Effect of Platelet-Rich Fibrin on Postoperative Pain, Trismus, and Edema After Mandibular Third Molar Surgery (PRF-M3M)
Evaluation of the Effects of Platelet-Rich Fibrin on Postoperative Pain, Trismus, and Edema Following Surgical Removal of Mandibular Third Molars
Impacted mandibular third molars are among the most commonly encountered conditions in oral and maxillofacial surgery. Surgical removal of these teeth is frequently associated with postoperative complications such as pain, facial swelling, and trismus, which may affect patients' daily activities and quality of life.
Platelet-rich fibrin (PRF) is an autologous platelet concentrate prepared from the patient's own blood and contains various growth factors that may promote wound healing and reduce postoperative inflammation. The present randomized controlled trial aims to evaluate the effectiveness of PRF in reducing postoperative pain, trismus, and facial swelling after surgical removal of mandibular third molars.
Participants with impacted mandibular third molars meeting the eligibility criteria will be randomly allocated into two groups. The intervention group will receive PRF placement in the extraction socket, while the control group will receive sterile absorbable gelatin sponge (Gelfoam) after tooth removal. Postoperative pain, mouth opening, and facial swelling will be assessed preoperatively and on the first and seventh postoperative days.
The findings of this study may help determine whether PRF improves postoperative recovery following mandibular third molar surgery.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Impacted mandibular third molars frequently require surgical removal and represent one of the most commonly performed procedures in oral and maxillofacial surgery. Postoperative complications such as pain, facial swelling, and trismus commonly occur following surgical extraction and may negatively affect oral function and quality of life.
Various approaches have been proposed to reduce postoperative morbidity, including nonsteroidal anti-inflammatory drugs, corticosteroids, cold therapy, hyaluronic acid, and other adjunctive methods. Platelet-rich fibrin (PRF) is a second-generation autologous platelet concentrate that contains a fibrin matrix enriched with platelets, leukocytes, cytokines, and growth factors. These biological mediators contribute to angiogenesis, tissue regeneration, collagen synthesis, and wound healing.
The purpose of this randomized controlled trial is to evaluate the effects of platelet-rich fibrin on postoperative pain, trismus, and facial swelling following surgical removal of mandibular third molars.
Eligible participants aged 18 to 50 years with impacted mandibular third molars fulfilling the inclusion criteria will be recruited from the Department of Oral and Maxillofacial Surgery, Pakistan Atomic Energy Commission General Hospital, Islamabad. After obtaining written informed consent, participants will be randomly assigned to one of two groups:
PRF group: Platelet-rich fibrin will be prepared from the patient's venous blood and placed into the extraction socket before wound closure.
Control group: Sterile absorbable gelatin sponge (Gelfoam) will be placed into the extraction socket before wound closure.
Standardized surgical procedures, local anesthesia, medications, and postoperative instructions will be provided to all participants.
Outcome measures will include:
Postoperative pain assessed using the Visual Analog Scale (VAS). Trismus assessed by maximum interincisal opening measured in millimeters. Facial swelling assessed using standardized facial measurements. Measurements will be recorded preoperatively and on postoperative days 1 and 7.
The primary outcomes are postoperative pain and trismus, while facial swelling is considered a secondary outcome. Statistical analysis will compare outcomes between the two groups to determine whether PRF improves postoperative recovery after mandibular third molar surgery.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Federal
-
Islamabad, Federal, Pakistán, 44100
- PAEC General Hospital, Islamabad
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
Patients aged 18 to 50 years Patients with impacted mandibular third molars indicated for surgical extraction Mesioangular or vertical impactions (Winter classification) Class II or Class III impactions, Position B or C (Pell and Gregory classification) Patients who provide written informed consent
Exclusion Criteria:
Pregnant or lactating females Patients with systemic diseases affecting healing (e.g., uncontrolled diabetes, immunocompromised states) Smokers Patients on medications affecting bone or soft tissue healing Patients with acute infection at the surgical site
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Platelet-Rich Fibrin (PRF) Group
Participants undergoing surgical removal of impacted mandibular third molars will receive platelet-rich fibrin (PRF) prepared from autologous venous blood and placed into the extraction socket before wound closure.
Standard postoperative medications and instructions will be provided.
|
Platelet-rich fibrin (PRF) will be prepared from 10 mL of autologous venous blood collected from the participant.
The blood sample will be centrifuged at 2700 rpm for 12 minutes to obtain the fibrin clot.
Following surgical extraction of the mandibular third molar, the PRF clot will be placed into the extraction socket before wound closure.
|
|
Comparador activo: Gelfoam Control Group
Participants undergoing surgical removal of impacted mandibular third molars will receive sterile absorbable gelatin sponge (Gelfoam) placed into the extraction socket before wound closure.
Standard postoperative medications and instructions will be provided.
|
Following surgical extraction of the mandibular third molar, a sterile absorbable gelatin sponge (Gelfoam) will be placed into the extraction socket before wound closure.
Standard postoperative medications and instructions will be provided to all participants.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Postoperative Pain
Periodo de tiempo: Preoperative baseline, postoperative day 1, and postoperative day 7
|
Postoperative pain will be assessed using a 10-cm Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain.
Pain scores will be recorded and compared between the platelet-rich fibrin and Gelfoam groups.
|
Preoperative baseline, postoperative day 1, and postoperative day 7
|
|
Postoperative Trismus
Periodo de tiempo: Preoperative baseline, postoperative day 1, and postoperative day 7
|
Trismus will be assessed by measuring the maximum interincisal opening in millimeters using a vernier caliper.
The distance between the upper and lower central incisors at maximum mouth opening will be recorded and compared between the study groups.
|
Preoperative baseline, postoperative day 1, and postoperative day 7
|
|
Postoperative Facial Swelling (Edema)
Periodo de tiempo: Preoperative baseline, postoperative day 1, and postoperative day 7
|
Facial swelling will be assessed using linear facial measurements taken with a measuring tape.
Measurements will include the distance between the angle of the mandible and lateral canthus of the eye, tragus to corner of the mouth, and tragus to soft tissue pogonion.
The average of these measurements will be used to calculate facial dimension and assess postoperative edema.
Values will be compared between the platelet-rich fibrin and Gelfoam groups.
|
Preoperative baseline, postoperative day 1, and postoperative day 7
|
Colaboradores e Investigadores
Patrocinador
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
- OMFS-PRF-2026-01
- PAEC (Identificador de registro: PAEC)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan 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.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .