E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
• Patients who require extraction of dental elements and subsequent implant rehabilitation in the same site. |
Pazienti che necessitano di estrazione di elementi dentali e successiva riabilitazione implantare nel medesimo sito
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E.1.1.1 | Medical condition in easily understood language |
• Patients who require extraction of dental elements and subsequent implant rehabilitation in the same site. |
Pazienti che necessitano di estrazione di elementi dentali e successiva riabilitazione implantare nel medesimo sito
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E.1.1.2 | Therapeutic area | Body processes [G] - Bones and nerves physological processes [G11] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10068975 |
E.1.2 | Term | Bone atrophy |
E.1.2 | System Organ Class | 10028395 - Musculoskeletal and connective tissue disorders |
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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 |
The evaluation of the healing of post-extraction site following administration of PRP obtained from umbilical cord with modulation of specific cytokines |
• Valutazione della guarigione del sito post-estrattivo in seguito a somministrazione di PRP ottenuto da cordone ombelicale con modulazione di citochine specifiche |
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E.2.2 | Secondary objectives of the trial |
Analysis of the cell population involved in the healing process Assessment of bone resorption around dental implants
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• Analisi della popolazione cellulare coinvolta nei processi di guarigione • Valutazione del riassorbimento osseo attorno a impianti dentali
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Patients who require extraction of dental elements and subsequent implant rehabilitation in the same site. • Men and Women • Patients aged between 18 and 75 years old at the time of the surgery • Patients that had signed the Informed Consensus
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• • Pazienti che necessitano di estrazione di elementi dentali e successiva riabilitazione • implantare nel medesimo sito • • Uomini o Donne • • Pazienti di età compresa tra i 18 e i 75 anni al momento dell'intervento • • Pazienti che hanno firmato il Consenso Informato
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E.4 | Principal exclusion criteria |
Patients with serious clinical situation that, at the researcher’s opinion , advise against the participation at this study. • Patients that take or took medicines that can affect osseous metabolism, and the tissue regeneration and reparation. • Patients that take other sperimental medicines • Patients with uncontrolled diabetes mellitus or serious methabolic diseases • Pregnancy • Patients with neoplastic diseases
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•Pazienti con gravi condizioni cliniche che, a giudizio dello sperimentatore, controindicano la partecipazione del paziente allo studio •Pazienti che assumono o hanno assunto farmaci della famiglia dei bisfosfonati •Utilizzo di farmaci sperimentali •Pazienti con diabete mellito non controllato o con gravi malattie metaboliche •Donne in gravidanza •Pazienti con neoplasie in atto
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E.5 End points |
E.5.1 | Primary end point(s) |
The evaluation of the healing of post-extraction site following administration of PRP obtained from umbilical cord with modulation of specific cytokines |
• Valutazione della guarigione del sito post-estrattivo in seguito a somministrazione di PRP ottenuto da cordone ombelicale con modulazione di citochine specifiche |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Analysis of the cell population involved in the healing process Assessment of bone resorption around dental implants
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• Analisi della popolazione cellulare coinvolta nei processi di guarigione • Valutazione del riassorbimento osseo attorno a impianti dentali
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
2 months for Analysis of the cell population involved in the healing process 16 months for Assessment of bone resorption around dental implants |
2 mesi per Analisi della popolazione cellulare coinvolta nei processi di guarigione 16 mesi per Valutazione del riassorbimento osseo attorno a impianti dentali
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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 | No |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
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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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 | 24 |
E.8.9.1 | In the Member State concerned days | |