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Volumetric Efficacy of Alveolar Ridge Preservation (ARP)

4 de septiembre de 2026 actualizado por: Universidad del Desarrollo

Comparative Efficacy of Three Alveolar Ridge Preservation Techniques for Volumetric Tissue Maintenance Following Tooth Extraction

The goal of this clinical trial is to compare the effectiveness of four post-extraction socket management approaches in preserving alveolar ridge dimensions following tooth extraction in adults requiring implant-supported rehabilitation in posterior regions.

The main questions it aims to answer are:

  • Which treatment approach provides the greatest preservation of hard- and soft-tissue dimensions 12 weeks after tooth extraction?
  • Does the use of a dense polytetrafluoroethylene (d-PTFE) membrane improve alveolar ridge preservation compared with approaches that do not use a membrane?
  • Are there differences among the treatment groups regarding postoperative healing, complications, pain, and bone regeneration?

Researchers will compare spontaneous socket healing, autologous blood clot with d-PTFE membrane, autologous blood clot with leukocyte- and platelet-rich fibrin (L-PRF), and autologous blood clot with L-PRF plus d-PTFE membrane to determine which approach provides the best preservation of alveolar ridge dimensions and tissue healing.

Participants will:

  • Undergo tooth extraction and be randomly assigned to one of four treatment groups.
  • Receive clinical examinations, intraoral scans, photographs, and cone-beam computed tomography (CBCT) imaging at scheduled follow-up visits.
  • Complete assessments of postoperative pain and oral health-related quality of life.
  • Undergo implant placement 12 weeks after tooth extraction, including collection of a bone biopsy for histomorphometric analysis.
  • Attend follow-up visits to evaluate peri-implant tissue health, marginal bone stability, and implant success up to 24 months after implant loading.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

Alveolar ridge dimensional changes following tooth extraction are a well-documented biological phenomenon that may compromise future implant placement and prosthetic rehabilitation. These alterations are primarily associated with physiological bone modeling and remodeling processes, particularly affecting the buccal bone plate, which is often thin and highly susceptible to post-extraction resorption.

Alveolar ridge preservation (ARP) procedures have been developed to reduce post-extraction hard- and soft-tissue volume loss. Numerous techniques have been described, including the use of barrier membranes, platelet concentrates, and grafting materials. However, substantial controversy remains regarding the necessity of membrane utilization, the role of leukocyte- and platelet-rich fibrin (L-PRF), and the optimal approach for maintaining alveolar ridge dimensions while minimizing treatment complexity and costs.

Dense polytetrafluoroethylene (d-PTFE) membranes have been proposed as an effective barrier for preserving extraction socket architecture, whereas L-PRF has been suggested to enhance soft-tissue healing and tissue regeneration through the release of autologous growth factors. Despite the widespread clinical use of both approaches, evidence comparing these treatment strategies remains limited.

This randomized controlled clinical trial aims to compare four post-extraction socket management protocols: spontaneous healing, autologous blood clot combined with a d-PTFE membrane, autologous blood clot combined with L-PRF, and autologous blood clot combined with both L-PRF and a d-PTFE membrane. The study will evaluate their effects on hard- and soft-tissue dimensional preservation, clinical healing, postoperative outcomes, histomorphometric bone formation, patient-reported quality of life, and long-term implant-related outcomes.

The findings of this study are expected to contribute to the development of evidence-based protocols for alveolar ridge preservation and to improve clinical decision-making in implant dentistry.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

70

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: Claudio M Claudio Miranda, DDS, Director
  • Número de teléfono: +56 (2) 2327 9110
  • Correo electrónico: clmirandacar@gmail.com

Copia de seguridad de contactos de estudio

  • Nombre: Dusan M Dusan Marinkovic, DDS
  • Número de teléfono: +56 (2) 2327 5256
  • Correo electrónico: dusan.marinkovic@udd.cl

