E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with a diagnosis of periodontitis: There is interdental LCI in two or more non-adjacent teeth, or two or more teeth have a vestibular LCI ≥ 3 with a PD > 3 mm |
Pacientes con diagnóstico de periodontitis: Hay PIC interdental en dos o más dientes no adyacentes, o dos o más dientes tienen un PIC vestibular ≥ 3 con una PS> 3 mm |
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E.1.1.1 | Medical condition in easily understood language |
Patients diagnosed with periodontitis, who have pockets deeper than normal |
Pacientes diagnosticados de periodontitis, que presentan bolsas de profundidad superior a la normal |
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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 |
Study the relationship between periodontal disease and the level of ultra sensitive Reactive C Protein and Fibrinogen. |
Estudio sobre la relación entre la enfermedad periodontal y el nivel de Proteína C Reactiva ultrasensible y de Fibrinógeno. |
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E.2.2 | Secondary objectives of the trial |
1. Establish the relationship between the different clinical variables of the periodontal study, with the value of PCRus 2. To establish the relationship between the different clinical variables of the periodontal study, with the serum level of Fibrinogen. 3. To establish the relationship between the different clinical variables of the periodontal study before and after the non-surgical periodontal treatment, and the serum levels of CRP and Fibrinogen. 4. To quantify the impact of the use of topical Doxycycline, as an adjuvant medication for periodontal treatment, on the serum levels of CRP and Fibrinogen. 5. Quantify the impact of the patient's profile, determined by the confounding variables, on the serum levels of CRP and Fibrinogen. |
1. Establecer la relación entre las distintas variables clínicas del estudio periodontal, con el valor de PCRus 2. Establecer la relación entre las distintas variables clínicas del estudio periodontal, con el nivel sérico de Fibrinógeno. 3. Establecer la relación entre las distintas variables clínicas del estudio periodontal antes y después del tratamiento periodontal no quirúrgico, y los niveles séricos de PCRus y de Fibrinógeno. 4. Cuantificar el impacto que tiene la utilización de Doxiciclina tópica, como medicación adyuvante del tratamiento periodontal, en los niveles séricos de PCRus y de Fibrinógeno. 5. Cuantificar el impacto que tiene el perfil del paciente, determinado por las variables de confusión, en los niveles séricos de PCRus y de Fibrinógeno. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion criteria: Patients with a Probing Depth > 3 mm in at least oneprobing site in two or more teeth |
Criterios de inclusión: pacientes con una profundidad de sondaje > 3 mm en al menos un sitio de sondeo en dos o más dientes |
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E.4 | Principal exclusion criteria |
Exclusion criteria: Patients who have total edentulism, have received periodontal treatment in the last year, there being a decrease in inflammatory activity, are pregnant or breastfeeding, given the immunological tolerance during pregnancy, they are diagnosed of ulceronecrotizing gingivitis (NUG), being an acute process, ulceronecrotizing periodontitis (NUP), being an acute process or diagnosed with HIV, due to the state of immunosuppression, recent history of angina, myocardial infarction or CVA, since they suppose a confusion factor when elevating the serum levels of the biomarkers, antecedents of acute inflammatory processes or recent traumatisms, suffer chronic ingestion of non-steroidal anti-inflammatory drugs (NSAIDs) or glucocorticoids, decrease the immune and inflammatory response, have taken antibiotics in the last three months, since they decrease the inflammatory activity and therefore the serum levels of biomarkers. |
Criterios de exclusión: los pacientes que tienen edentulismo total, han recibido tratamiento periodontal en el último año, debido a una disminución de la actividad inflamatoria, están embarazadas o amamantando, dada la tolerancia inmunológica durante el embarazo, se les diagnostica gingivitis ulceronecrotizing (NUG), siendo una Proceso agudo, periodontitis ulceronecrotizante (NUP), proceso agudo o diagnosticado con VIH, debido al estado de inmunosupresión, antecedentes recientes de angina, infarto de miocardio o ACV, ya que suponen un factor de confusión al elevar los niveles séricos de los biomarcadores. Antecedentes de procesos inflamatorios agudos o traumatismos recientes, sufren ingestión crónica de antiinflamatorios no esteroideos (AINE) o glucocorticoides, disminuyen la respuesta inmune e inflamatoria, han tomado antibióticos en los últimos tres meses, ya que disminuyen la actividad inflamatoria y, por tanto, Los niveles séricos de biomarcadores. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Study the relationship between periodontal disease and the level of ultrasensitive Reactive C Protein and Fibrinogen. |
Estudio sobre la relación entre la enfermedad periodontal y el nivel de Proteína C Reactiva ultrasensible y de Fibrinógeno. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
The re-evaluation will be carried out three months after the end of periodontal treatment, since the biofilm is restructured during this period of time |
La reevaluación se llevará a cabo tres meses después del final del tratamiento periodontal, ya que la biopelícula se reestructura durante este período de tiempo. |
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E.5.2 | Secondary end point(s) |
1. Establish the relationship between the different clinical variables of the periodontal study, with the value of PCRus 2. To establish the relationship between the different clinical variables of the periodontal study, with the serum level of Fibrinogen. 3. To establish the relationship between the different clinical variables of the periodontal study before and after the non-surgical periodontal treatment, and the serum levels of CRP and Fibrinogen. 4. To quantify the impact of the use of topical Doxycycline, as an adjuvant medication for periodontal treatment, on the serum levels of CRP and Fibrinogen. 5. Quantify the impact of the patient's profile, determined by the confounding variables, on the serum levels of CRP and Fibrinogen. |
1. Establecer la relación entre las distintas variables clínicas del estudio periodontal, con el valor de PCRus 2. Establecer la relación entre las distintas variables clínicas del estudio periodontal, con el nivel sérico de Fibrinógeno. 3. Establecer la relación entre las distintas variables clínicas del estudio periodontal antes y después del tratamiento periodontal no quirúrgico, y los niveles séricos de PCRus y de Fibrinógeno. 4. Cuantificar el impacto que tiene la utilización de Doxiciclina tópica, como medicación adyuvante del tratamiento periodontal, en los niveles séricos de PCRus y de Fibrinógeno. 5. Cuantificar el impacto que tiene el perfil del paciente, determinado por las variables de confusión, en los niveles séricos de PCRus y de Fibrinógeno. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
The re-evaluation will be carried out three months after the end of periodontal treatment, since the biofilm is restructured during this period of time |
La reevaluación se llevará a cabo tres meses después del final del tratamiento periodontal, ya que la biopelícula se reestructura durante este período de tiempo. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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 | No |
E.8.2.3 | Other | No |
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
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It would not be accounted for the purpose of the study |
No sería contabilizado a objeto del estudio |
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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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |