The Effect of Decoupling With Time Technique on the Clinical Performance of Proximal Posterior Composite Restorations (DWT)
The Effect of Decoupling With Time Technique on the Clinical Performance of Proximal Posterior Composite Restorations: An 18-Month Randomized Clinical Trial
This randomized clinical trial will evaluate whether the decoupling with time technique improves the clinical performance of Class II posterior composite restorations compared with conventional composite restoration techniques. The study will also assess postoperative hypersensitivity and the additional operative time required to perform the decoupling with time technique. Participants will receive a posterior composite restoration and will be followed for 18 months. Clinical performance will be evaluated using the Modified United States Public Health Service (USPHS) criteria, and postoperative hypersensitivity will be assessed before treatment, 1 week after restoration placement, and at 6, 12, and 18 months. The study will help determine whether the additional time required for the decoupling with time technique is associated with improved clinical outcomes.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
This randomized clinical trial will evaluate the effect of the decoupling with time technique on the clinical performance of posterior composite restorations in Class II cavities.
The study will include eligible participants requiring posterior Class II composite restorations. Participants will be randomly allocated to either the decoupling with time group or the conventional restoration group.
In the decoupling with time group, following cavity preparation, immediate dentin sealing will be performed using a universal adhesive system applied with a selective enamel-etching strategy. A conventional flowable resin composite will then be applied as an initial stress-reducing layer with a thickness of approximately 0.5-1.0 mm. A 5-minute waiting period will be allowed before completion of the composite restoration. Deep margin elevation will not be performed as part of the study protocol.
The control group will receive a conventional posterior composite restoration according to the standardized restorative protocol without the decoupling with time waiting period.
The primary outcome will be postoperative hypersensitivity, assessed using the Modified United States Public Health Service (USPHS) criteria. Hypersensitivity will be assessed pre-operatively, at 1 week after restoration placement, and at 6, 12, and 18 months after restoration placement.
The clinical performance of the restorations will be evaluated using the Modified USPHS criteria immediately after restoration placement and at 6, 12, and 18 months. The evaluated clinical parameters will include marginal integrity, fracture and retention, marginal discoloration, anatomic form, proximal contact, surface texture, radiographic evaluation, and secondary caries.
The total operative time required to complete each restoration will also be recorded in minutes using a digital stopwatch, starting from the beginning of the restorative procedure and ending upon completion of the restoration. This will allow assessment of whether the additional operative time associated with the decoupling with time technique is associated with improved clinical outcomes.
Participants will be followed for 18 months to evaluate the clinical performance of the restorations and postoperative hypersensitivity over time.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Mahetab Mahmoud Abd Elhameed, Master's candidate
- Número de teléfono: 201151895247
- Correo electrónico: mahetab.mahmoud@dentistry.cu.edu.eg
Copia de seguridad de contactos de estudio
- Nombre: Omar Shaalan, Assoc. Professor of Conservati
- Número de teléfono: 201122665661
- Correo electrónico: omar.shaalan@dentistry.cu.edu.eg
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Patients aged between 20 and 40 years.
- Patients with posterior carious Class II lesions.
- Good oral hygiene.
- Favorable occlusion.
- Absence of deleterious oral habits.
Exclusion Criteria:
- Teeth showing signs of irreversible pulpitis.
- Teeth with secondary caries.
- Teeth with old restorations.
- Endodontically treated teeth.
- Patients with a history of adverse reactions to the test material.
- Patients with poor oral hygiene.
- Patients with systemic disease.
- Patients with severe periodontal disease.
- Uncooperative patients.
- Patients unable to attend the scheduled recall 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 |
|---|---|
|
Experimental: Decoupling With Time Group
Participants assigned to this group will receive a Class II posterior composite restoration using the decoupling with time technique. Immediate dentin sealing will be performed using a universal adhesive system with a selective enamel-etching strategy, followed by application of a 0.5-1.0 mm layer of conventional flowable resin composite. A 5-minute waiting period will be allowed before completion of the composite restoration. |
Immediate dentin sealing using a universal adhesive system with a selective enamel-etching strategy, followed by application of a 0.5-1.0 mm layer of conventional flowable resin composite and a 5-minute waiting period before completion of the posterior composite restoration. |
|
Comparador activo: Conventional Composite Group
Participants assigned to this group will receive a conventional Class II posterior composite restoration without the decoupling with time procedure or the additional 5-minute waiting period. |
Conventional Class II posterior composite restoration without the decoupling with time procedure. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Postoperative Hypersensitivity
Periodo de tiempo: Pre-operatively, 1 week, 6 months, 12 months, and 18 months after restoration placement.
|
Postoperative hypersensitivity will be assessed clinically using the Modified United States Public Health Service (USPHS) criteria. The assessment will be performed before the restorative procedure and at the specified follow-up visits after restoration placement. |
Pre-operatively, 1 week, 6 months, 12 months, and 18 months after restoration placement.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Clinical Performance of Posterior Composite Restorations
Periodo de tiempo: Immediately after restoration placement, 6 months, 12 months, and 18 months after restoration placement.
|
Clinical performance of the restorations will be evaluated using the Modified United States Public Health Service (USPHS) criteria. The evaluated parameters will include marginal integrity, fracture and retention, marginal discoloration, anatomic form, proximal contact, surface texture, radiographic evaluation, and secondary caries. |
Immediately after restoration placement, 6 months, 12 months, and 18 months after restoration placement.
|
|
Total Operative Time
Periodo de tiempo: During the restorative procedure.
|
The total time required to complete each restorative procedure will be measured in minutes using a digital stopwatch, starting from the beginning of the restorative procedure and ending upon completion of the restoration. |
During the restorative procedure.
|
Colaboradores e Investigadores
Patrocinador
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
- Cons-DWT-C.Perf-2026
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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