Prevention of Mandibular Third Molar Extraction- Associated Periodontal Defects Using Platelet-Rich Fibrin
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Eighteen young patients with bilateral impacted mandibular third molars will be selected. All 36 cases of impactions will be selected for a split mouth study and randomly treated by using 2 different therapeutic approaches, thereby yielding 2 different study groups, each of which is composed of 18 cases: in one side the post-extraction socket is left healing spontaneously, on the other side the socket is filled with PRF.
CAL at the distal surface of the lower second molar is chosen as primary outcome.
Criteria will be the presence of a pocket distal to the mandibular second molar with a probing depth >7 mm and a probing clinical attachment level >6mm.
This study was designed as a single-blind research since subjects will be unaware of their treatment allocation. A software will be used to produce a random sequence of 18 integer numbers without duplicates generated from atmospheric noise and concealed in closed envelopes by one of the investigators. At the time of the patient's first surgery, the envelope will be opened and patient allocated either to group 1 (PRF on the right side, spontaneous healing on the left side), for allocation numbers 1-9, or group 2 (spontaneous healing on the right side, PRF on the left side), for allocation numbers 10-18.
One clinician, not involved in patient treatment and not aware of what therapeutic approach used for the different sites of treatment, will perform all clinical measurements (PD, CAL, gingival recession, plaque index and gingival bleeding index) before and after 12 and 18 weeks of surgery.
Clinical and radiographical measurements will be recorded at 12 and 18 weeks after the surgery. The Student t test will be used to compare the differences between the 2 groups.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Naples, Italia, 80131
- Gilberto Sammartino
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion criteria Patients of both genders and any race, between 18 and 35 year-old
- Periodontally health patients and treated periodontally compromised patients
- Enrollment on a regular supportive periodontal therapy (SPT) program.
- Full-mouth plaque score (FMPS)< 25% at baseline;
- Full-mouth bleeding score (FMBS)< 25% at baseline;
- Patients having bilateral mesioangular impacted mandibular third molars with the presence of a pocket distally to the mandibular second molar with a probing depth (PD) ≥7 mm
- Intact buccal and lingual cortical bone of the post-extraction site
Exclusion Criteria:
- General contra-indications for surgery (systemic disease, compromised immune system etc);
- Tobacco smoking
- Pregnancy and lactation
- Untreated periodontal conditions;
- Acute infection in the site of the extraction
- Patients taking any medications which might interfere with coagulation
- Platelet count < 150000/mm3
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: PRF (platelet-rich fibrin)
PRF will be used after the extraction of the third molar to prevent periodontal defects to second molar
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After loco-regional anesthesia was administered, a full-thickness mucoperiosteal flap was raised.
The flap incision was extended from the vestibular side of the retromolar trigon to the second molar, corresponding to its distolingual cusp.
The incision continued intrasulcular at the second molar and proceeded with a release incision distally to the papilla between the first and second molars, on a 45° angle.
An osteotomy using a Lindemann burr under constant irrigation, followed by an odontotomy using a diamond burr was performed, if necessary
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Comparador activo: spontaneous healing
after the extraction of the third molar the socket will be left to heal spontaneously
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After loco-regional anesthesia was administered, a full-thickness mucoperiosteal flap was raised.
The flap incision was extended from the vestibular side of the retromolar trigon to the second molar, corresponding to its distolingual cusp.
The incision continued intrasulcular at the second molar and proceeded with a release incision distally to the papilla between the first and second molars, on a 45° angle.
An osteotomy using a Lindemann burr under constant irrigation, followed by an odontotomy using a diamond burr was performed, if necessary
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Clinical attachment level change
Periodo de tiempo: 12 and 18 weeks
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the clinical attachment level is the distance between the gingival margin to the cemento-enamel junction. the measurement is made by using a Williams periodontal probe. Differences in changes are measured from baseline to 12 and 18 weeks. |
12 and 18 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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probing depth change
Periodo de tiempo: 12 and 18 weeks
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The probing depth is the distance from the free end of the gingival margin to the bottom of the periodontal pocket.
