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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07604584
Effects of Platelet-Rich Fibrin After Mandibular Third Molar Surgery in Smokers and Nonsmokers
Effects of Platelet-Rich Fibrin on Postoperative Pain, Trismus and Swelling After Impacted Mandibular Third Molar Surgery in Smokers and Nonsmokers: A Prospective Clinical Study
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
This prospective randomized split-mouth clinical trial was conducted between 2017 and 2019 at the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Ankara University. The study aimed to evaluate the effects of platelet-rich fibrin (PRF) on postoperative pain, swelling, trismus, and analgesic consumption after impacted mandibular third molar surgery in smoking and nonsmoking patients.
A total of 30 systemically healthy patients aged 18-35 years with bilaterally impacted mandibular third molars were included. Patients were divided into smoking and nonsmoking groups. In each patient, PRF was randomly applied to one extraction socket, while the contralateral socket served as the control site without PRF application. All surgical procedures were performed by the same oral and maxillofacial surgeon using a standardized surgical protocol. Outcome assessments were performed by a different clinician blinded to the intervention side.
Postoperative pain was evaluated using a visual analog scale (VAS). Facial swelling was assessed using linear facial measurements between anatomical landmarks, and trismus was evaluated by measuring maximum interincisal distance. Clinical evaluations were performed preoperatively and on postoperative days 1, 2, 3, and 7.
The primary outcome of the study was postoperative pain intensity. Secondary outcomes included postoperative swelling, trismus, and analgesic consumption. The study also aimed to compare the clinical effectiveness of PRF between smokers and nonsmokers.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Ankara, Turquía (Türkiye), 06560
- Ankara University Faculty of Dentistry
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Systemically healthy patients aged between 18 and 35 years
- Bilaterally impacted mandibular third molars
- Mandibular third molars classified as Pell and Gregory Class I, Position C
- Mandibular third molars classified as Parant Class II difficulty
- Smoking and nonsmoking patients
- Patients willing to participate and provide written informed consent
Exclusion Criteria:
- Presence of acute infection or pericoronitis
- Pregnancy or lactation
- Alcohol or substance abuse
- Use of oral contraceptives
- Menstrual period during surgery
- Antibiotic use within the previous month
- Smoking more than 10 cigarettes per day
- Agitation or inability to cooperate
- Incomplete follow-up data
- Systemic disease contraindicating oral surgery
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: PRF-treated socket
Platelet-rich fibrin (PRF) was placed into the extraction socket following impacted mandibular third molar surgery.
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Autologous platelet-rich fibrin prepared from venous blood by centrifugation and placed into the extraction socket after mandibular third molar extraction.
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Sin intervención: Control socket
The contralateral extraction socket was primarily closed without PRF application after mandibular third molar surgery.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Postoperative Pain Intensity
Periodo de tiempo: Postoperative days 1, 2, 3, and 7
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Postoperative pain intensity assessed using a 100-mm visual analog scale (VAS) after impacted mandibular third molar surgery.
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Postoperative days 1, 2, 3, and 7
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Postoperative Facial Swelling
Periodo de tiempo: Preoperative period and postoperative days 1, 2, 3, and 7
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Postoperative facial swelling assessed using linear facial measurements between anatomical landmarks.
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Preoperative period and postoperative days 1, 2, 3, and 7
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Postoperative Trismus
Periodo de tiempo: Preoperative period and postoperative days 1, 2, 3, and 7
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Trismus assessed by measuring maximum interincisal mouth opening distance.
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Preoperative period and postoperative days 1, 2, 3, and 7
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Postoperative Analgesic Consumption
Periodo de tiempo: Postoperative days 1, 2, 3, and 7
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Number of analgesic tablets used during the postoperative follow-up period.
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Postoperative days 1, 2, 3, and 7
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Mehmet Emre Yurttutan, PhD, DDS, Ankara University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 36290600/51
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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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