- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07673848
Autologous Platelet Concentrates on the Healing of Extraction Sockets
The Role of Autogenous Platelet Concentrates (APCs) in Post-extraction Early Wound Healing of High-risk Medication Related Osteonecrosis of the Jaw (MRONJ) Patients.
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Eligibility criteria
All of the following criteria must be fulfilled for inclusion:
- Patient must be willing to read and sign a copy of the Informed Consent Form
- Males and females ≥ 25 years old;
- Patients who are currently or previously treated with antiresorptive therapy alone or in combination with immune modulators or antiangiogenic medications for the management of cancer;
- Patients who are treated with antiresorptive therapy, bisphosphonates, for osteoporosis for more than 5 years;
- Patients who have been treated with antiresorptive therapy, bisphosphonates, for osteoporosis for less than 5 years and being concurrently treated with a systemic glucocorticoid;
- Patients who are treated with denosumab in the last nine months and being concurrently treated with a systemic glucocorticoid;
- Patients who are on the high-risk category to develop MRONJ based on the SDCEP guidance;
- Patients who require dental extractions (one per quadrant per patient) of premolar or molar teeth which are irrational to treat for any reason;
- Patients with a history of MRONJ.
The following patients will be excluded:
- Patients with MRONJ at the area of extraction;
- Patients with history of radiotherapy in the area of treatment;
- Patients with metastatic bone disease in the area of treatment;
- Self-reported pregnancy or lactation (this criterion is due to oral tissue changes related to pregnancy and nursing which can affect interpretation of study results);
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgement of the investigator, would make the subject inappropriate for entry into this trial;
- Dental extractions in people who are systemically unwell and who require hospital admission;
- Patients with poor glycaemic control (uncontrolled diabetes);
- Current smokers or smokers who have quit less than 10 years ago (including e-cigarettes)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Patients with MRONJ
A-PRF extraction sockets
|
For patients in the A-PRF group, venepuncture will be performed with a tourniquet, a butterfly needle (such as a 21-gauge Vacutainer Safety-Lok), and A-PRF blood bottles. Two 10 mL vials of blood will be obtained. The vials will be centrifuged at 1300 rpm using the Choukroun Duo Quattro PRF Centrifuge for 14 min. For patients on anticoagulant medication, the vials will undergo further centrifugation for 2 minutes. The A-PRF clots are then removed from the tube and separated from the red blood cells and platelet-poor plasma. They are then placed in an expression kit for 10 min (which will be monitored using a timer) to drain and compress. Once the membranes have been compressed for at least 10 minutes, they will be placed in the extraction socket and secured with 4-0 PTFE sutures. |
|
Sin intervención: Control
Unassisted extraction sockets
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Proteomic biomarker expression changes in wound exudate (NSAF-based analysis)
Periodo de tiempo: At 1, 3, 7 and 15 days post-extraction
|
Wound exudate from the three groups will be analysed to assess for changes in protein expression and signalling pathways during early wound healing. A small sterile medical grade PVA sponge will be used to collect the wound exudate from the extraction socket (such as NETCELL® PVA Microspheres, Network Medical Products Ltd, North Yorkshire, UK). Analytes involved in the healing process such as angiogenesis, wound healing, inflammation, bone remodelling, and formation will be selected based on the pathways identified in the genomic and proteomic work and literature search performed by our group. Multiplex (Luminex, R&D systems, Minneapolis, MN, USA) immunoassays will be designed specifically for quantitative analyses in the wound exudate of the socket. The molecular (proteomic) changes of wound exudate of the dental extraction socket will be assessed at 1, 3, 7, 15 days after extraction based on the Normalised Spectral Abundance Factor (NSAF) proteomic analysis. |
At 1, 3, 7 and 15 days post-extraction
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- IRAS: 368825
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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