Clinical Evaluation of Two Post Systems for Single Crown Restoration of Anterior Teeth: A Randomized Controlled Clinical Trial
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Endodontically treated maxillary anterior teeth frequently present with significant loss of coronal tooth structure, compromising their resistance to fracture and complicating restoration. prefabricated fiber posts are widely used to retain a composite core prior to crown placement, but the degree to which a post adapts to the internal canal wall - leaving minimal or no gap between the post and the remaining gutta-percha - may influence long-term clinical performance and resistance to microleakage.
This study is a randomized controlled trial comparing a custom-adapted ultra-high-molecular-weight polyethylene (UHMWPE) fibers post (Ribbond-type), individually formed to the canal anatomy, against a prefabricated fiber post. Eligible teeth are endodontically treated maxillary anterior teeth with 1-2 missing coronal axial walls (mesial, distal, labial, and/or palatal), assessed at the cementoenamel junction, where any remaining sound walls meet a minimum height of 1.5-2 mm and a circumferential thickness of approximately 1 mm, in line with established ferrule criteria.
Participants will be randomly allocated to receive either the Ribbond post or the prefabricated fiber post, followed by a standardized composite core build-up and definitive crown restoration. Post space preparation, dentin conditioning, and cementation will follow a standardized step-by-step clinical protocol for each group.
The primary outcome is the post-gutta-percha gap distance, measured radiographically and expressed continuously in millimeters, with cases additionally classified as showing no gap versus any measurable gap. This dichotomization and its expected baseline distribution are informed by prior clinical data reporting outcomes in maxillary anterior teeth. The secondary outcome is post and restoration retention, evaluated clinically at follow-up using USPHS criteria.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Mohamed elsayed Bekhiet, Master Degree
- Número de teléfono: +201224238808
- Correo electrónico: Mohamed.Bekhet@dentistry.cu.edu.eg
Ubicaciones de estudio
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Manial
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Cairo, Manial, Egipto, 11553
- Faculty of dentistry cairo university
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Contacto:
- Mohamed elsayed Bekhiet, master degree
- Número de teléfono: +2.1224238808
- Correo electrónico: Mohamed.Bekhet@dentistry.cu.edu.eg
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Endodontically treated maxillary anterior teeth (incisors and/or canines)
- Presence of 1-2 missing coronal axial walls (mesial, distal, labial, and/or palatal), assessed at the cementoenamel junction (CEJ)
- Remaining sound tooth structure meeting minimum ferrule criteria: wall height ≥1.5-2 mm and circumferential thickness ≈1 mm
- Adequate root canal filling with no radiographic signs of periapical pathology
- Root length and canal morphology suitable for post space preparation
- Patients aged 20-40 years
- Willing and able to provide informed consent and attend follow-up visits
Exclusion Criteria:
- Teeth with 3 or more missing coronal axial walls (insufficient ferrule)
- Evidence of active periapical pathology, root fracture, or root resorption
- Insufficient remaining root length for adequate post retention
- Signs of periodontal disease affecting tooth prognosis (e.g., mobility, inadequate periodontal support)
- Systemic conditions contraindicating routine dental treatment
- Pregnancy (if radiographic follow-up is required)
- Inability to attend scheduled follow-up visits
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 |
|---|---|
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Comparador activo: Prefabricated Fiber Post with Composite Core
Participants receive a prefabricated fiber post, followed by a composite core build-up and definitive crown restoration.
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Participants receive a custom-fit UHMWPE fiber post, individually adapted to the canal at chairside, followed by a composite core build-up and definitive crown restoration.
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Experimental: Custom-Fit UHMWPE Fiber Post with Composite Core
Participants receive a custom-fit UHMWPE fiber post, individually adapted to the canal at chairside, followed by a composite core build-up and definitive crown restoration.
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Participants receive a custom-fit UHMWPE fiber post, individually adapted to the canal at chairside, followed by a composite core build-up and definitive crown restoration.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Post-Gutta-Percha Gap Distance
Periodo de tiempo: Immediately post-cementation (baseline)
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Distance between the outer surface of the cemented post and the residual root canal filling (gutta-percha), measured radiographically at the coronal, middle, and apical thirds of the post space.
Reported both as a continuous measurement (mm) and dichotomized as no gap versus any measurable gap.
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Immediately post-cementation (baseline)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Post and Restoration Retention
Periodo de tiempo: 6 months post-cementation
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Clinical retention of the post-core-crown restoration, assessed using United States Public Health Service (USPHS) criteria.
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6 months post-cementation
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Mohamed labib zamzam, PHD, Fixed Prosthodontics Faculty of Oral and dental medicine Cairo University
- Silla de estudio: omnia nabil, PHD, Fixed Prosthodontics Faculty of Oral and dental medicine Cairo University
Publicaciones y enlaces útiles
Publicaciones Generales
- Moezizadeh M, Shokripour M. Effect of fiber orientation and type of restorative material on fracture strength of the tooth. J Conserv Dent. 2011 Oct;14(4):341-5. doi: 10.4103/0972-0707.87194.
- de Morais DC, Butler S, Santos MJMC. Current Insights on Fiber Posts: A Narrative Review of Laboratory and Clinical Studies. Dent J (Basel). 2023 Oct 10;11(10):236. doi: 10.3390/dj11100236.
- Naim H, Ahmad M, Ageeli AA, Abuarab RK, Sayed ME, Dewan H, Chohan H, Alshehri AH, Wadei MHDA, Alqahtani SM, Feroz SMA, Porwal A, Alshahrani AA. Radiographic Evaluation of the Gap between Cemented Post and Remaining Gutta-Percha in Endodontically Treated Teeth Performed by Undergraduate Students: A Retrospective Cross-Sectional Study. Medicina (Kaunas). 2023 Mar 3;59(3):502. doi: 10.3390/medicina59030502.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
Otros números de identificación del estudio
- CEBD-CU-2025-07-29
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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