Comparison of Autologous Tooth and Bovine Xenograft in Periodontal Healing After Mandibular Third Molar Extraction
11 de septiembre de 2026 actualizado por: Miguel Ruiz Rincón, Universidad Complutense de Madrid
Evaluation of Changes in Probing Depth Following Surgical Extraction of Mandibular Third Molars Using Particulated Autologous Tooth vs. Particulated Bovine Xenograft vs. Blood Clot: A Randomized Clinical Trial
This study investigates the healing of periodontal defects on the distal surface of the second lower molars after the surgical extraction of impacted third molars.
Specifically, it compares the effectiveness of autologous tooth graft particles (derived from the extracted third molar) with bovine xenograft particles, using blood clot healing as a control.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Descripción detallada
This study investigates the healing of periodontal defects on the distal surface of the second lower molars after the surgical extraction of impacted third molars. Specifically, it compares the effectiveness of autologous tooth graft particles (derived from the extracted third molar) with bovine xenograft particles, using blood clot healing as a control.
Lower third molars are the most frequently impacted teeth, and their extraction can sometimes lead to or worsen periodontal defects on the adjacent second molar. Previous studies have shown positive outcomes using various bone regeneration materials; however, autologous tooth grafts have recently emerged as a biocompatible, osteoconductive, and osteoinductive alternative with promising results. Despite this, there are no clinical studies directly comparing autologous tooth grafts and bovine xenografts in this context-justifying the present research.
A prospective, randomized split-mouth clinical trial with three arms will be conducted at the Complutense University of Madrid. Each patient will undergo bilateral lower third molar extractions under three conditions:
Group A (Test 1): socket filled with autologous tooth graft,
Group B (Test 2): socket filled with bovine xenograft,
Group C (Control): socket left to heal naturally with a blood clot.
The main objective is to evaluate the reduction in probing depth on the distal surface of the second molar six months post-extraction.
Secondary outcomes include postoperative pain, inflammation, trismus, complications, wound healing, and patient-reported outcomes (PoSSe questionnaire).
Approximately 30 patients will be included, with triple randomization (side of first extraction, use of graft, and graft type). Clinical and radiographic evaluations will be performed preoperatively, and follow-ups will occur at 48 hours, one week, three months, and six months.
The null hypothesis (H₀) states that there will be no periodontal differences between the two graft materials, while the alternative hypothesis (H₁) proposes superior periodontal outcomes with the autologous tooth graft compared to the bovine xenograft.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
30
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Miguel Ruiz Rincón, DDS
- Número de teléfono: +34 680276072
- Correo electrónico: migrui02@ucm.es
Ubicaciones de estudio
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Madrid
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Madrid, Madrid, España, 28040
- Reclutamiento
- Postgrado de especialización en cirugía bucal e implantología, Facultad de Odontología, Universidad Complutense de Madrid
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Contacto:
- Miguel Ruiz Rincón, DDS
- Número de teléfono: +34 680 27 60 72
- Correo electrónico: migrui02@ucm.es
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Descripción
Inclusion Criteria:
- Adults (≥18 years old) of any sex, able to understand and follow study instructions.
- Patients requiring bilateral surgical extraction of impacted lower third molars in horizontal or mesioangular position.
- Presence of both lower second molars.
- Classified as ASA I or ASA II (according to the American Society of Anesthesiologists).
- Willingness to participate voluntarily and sign informed consent.
Exclusion Criteria:
- Age under 18 years.
- ASA physical status III, IV, V, or VI.
- Pregnant or breastfeeding women.
- Immunosuppressed patients.
- Current treatment with NSAIDs, anticoagulants, or acetylsalicylic acid.
- Previous or current treatment with bisphosphonates.
- Presence of oral dysplasia or precancerous lesions.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Autologous Tooth Graft (Test 1)
After surgical extraction of the impacted lower third molar, the socket will be filled with autologous tooth graft particles obtained from the extracted tooth using the Smart Dentin Grinder®.
The graft particles (300-1200 µm) will be decontaminated, rinsed, and placed on the distal surface of the second molar.
The graft will be covered with a resorbable hemostatic sponge (Roeko Gelatamp®) before suturing.
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Autologous tooth graft particles are prepared from the extracted third molar using the Smart Dentin Grinder®.
The tooth is cleaned, dried, and ground to particles of 300-1200 µm, decontaminated with 0.5 M sodium hydroxide and 20% ethanol, rinsed with sterile saline, and placed on the distal surface of the second molar.