The measurement is made by using a Williams periodontal probe.
Differences in changes are measured from baseline to 12 and 18 weeks.
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12 and 18 weeks
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gingival recession change
Periodo de tiempo: 12 and 18 weeks
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The distance between the cemento-enamel junction and gingival margin gives the level of recession. The measurement is made by using a Williams periodontal probe. Differences in changes are measured from baseline to 12 and 18 weeks. |
12 and 18 weeks
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Gilberto Sammartino, Professor, Federico II University
Publicaciones y enlaces útiles
Publicaciones Generales
- Cabaro S, D'Esposito V, Gasparro R, Borriello F, Granata F, Mosca G, Passaretti F, Sammartino JC, Beguinot F, Sammartino G, Formisano P, Riccitiello F. White cell and platelet content affects the release of bioactive factors in different blood-derived scaffolds. Platelets. 2018 Jul;29(5):463-467. doi: 10.1080/09537104.2017.1319046. Epub 2017 Jun 21.
- Sammartino G, Dohan Ehrenfest DM, Carile F, Tia M, Bucci P. Prevention of hemorrhagic complications after dental extractions into open heart surgery patients under anticoagulant therapy: the use of leukocyte- and platelet-rich fibrin. J Oral Implantol. 2011 Dec;37(6):681-90. doi: 10.1563/AAID-JOI-D-11-00001. Epub 2011 Jun 30.
- Sammartino G, Tia M, Marenzi G, di Lauro AE, D'Agostino E, Claudio PP. Use of autologous platelet-rich plasma (PRP) in periodontal defect treatment after extraction of impacted mandibular third molars. J Oral Maxillofac Surg. 2005 Jun;63(6):766-70. doi: 10.1016/j.joms.2005.02.010.
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
- 56/15
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.
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. .
Ensayos clínicos sobre Molar, Tercero
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Postgraduate Institute of Dental Sciences RohtakTerminadoDiente del tercer molar impactado | Cirugía de extracción del tercer molar | Extracción del tercer molar | Molar del Juicio ImpactadoIndia
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Huashan HospitalAún no reclutandoMolar, Tercero | Fotobiomodulación | Cirugía del tercer molar | Terapia de FotobiomodulaciónPorcelana
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Bahçeşehir UniversityTerminadoCirugía de extracción del tercer molar | Impactación del tercer molar | Encuesta de satisfacciónTurquía (Türkiye)
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Fayoum UniversityActivo, no reclutandoTercer molarEgipto
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TriAgenics IncRetirado
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Universitat Internacional de CatalunyaReclutamientoPulpotomía molar primariaEspaña
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Recep Tayyip Erdogan UniversityTerminadoMolar del Juicio ImpactadoTurquía (Türkiye)
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Centre Hospitalier Universitaire de NīmesTerminadoExtracción del tercer molarFrancia
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Suez Canal UniversityActivo, no reclutando
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Eli Lilly and CompanyReclutamientoDolor agudo | Molar, Tercero | Cirugía Oral | MolarEstados Unidos
Ensayos clínicos sobre extraction of mandibular third molar
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Melaka Manipal Medical CollegeTerminadoExtracción dentalMalasia
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Lithuanian University of Health SciencesUniversity of TriesteDesconocidoDiente del tercer molar impactado | Números de estado de extracción de dientesItalia, Lituania
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Dow University of Health SciencesAún no reclutandoDolor Postoperatorio
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Marmara UniversityTerminadoDiente del tercer molar impactado | Diente impactadoPavo
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Selcuk UniversityTerminadoDiente del tercer molar impactadoPavo
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University of Sao PauloDesconocidoExtracción dental | Anestésicos localesBrasil
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CSI College of Dental Sciences and Research, MaduraiReclutamiento
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University of NaplesActivo, no reclutandoComplicaciones Postoperatorias | Molar, TerceroItalia
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Watim Medical & Dental CollegeReclutamientoDolor (visceral, somático o neuropático)Pakistán
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Sinem Büşra Kıraç CanTerminadoUmbral del dolor | Dolor Postoperatorio AgudoPavo