Ubicaciones de estudio

  • Chile
    • Santiago Metropolitan
      • Santiago, Santiago Metropolitan, Chile, 7610315
        • Reclutamiento
        • Universidad del Desarrollo (UDD)
        • Contacto:
          • Claudio m Claudio miranda, dds
          • Número de teléfono: +56 (2) 2327 9110
          • Correo electrónico: clmirandacar@gmail.com
        • Contacto:
        • Investigador principal:
          • Claudio M Miranda, DDS
        • Sub-Investigador:
          • Francisca c Collao, DDS
        • Sub-Investigador:
          • Dusan M Marinkovic, DDS

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 aged 18 years or older.
  • Requirement for tooth extraction with the possibility of subsequent implant-supported rehabilitation in the maxillary or mandibular premolar or molar regions.
  • Extraction sockets classified as Class I to Class Va according to the modified Cardaropoli classification.
  • American Society of Anesthesiologists (ASA) Physical Status I or II.
  • Ability to understand the study procedures and provide written informed consent.

Exclusion Criteria:

  • Current treatment with bisphosphonates or systemic corticosteroids.
  • History of head and neck radiotherapy.
  • Metabolic bone disorders.
  • Teeth presenting with acute infectious pathology at the time of extraction.
  • Pregnancy or breastfeeding.
  • Inability or unwillingness to attend scheduled follow-up visits.
  • Any medical or psychological condition that, in the opinion of the investigators, could interfere with study participation or data interpretation.

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 paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Spontaneous Healing
Following atraumatic tooth extraction, the socket is left to heal spontaneously without the use of alveolar ridge preservation materials or barrier membranes.
Procedimiento: Spontaneous Healing
Following atraumatic tooth extraction, the extraction socket is left to heal naturally without the use of alveolar ridge preservation materials, grafting biomaterials, platelet concentrates, or barrier membranes. Healing occurs through spontaneous blood clot formation and physiological post-extraction tissue repair.
Otros nombres:
  • Unassisted Socket Healing
Experimental: Arm 2: Blood Clot + d-PTFE Membrane
Following atraumatic tooth extraction, the socket is allowed to fill with an autologous blood clot and is covered with a dense polytetrafluoroethylene (d-PTFE) membrane to promote alveolar ridge preservation.
Procedimiento: d-PTFE Membrane
Following atraumatic tooth extraction, the socket is allowed to fill with an autologous blood clot and is covered with a dense polytetrafluoroethylene (d-PTFE) membrane to protect the socket and support alveolar ridge preservation during healing
Experimental: Arm 3: Blood Clot + L-PRF
Following atraumatic tooth extraction, the socket is treated with autologous leukocyte- and platelet-rich fibrin (L-PRF) in combination with the natural blood clot to support tissue healing and alveolar ridge preservation.
Procedimiento: d-PTFE Membrane
Following atraumatic tooth extraction, the socket is allowed to fill with an autologous blood clot and is covered with a dense polytetrafluoroethylene (d-PTFE) membrane to protect the socket and support alveolar ridge preservation during healing
Procedimiento: Leukocyte- and Platelet-Rich Fibrin (L-PRF)
Autologous leukocyte- and platelet-rich fibrin (L-PRF) prepared from the participant's peripheral blood and placed within the extraction socket to promote tissue healing and support alveolar ridge preservation through the sustained release of growth factors.
Otros nombres:
  • Fibrina rica en plaquetas
  • L-PRF
Experimental: Blood Clot + L-PRF + d-PTFE Membrane
Following atraumatic tooth extraction, the socket is treated with autologous leukocyte- and platelet-rich fibrin (L-PRF) and covered with a dense polytetrafluoroethylene (d-PTFE) membrane to enhance tissue healing and alveolar ridge preservation.
Procedimiento: Leukocyte- and Platelet-Rich Fibrin (L-PRF)
Autologous leukocyte- and platelet-rich fibrin (L-PRF) prepared from the participant's peripheral blood and placed within the extraction socket to promote tissue healing and support alveolar ridge preservation through the sustained release of growth factors.
Otros nombres:
  • Fibrina rica en plaquetas
  • L-PRF