The graft is covered with a resorbable hemostatic sponge (Roeko Gelatamp®) prior to wound closure.
Otros nombres:
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|
Comparador activo: Bovine Xenograft (Test 2)
After extraction of the impacted lower third molar, the socket will be filled with particulate bovine xenograft (InterOss®) hydrated in sterile saline.
The material will be placed on the distal surface of the second molar and covered with a resorbable hemostatic sponge before suturing.
|
Autologous tooth graft particles are prepared from the extracted third molar using the Smart Dentin Grinder®.
The tooth is cleaned, dried, and ground to particles of 300-1200 µm, decontaminated with 0.5 M sodium hydroxide and 20% ethanol, rinsed with sterile saline, and placed on the distal surface of the second molar.
The graft is covered with a resorbable hemostatic sponge (Roeko Gelatamp®) prior to wound closure.
Otros nombres:
|
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Sin intervención: Blood Clot (Control)
Following extraction of the impacted lower third molar, the socket will be left to heal naturally through blood clot formation, without placement of any graft material or hemostatic sponge.
Standard wound closure and postoperative care will be provided.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Reduction in probing depth on the distal surface of the mandibular second molar
Periodo de tiempo: Baseline (preoperative), 3 months, and 6 months post-extraction
|
Periodontal probing depth (in millimeters) measured on the distal surface of the lower second molar using a calibrated periodontal probe (CP12).
The reduction in probing depth will be compared among the three groups (autologous tooth graft, bovine xenograft, and blood clot control) to evaluate periodontal healing following extraction of the lower third molars.
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Baseline (preoperative), 3 months, and 6 months post-extraction
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Postoperative swelling
Periodo de tiempo: Preoperative, 48 hours, and 7 days post-extraction
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Facial swelling measured as the linear distance between anatomical landmarks (tragus-commissure, tragus-gonion, and gonion-commissure) using a suture thread and caliper.
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Preoperative, 48 hours, and 7 days post-extraction
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Postoperative trismus
Periodo de tiempo: Preoperative, 48 hours, and 7 days post-extraction
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Maximum interincisal mouth opening measured in millimeters using a caliper.
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Preoperative, 48 hours, and 7 days post-extraction
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Wound healing quality
Periodo de tiempo: 48 hours, and 7 days post-extraction
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linical evaluation of the surgical site according to Blum's criteria (good, acceptable, poor), based on mucosal color, bleeding, wound margins, and closure.
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48 hours, and 7 days post-extraction
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Patient-reported quality of life
Periodo de tiempo: 7 days post-extraction
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Assessed using the Postoperative Symptom Severity (PoSSe) scale, covering pain, function, daily activities, and social interaction after surgery.
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7 days post-extraction
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Surgical time
Periodo de tiempo: Intraoperatively
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Minutes and seconds recorded intraoperatively
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Intraoperatively
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Surgical difficulty
Periodo de tiempo: Intraoperatively
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Classified according to the modified Parant scale: Types I-IV
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Intraoperatively
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Director de estudio: José María Martínez-González, MD,DMD,PhD,MDV, Department of Dental Clinical Specialties, Faculty of Dentistry, Complutense University of Madrid
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de septiembre de 2025
Finalización primaria (Estimado)
30 de septiembre de 2026
Finalización del estudio (Estimado)
30 de septiembre de 2026
Fechas de registro del estudio
Enviado por primera vez
11 de septiembre de 2026
Primero enviado que cumplió con los criterios de control de calidad
11 de septiembre de 2026
Publicado por primera vez (Actual)
17 de septiembre de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
17 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
11 de septiembre de 2026
Última verificación
1 de octubre de 2025
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- 25/636-EC_X
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
Individual participant data (IPD) from this study will be shared with qualified researchers after the publication of primary results.
Shared data will include anonymized measurements of periodontal probing depth, postoperative outcomes (pain, swelling, trismus), PoSSe questionnaire responses, and relevant demographic and clinical variables.
Data will be de-identified to protect participant confidentiality.
Marco de tiempo para compartir IPD
IPD will be available beginning 6 months after publication of the primary study results and will remain accessible for 5 years.
Criterios de acceso compartido de IPD
Data will be available to researchers who submit a written request describing the purpose of the analysis and who agree to a data use agreement ensuring confidentiality and appropriate use.
Requests will be reviewed by the Principal Investigator or designated study committee.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- CÓDIGO_ANALÍTICO
- RSC
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
No
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. .