E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Healthy volunteers (Postoperative infections and dental implant failures) |
Voluntarios sanos (infecciones postoperatorias y fracasos de implantes dentales) |
|
E.1.1.1 | Medical condition in easily understood language |
Healthy volunteers (Postoperative infections and dental implant failures) |
Voluntarios sanos (infecciones postoperatorias y fracasos de implantes dentales) |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Mouth and tooth diseases [C07] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess wheather a single dose of 600 mg clindamycin hydrochloride (2 hard capsules of 300 mg orally) one hour before surgery is effective, against placebo, in reducing the frequency of failures and infections after the insertion of dental implants. |
Evaluar si una dosis única de clorhidrato de clindamicina de 600 mg (2 cápsulas duras de 300 mg por vía oral) una hora antes de la cirugía es efectiva, en comparación con placebo, para reducir la frecuencia de fracasos e infecciones después de la inserción de implantes dentales. |
|
E.2.2 | Secondary objectives of the trial |
Assess the incidence of adverse effects related to the use of clindamycin hydrochloride |
Evaluar la incidencia de efectos adversos relacionados con el uso de clorhidrato de clindamicina |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Healthy subjects over the age of 18, without discrimination on the basis of sex or race, who will be given a single implant and who, once informed, will sign a consent form to participate in the trial. |
Sujetos sanos mayores de 18 años, sin discriminación de sexo o raza, a los que se les colocará un solo implante y que, una vez informados, firmarán un formulario de consentimiento para participar en el ensayo. |
|
E.4 | Principal exclusion criteria |
Pre-randomisation exclusion criteria: patients allergic to amoxicillin, patients who had taken antibiotics for any reason during the 15 days prior to surgery, patients with decompensated systemic pathologies: cardiac, respiratory, endocrine, metabolic, hepatic, haematological, risk of bacterial endocarditis, immunosuppressed, with valvular and orthopedic prostheses in treatment with bisphosphonates, anticoagulants and platelet antiaggregants and those with allergy to any of the drugs used in the trial. Irradiated patients in the cervical-maxillofacial territory. Pregnant women, women suspected of being pregnant or breastfeeding. Patients with a history of antibiotic-associated colitis. Post-randomisation exclusion criteria. At the request of the patient with abandonment of the trial or loss of follow-up. |
Criterios de exclusión de la preasignación al azar: pacientes alérgicos a la amoxicilina, pacientes que habían tomado antibióticos por cualquier motivo durante los 15 días anteriores a la cirugía, pacientes con patologías sistémicas descompensadas: cardiacos, respiratorios, endocrinos, metabólicos, hepáticos, hematológicos, riesgo de endocarditis bacteriana, inmunosuprimidos, con prótesis valvulares y ortopédicas en tratamiento con bifosfonatos, anticoagulantes y antiagregantes plaquetarios y alérgicos a cualquiera de los fármacos utilizados en el ensayo. Pacientes irradiados en el territorio cérvico-maxilofacial. Mujeres embarazadas, mujeres sospechosas de estar embarazadas o en período de lactancia. Pacientes con antecedentes de colitis asociada a antibióticos. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Incidence rate of posoperative infection and/or dental implant failure equal to 0% |
Tasa de incidencia de infección postoperatoria y/o fracaso del implante dental igual al 0%. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
8 weeks follow-up after surgery |
8 semanas de seguimiento después de la cirugía |
|
E.5.2 | Secondary end point(s) |
Not applicable |
No aplicable |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Not applicable |
No aplicable |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial 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 sujeto |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |