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    Summary
    EudraCT Number:2021-001885-40
    Sponsor's Protocol Code Number:Syst-AB+Sinus
    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:2024-12-03
    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 number2021-001885-40
    A.3Full title of the trial
    The effect of systemic antibiotics on post-surgical complications and paitent-centered outomes in patients undergoing implant surgery with the guided bone regeneration and simultaneous sinus floor elevation.
    Efecto de antibióticos sistémicos en complicaciones post-quirúrgicas y variables relacionadas con el paciente en pacientes sometidos a cirugía de colocación de implantes con regeneración ósea simultánea y elevación de seno simultánea
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of systemic antibiotics after implant surgery with sinus floor elevation.
    Efecto de antibióticos sistémicos tras la colocación de implantes con elevación de seno.
    A.4.1Sponsor's protocol code numberSyst-AB+Sinus
    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 SponsorUniversidad Complutense de Madrid
    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 supportITI Foundation
    B.4.2CountrySwitzerland
    B.4.1Name of organisation providing supportETEP research group
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversidad Complutense de Madrid
    B.5.2Functional name of contact pointMaster de Periodoncia
    B.5.3 Address:
    B.5.3.1Street AddressPza Ramón y cajal s/n
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28040
    B.5.3.4CountrySpain
    B.5.4Telephone number0034913942021
    B.5.5Fax number0034913942021
    B.5.6E-mailmarianosanz@odon.ucm.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 Yes
    D.2.1.1.1Trade name Amoxicilina 500 mg
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratorios Normon S.A
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 typeAntibiotic
    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 placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    The medical condition that the patients have in this trial is edentulism in a posterior maxillary quadrant of the mouth with a sinus pneumatisation/ decreased crestal bone heigh defect requiring augmentation and rehabilitation with 1-3 implants. We want to investigate the effect of amoxicillin after this procedure in terms of complications and patient-centered outcomes.
    La condición médica que tienen los pacientes en este ensayo es edentulismo en un cuadrante maxilar posterior de la boca con un defecto de neumatización del seno / disminución de la altura del hueso crestal que requiere aumento y rehabilitación con 1-3 implantes. Queremos investigar el efecto de la amoxicilina después de este procedimiento en términos de complicaciones y variables relacionadas con el paciente.
    E.1.1.1Medical condition in easily understood language
    edentulism in a posterior maxillary quadrant requiring bone augmentation procedures and implant placement.We aim to investigate the effect of amoxicillin after this procedure.
    edentulismo en un sextante maxilar posterior que requiere procedimientos de aumento óseo y colocación de implantes. Nuestro objetivo es investigar el efecto de la amoxicilina tras este procedimiento.
    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 effect of systemic antibiotic administration compared to placebo in patients undergoing oral implant therapy with simultaneous lateral sinus floor elevation and guided bone regeneration (GBR) in regard to patient-centered outcomes.
    Evaluar el efecto de la administración sistémica de antibióticos en comparación con el placebo en pacientes sometidos a tratamiento con implantes orales con elevación simultánea del suelo del seno (técnica lateral) y regeneración ósea guiada (ROG) con respecto a las variables relacionadas con el paciente.
    E.2.2Secondary objectives of the trial
    To evaluate the effect of systemic antibiotic administration on postsurgical complications, in patients undergoing oral implant therapy with simultaneous lateral approach sinus floor elevation and guided bone regeneration (GBR).
    Evaluar el efecto de la administración de antibióticos sistémicos sobre las complicaciones posquirúrgicas, en pacientes sometidos a terapia de implantes orales con elevación simultánea del seno por abordaje lateral y regeneración ósea guiada (ROG).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Medically healthy adult (ASA classification I-II), age ≥ 21 years old
    2. Non-smoker, previous smoker (quit ≥ 5 years); light smoker with less than 10 cigarettes/ day
    3. Not allergic to Amoxicillin/Penicillin antibiotics, NSAIDS or corn-starch
    4. Edentulous spaces in the posterior maxilla in one or 2 posterior quadrants with an alveolar bone defect requiring sinus floor elevation and allowing implant placement of up to 3 dental implants and simultaneous GBR (residual crest height 3-5 mm; per implant site (Felice et al. 2012; Park et al. 2019).
    5. Absence of signs of pathology of the sinus membrane and acute sinusitis requiring ongoing management
    1. Adulto médicamente sano (clasificación I-II de la ASA), edad ≥ 21 años
    2. No fumador, ex-fumador (dejó de fumar ≥ 5 años); fumador leve con menos de 10 cigarrillos / día
    3. No es alérgico a los antibióticos Amoxicilina / Penicilina, AINE o almidón de maíz
    4. Espacios edéntulos en el maxilar posterior en uno o 2 cuadrantes posteriores con un defecto óseo alveolar que requiere elevación sinusal y permite la colocación de hasta 3 implantes dentales con regeneración ósea simultánea (altura de la cresta residual 3-5 mm; por sitio de implante (Felice et al.2012; Park et al.2019).
