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   43874   clinical trials with a EudraCT protocol, of which   7294   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:2019-000902-31
    Sponsor's Protocol Code Number:ECACOR19
    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:2019-07-05
    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 number2019-000902-31
    A.3Full title of the trial
    Healing efficacy after impacted mandibular third molar surgery with the use of autologous platelet-rich fibrin: a randomized controlled clinical study
    Eficacia en la cicatrización tras el uso de L-PRF en la cirugía de tercer molar inferior incluido. Ensayo clínico controlado aleatorizado
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy of a blood derivative (leukocyte and platelet rich fibrin) in healing after extraction of lower wisdom teeth.
    Eficacia de un derivado de la sangre (fibrina rica en plaquetas y leucocitos) en la cicatrización tras la extracción de molares del juicio inferiores.
    A.4.1Sponsor's protocol code numberECACOR19
    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 SponsorOMEQUI
    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 supportOMEQUI
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Santiago de Compostela. Faculty of Medicine and Dentistry
    B.5.2Functional name of contact pointMaster of Periodontics. USC
    B.5.3 Address:
    B.5.3.1Street Addressc/Entrerríos sn
    B.5.3.2Town/ citySantiago de Compostela
    B.5.3.3Post code15782
    B.5.3.4CountrySpain
    B.5.4Telephone number34981562226
    B.5.6E-mailanacastellanoviruleg@gmail.com
    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 nameL-PRF
    D.3.2Product code IS220
    D.3.4Pharmaceutical form Periodontal insert
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPBuccal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLeukocytes and platelet rich fibrin
    D.3.9.2Current sponsor codeIS220
    D.3.9.3Other descriptive namePLASMA
    D.3.9.4EV Substance CodeSUB118891
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number3 to 6
    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
    If the addition of L-PRF reduces postoperative pain and inflammation, as well as complications, after extraction of lower third molars
    Si la adición de L-PRF disminuye el dolor postoperatorio y la inflamación, así como las complicaciones, tras la extracción de terceros molares inferiores
    E.1.1.1Medical condition in easily understood language
    If a blood derivative helps to have less pain, inflammation and complications after removing a lower wisdom tooth
    Si un derivado de la sangre ayuda a tener menos dolor, inflamación y complicaciones después de sacar una muela de juicio inferior
    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
    To evaluate the efficacy of L-PRF placement in post-extraction alveoli when reducing postoperative pain after extraction of lower third molars against natural healing using a visual analogue scale (VAS).
    Evaluar la eficacia de la colocación de L-PRF en alvéolos postextracción a la hora de disminuir el dolor postoperatorio tras la extracción de terceros molares inferiores frente a la cicatrización natural mediante una escala analógica visual (EVA).
    E.2.2Secondary objectives of the trial
    Evaluate the level of inflammation using the Pasqualini index, the level of healing using the Landry index, the possible complications (osteitis, trismus, ...) and the number of analgesics needed.
    Evaluar el nivel de inflamación mediante el índice de Pasqualini, el nivel de cicatrización mediante el índice de Landry, las posibles complicaciones (osteítis, trismus,…) y número de analgésicos necesarios.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients> 18 years.
    Presence of oral health (periodontally healthy or with treated periodontitis), with a BoP <20% and a PI <20%.
    Systemically healthy, without any disease that may contraindicate minor oral surgery, that does not take any medication that may influence coagulation and / or that takes any NSAID or paracetamol daily.
    Non-smokers or smokers of <10 cigarettes/day.
    No pregnancy or lactation.
    The tooth to be extracted will be included or semi-included and will have fully formed roots.
    Absence of infectious and cystic pathology in the molar to be extracted.
    Pacientes >18 años.
    Presencia de salud oral (periodontalmente sanos o con periodontitis tratada), con un BoP <20% y un PI <20%.
    Sistémicamente sanos, sin ninguna enfermedad que pueda contraindicar una cirugía oral menor, que no tome ningún medicamento que pueda influir en la coagulación y/o que tome diariamente algún AINE o paracetamol.
    No fumadores o fumadores de <10 cigarrillos/día.
    No embarazo ni lactancia.
    El diente a extraer será incluido o semiincluido y tendrá las raíces totalmente formadas.
    Ausencia de patología infecciosa y quística en el molar a extraer.
    E.4Principal exclusion criteria
    Patients who due to systemic conditions are not possible to draw blood.
    Penicillin allergy.
    Allergy to ibuprofen and / or paracetamol.
    Diseases that limit the use of ibuprofen and / or paracetamol.
    Pacientes que por condiciones sistémicos no sea posible la extracción de sangre.
    Alergia a la penicilina.
    Alergia al ibuprofeno y/o paracetamol.
    Enfermedades que limiten el uso de ibuprofeno y/o paracetamol.
    E.5 End points
    E.5.1Primary end point(s)
    Intensity of postoperative pain measured by an Analog Visual Scale
    Intensidad del dolor postoperatorio medido mediante una Escala Visual Analógica
    E.5.1.1Timepoint(s) of evaluation of this end point
    At 1, 2, 3, 4, 5, 6 and 7 day
    A los 1, 2, 3, 4, 5, 6 y 7 días
    E.5.2Secondary end point(s)
    Inflammation level according to Pasqualini's Visual scale.
    Level of healing according to the Landry index.
    Postoperative complications: trismus and / or osteitis.
    Number of analgesic pills needed.
    Nivel de inflamación según la escala Visual de Pasqualini.
    Nivel de cicatrización según el índice de Landry.
    Complicaciones postoperatorias: trismus y/o osteítis.
    Número de pastillas analgésicas necesarias.
    E.5.2.1Timepoint(s) of evaluation of this end point
    7 day
    día 7
    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 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 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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Cicatrización natural
    Natural healing
    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 years
    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: 36
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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
    Ninguno
    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 Decision2019-09-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-03
    P. End of Trial
    P.End of Trial StatusOngoing
    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-Thu May 16 10:34:19 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA