E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Peri-implantitis |
Periimplantitis |
|
E.1.1.1 | Medical condition in easily understood language |
Peri-implantitis |
Periimplantitis |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Bacterial Infections and Mycoses [C01] |
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 |
Evaluate the radiographic changes after treatment with Metronidazole as an adjunct to non-surgical treatment at implants diagnosed of peri-implantitis. |
Evaluar los cambios radiográficos de la administración de metronidazol sistémico junto con el tratamiento no quirúrgico de la periimplantitis frente a la administración coadyuvante de un placebo. |
|
E.2.2 | Secondary objectives of the trial |
Evaluate the clinical and microbiological changes after treatment with Metronidazole as an adjunct to non-surgical treatment at implants diagnosed of peri-implantitis. |
Evaluar los cambios clínicos y microbiológicos de la administración de metronidazol sistémico junto con el tratamiento no quirúrgico de la periimplantitis frente a la administración coadyuvante de un placebo |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Older than 18 years. Presence of at least 1 implant diagnosed with peri-implantitis (Presence of BOP and/or suppuration, with 2 mm of detectable bone loss after initial remodeling, and PD 4 mm as defined by Daubert et al. 2015). Absence of implant mobility. History of taking systemic antibiotics in the preceding 3 months.
• No systemic pathology that contraindicated the completion of treatment.
• The patient understands the treatment and willing to comply.
• The patient is willing to give written informed consent and can do. |
Mayor de 18 años. Presencia de al menos 1 implante diagnosticado de periimplantitis (Presencia de pérdida ósea detectable de 3 mm, profundidad de sondaje 6 mm y sangrado y/o supuración de acuerdo a la definición de Daubert y cols. 2015). Al menos 1 año después de colocación de restauración definitiva Ausencia de movilidad del implante. No haber consumido antibióticos en 3 meses previos. No patología sistémica que contraindique la realización del tratamiento. |
|
E.4 | Principal exclusion criteria |
Pregnant. Metronidazole allergies Patients on treatment with bisphosphonates. Uncontrolled periodontal disease. |
Embarazadas. Alergias a metronidazol. Pacientes a tratamiento con bifosfonatos. Enfermedad periodontal no controlada. Fumadores de más de 20 cigarros/día. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Radiographic peri-implant bone level changes |
Cambios en el nivel óseo radiográfico |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Two and six months after treatment |
Dos y seis meses después del tratamiento |
|
E.5.2 | Secondary end point(s) |
Changes in clinical and microbiological (presence of pathogens and bacterial load) parameters |
Cambios en los parámetros clínicos (profundidad de sondaje) y microbiológicos (presencia de patógenos y carga bacteriana) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Two and six months after treatment |
Dos y seis meses después del tratamiento |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
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 |
Ultima visita. Ultimo sujeto. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | |