Experimental, prospective, randomised, controlled, double-blind, split mouth clinical trial of autologous dental pulp pluripotent cells in regeneration of mandibular defects (Q3210744): Difference between revisions
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(Created claim: summary (P836): Design: Experimental, prospective, randomised, controlled, split-mouth double-blind clinical trial on the regenerating effect of autologous dental pulp (CPPDA) pluripotent cells on mandibular defects versus its own CPPDA-free control. It’s an unexpanded, unmanned cell procedure. Compliance with legislation clinical trials. Zero hypothesis: The CPPDA collagen sponge preparation behaves the same in the experimental alveoli and control with a maxim...) |
(Changed label, description and/or aliases in en: translated_label) |
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Experimental, prospective, randomised, controlled, double-blind, split mouth clinical trial of autologous dental pulp pluripotent cells in regeneration of mandibular defects | |||
Revision as of 08:35, 14 October 2021
Project Q3210744 in Spain
| Language | Label | Description | Also known as |
|---|---|---|---|
| English | Experimental, prospective, randomised, controlled, double-blind, split mouth clinical trial of autologous dental pulp pluripotent cells in regeneration of mandibular defects |
Project Q3210744 in Spain |
Statements
11,225.0 Euro
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22,450.0 Euro
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50.0 percent
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1 January 2014
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30 September 2018
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ASOCIACION INSTITUTO DE INVESTIGACION SANITARIA BIOCRUCES
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43°17'43.73"N, 2°59'24.32"W
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48013
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Diseño: Ensayo clínico experimental, prospectivo, aleatorizado, controlado, doble ciego de boca partida, sobre el efecto regenerador de células pluripotenciales de la pulpa dental autóloga (CPPDA) en defectos mandibulares frente a su propio control sin CPPDA. Es un procedimiento de células no expandidas, no manipuladas. Cumplimiento de legislación ensayos clinicos. Hipótesis nula: El preparado CPPDA en esponja de colágeno se comporta igual en el alveolo experimental y control con una diferencia máxima de proporciones de 0.4 H0= P2-P1=0.4. Hipótesis alternativa: en el alveolo experimental el preparado CPPDA en esponja de colágeno responde con mayor volumen regenerado (mm3) y mayor densidad (u Hounsfield) con una diferencia de proporciones >0.4. H1=P2-P1>0.4. Tamaño muestral: 30+4 pacientes. Ámbito: Hospital Universitario de Cruces (Barakaldo). Sujetos sanos 18-30 años con indicación de exodoncia de 2 cordales inferiores incluidos. Criterios de inclusión/exclusión. Instrumentación: Tras exodoncia de los terceros molares inferiores, se extraen sus pulpas dentarias, se disocian mecánicamente y la suspensión de CPPDA obtenida se introduce en el alveolo experimental del maxilar inferior en transporte de colágeno. En el alveolo contralateral de control, colageno sin CPPDA. Variable resultado: Diferencia de regeneración media en volumen (mm3) y densidad (unidades Hounsfiel) mediante TC Cone-been entre el 7º día de las exodoncias y los seis meses. Control variables clínicas: Sondaje periodontal en alveolos midiendo profundidad, nivel de inserción. Estudio estadístico: descriptivo y analítico. Programa: SPSS PC 18. (Spanish)
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Design: Experimental, prospective, randomised, controlled, split-mouth double-blind clinical trial on the regenerating effect of autologous dental pulp (CPPDA) pluripotent cells on mandibular defects versus its own CPPDA-free control. It’s an unexpanded, unmanned cell procedure. Compliance with legislation clinical trials. Zero hypothesis: The CPPDA collagen sponge preparation behaves the same in the experimental alveoli and control with a maximum difference of ratios of 0.4 H0= P2-P1=0.4. Alternative scenario: in the experimental alveoli the CPPDA preparation in collagen sponge responds with higher regenerated volume (mm³) and higher density (u Hounsfield) with a difference of proportions >0.4. H1=P2-P1>0.4. Sample size: 30+ 4 patients. Scope: University Hospital of Cruces (Barakaldo). Healthy subjects 18-30 years with indication of exodus of 2 lower cords included. Inclusion/exclusion criteria. Instrumentation: After exodance of the lower third molars, their tooth pulps are extracted, mechanically dissociated and the CPPDA suspension obtained is introduced into the experimental alveoli of the lower maxillary in collagen transport. In the contralateral control alveolo, colagene without CPPDA. Variable result: Difference of mean regeneration in volume (mm³) and density (Hounsfiel units) using CT Cone-been between the 7th day of the exodences and six months. Control of clinical variables: Periodontal probe in alveolos measuring depth, insertion level. Statistical study: descriptive and analytical. Programme: SPSS PC 18. (English)
14 October 2021
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Barakaldo
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Identifiers
PI13_00541
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