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Alveolar Ridge Dimensions
Periodo de tiempo: 12 weeks after tooth extraction
Change in hard- and soft-tissue dimensions of the extraction site between baseline (T1) and 12 weeks after tooth extraction (T3), assessed through three-dimensional volumetric analysis using superimposed CBCT and intraoral scan datasets. Hard-tissue measurements include horizontal ridge width at 1, 3, and 5 mm apical to the alveolar crest (HW-1, HW-3, HW-5), buccal plate width, and socket depth. Soft-tissue measurements include tissue thickness at 1, 3, and 5 mm apical to the alveolar crest (TH-1, TH-3, TH-5) and total occlusal soft-tissue height.
12 weeks after tooth extraction

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Histomorphometric Bone Formation
Periodo de tiempo: 12 weeks after tooth extraction
Percentage of newly formed bone, residual biomaterial, and connective tissue/marrow spaces measured in bone biopsy specimens obtained during implant placement.
12 weeks after tooth extraction
Postoperative Pain
Periodo de tiempo: 21 days after tooth extraction
Patient-reported postoperative pain assessed using a 100-mm Visual Analogue Scale (VAS).
21 days after tooth extraction
Postoperative Complications
Periodo de tiempo: Up to 12 weeks after tooth extraction
Frequency and severity of soft-tissue dehiscence, membrane exposure or displacement, localized infection, and uncontrolled acute pain.
Up to 12 weeks after tooth extraction
Keratinized Tissue Width
Periodo de tiempo: Baseline to 12 weeks after tooth extraction
Change in the width of keratinized tissue measured clinically in millimeters.
Baseline to 12 weeks after tooth extraction
Oral Health-Related Quality of Life
Periodo de tiempo: Baseline to 24-28 weeks after tooth extraction
Change in Oral Health Impact Profile (OHIP-14) scores between baseline and definitive implant-supported restoration.
Baseline to 24-28 weeks after tooth extraction
Bleeding on probing
Periodo de tiempo: 12 and 24 months after implant loading
Percentage of peri-implant sites presenting bleeding on probing.
12 and 24 months after implant loading
Peri-implant probing depth
Periodo de tiempo: 12 and 24 months after implant loading
Mean peri-implant probing depth measured in millimeters using a calibrated periodontal probe.
12 and 24 months after implant loading
Radiographic marginal bone level
Periodo de tiempo: 12 and 24 months after implant loading
Mean marginal bone level measured radiographically in millimeters around implants.
12 and 24 months after implant loading

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Universidad del Desarrollo

Investigadores

  • Director de estudio: Francisca c Collao, DDS, Universidad del Desarrollo
  • Investigador principal: Claudio M Miranda, dds, Universidad del Desarrollo
  • Silla de estudio: Dusan M Marinkovic, DDS, Universidad del Desarrollo

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

  • Marinkovic D, Collao F, Tello C, Miranda C, et al. (2025) Alveolar Ridge Preservation Using Clot and Dense Polytetrafluoroethylene Membrane (PTFE-d): A Novel Surgical Protocol and Clinical Case Report. Int J Oral Dent Health 11:173 doi.org/110.23937/2469-5734/1510173

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 (Estimado)

15 de septiembre de 2026

Finalización primaria (Estimado)

15 de noviembre de 2027

Finalización del estudio (Estimado)

1 de octubre de 2028

Fechas de registro del estudio

Enviado por primera vez

7 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

4 de septiembre de 2026

Publicado por primera vez (Actual)

10 de septiembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

10 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

4 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 2025-115
  • IDREF Research Grants (Otro número de subvención/financiamiento: International Congress of Oral Implantologists)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

De-identified individual participant data underlying the results reported in publications arising from this study may be made available to qualified researchers upon reasonable request to the principal investigator. Data sharing will be subject to institutional approval, ethical considerations, and applicable data protection regulations.

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. .

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