    5. Ausencia de signos de patología de la membrana sinusal y sinusitis aguda que requieran tratamiento continuo.
    E.4Principal exclusion criteria
    1. Medically compromised subjects (ASA classification III-V)
    2. General contraindications against implant treatment or augmentative procedures (e.g. immunodeficiency, advanced systemic diseases, corticosteroid medication)
    3. Those taking Bisphosphonates/anti-angiogenic/RANKL inhibitor medications or receiving local radio-therapy
    4. Heavy smoker or previous heavy smoker (quit < 5 years; ≥ 10 cigarettes/day)
    5. Allergic to Amoxicillin or Penicillin antibiotics, NSAIDS and / or corn starch
    6. Use of any form of antibiotics in the last 3 months or subjects requiring regular antibiotic prophylaxis prior to dental treatment
    7. Pregnant or breast feeding. Self-declared intend to conceive (A pregnancy test will be performed for all female patients).
    8. Need for 2 stage sinus augmentation
    9. Acute or unmanaged symptomatic sinusitis
    10. Type 1 implant placement (immediate implant placement following extraction)
    11. Need for simultaneous soft tissue augmentation
    12. Residual bone height of > 5mm.
    13. Subjects aged < 21 years old
    1. Sujetos con problemas médicos (clasificación III-V de la ASA)
    2. Contraindicaciones generales contra el tratamiento con implantes o procedimientos de aumento óseo (por ejemplo, inmunodeficiencia, enfermedades sistémicas avanzadas, medicación con corticosteroides)
    3. Aquellos que toman bisfosfonatos / anti-angiogénicos / inhibidores de RANKL o que reciben radioterapia local.
    4. Fumador de ≥ 10 cigarrillos / día; ex-fumador <5 años.
    5. Alérgico a los antibióticos amoxicilina o penicilina, AINE y / o almidón de maíz
    6. Uso de cualquier forma de antibióticos en los últimos 3 meses o sujetos que requieran profilaxis antibiótica regular antes del tratamiento dental.
    7. Embarazada o en periodo de lactancia. Intención declarada de concebir (se realizará una prueba de embarazo a todas las pacientes).
    8. Necesidad de un aumento de seno en 2 fases (colocación diferida del implante)
    9. Sinusitis sintomática aguda o no tratada
    10. Colocación del implante de tipo 1 (colocación inmediata del implante después de la extracción)
    11. Necesidad de un aumento simultáneo de tejidos blandos
    12. Altura del hueso residual> 5 mm.
    13. Sujetos menores de 21 años
    E.5 End points
    E.5.1Primary end point(s)
    Patient Reported Outcome Measures (PROMs): Visual analogue scores VAS on the wound (pain, swelling, bruising (haematoma), bleeding) and discomfort of the sinuses (nosebleed, nasal congestion, rhinorrhea (excessive nasal discharge including posterior nasal drip), feeling of pressure, hyposmia (reduction in smell)
    Variables relacionadas con el paciente (PROM): puntuaciones analógicas visuales (VAS) en la herida (dolor, hinchazón, hematomas, sangrado) y malestar de los senos (hemorragia nasal, congestión nasal, rinorrea (secreción nasal excesiva que incluye goteo nasal posterior), sensación de presión, hiposmia (reducción del olfato)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline - 2 weeks after surgery- 4 weeks after surgery- 16 to 20 weeks after surgery- moment of crown installation- 6 months after crown installation
    Baseline - 2 semanas después de la cirugía - 4 semanas después de la cirugía - 16 a 20 semanas después de la cirugía - momento de la instalación de la corona - 6 meses después de la instalación de la corona
    E.5.2Secondary end point(s)
    Clinical recordings of post-surgical complications: flap closure/dehiscence, purulent discharge, swelling and implant stability and early implant loss.
    Registros clínicos de complicaciones posquirúrgicas: cierre / dehiscencia del colgajo, secreción purulenta, hinchazón y estabilidad del implante y pérdida temprana del implante.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline - 2 weeks after surgery- 4 weeks after surgery- 16 to 20 weeks after surgery- moment of crown installation- 6 months after crown installation
    Baseline - 2 semanas después de la cirugía - 4 semanas después de la cirugía - 16 a 20 semanas después de la cirugía - momento de la instalación de la corona - 6 meses después de la instalación de la corona
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy No
    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) 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 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 Yes
    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
    With the increasing development of antibiotic resistance due to indiscriminate usage, the use of antibiotics with implant therapy and guided bone regeneration should be re-evaluated.
    The use of antibiotics as prophylaxis against postsurgical infection has been documented. However, in implant dentistry, the use of antibiotics remains a controversial issue, with various antibiotic regimes being advocated. Some authors, however, did not find benefits with their use when compared to controls.
    Con el creciente desarrollo de resistencia a los antibióticos por su uso indiscriminado, se debe reevaluar su uso en terapia de implantes y regeneración ósea guiada.
    Se ha documentado el uso de antibióticos como profilaxis contra la infección posquirúrgica. Sin embargo, en la implantología, el uso de antibióticos sigue siendo un tema controvertido, recomendándose varios regímenes de antibióticos. Sin embargo, algunos autores no encontraron beneficios en su uso en comparación con controles.
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state30
    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)
    Patients will be followed up to 6 months after crown installation. Then, as patients of the Dentistry Faculy, they will enter in a periodontal supportive therapy program.
    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 Decision2022-02-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-11-26
    P. End of Trial
    P.End of Trial StatusOngoing
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