoperatorio reciente ) medido mediante escala analógico visual (EAV).
    7- Índice de curación de los tejidos blandos de Laundry
    8- Inflamación atendiendo a la siguiente escala ordinal: (Escala de 0 a 3):
    0. Ausencia de inflamación.
    1. Ligera tumefacción y dureza sin desdibujamiento de planos superficiales faciales.
    2. Desdibujamiento de planos faciales sin afectación de pliegues nasogenianos ni afectación ocular.
    3. Desdibujamiento de planos con afectación de pliegues nasogenianos y afectación ocular.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1- After the exodontia and 12 weeks after
    2- After the exodontia and 12 weeks after
    3- 12 weeks after exodontia
    4- After exodontia, 3 and 7 days after and 12 weeks after
    5- After exodontia, 3 and 7 days after and 12 weeks after
    6- 3, 7 and 15 days after exodontia
    7- 3, 7 and 15 days after exodontia and 4 weeks after exodontia
    8- 3, 7 and 15 days after exodontia
    1- Tras la exodoncia y 12 semanas tras la exodoncia.
    2- Tras la exodoncia y 12 semanas tras la exodoncia.
    3- A las 12 semanas
    4- Tras la exodoncia, a los 3 días, a los 7 días y a las 12 semanas
    5- Tras la exodoncia, a los 3 días, a los 7 días y a las 12 semanas
    6- 3, 7 y 15 días tras la extracción
    7- 3, 7, 15 días tras la extracción y a la semana 4 tras la extracción
    8: 3, 7 y 15 días tras la extracción.
    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 No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Sutura de la herida superior tal y como se hace en la práctica clínica habitual
    Suture of the superior wound as done in the clinical standard practice
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    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
    La última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    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: 56
    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 state62
    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
    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 Decision2019-09-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-06-21
    P. End of Trial
    P.End of Trial StatusOngoing
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