Effect of Different Resin Composite Packing Techniques on Pulp Condition (Randomized Clinical Trial)
4 de julio de 2026 actualizado por: Esraa Mohamed Zaki, October 6 University
The goal of this clinical trial is to evalute the effect of different resin composite packing techniques on pulpal condition in patient with deep carious occlusal cavities in their molar teeth. The main questions it aims to answer are:
- Do composite packing technquies cause pulpal inflammatory response ?
- Do composite packing technquies cause post operative pain ? Researchers will compare elastic cavity liner packing techniques to sonic activated and flowable bulk packing techniques to see their effect on pulp condition.
Participants will :
- Provide an honest medial and dental history to undergo the restorative procedures .
- Report subjective symptons.
- Attend all scheduled follow-ups visit for pulp assessment.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
This clinical study evaluates the impact of various resin composite packing techniques on pulp inflammation and post-operative condition, specifically comparing the biological and mechanical outcomes of incremental layering of packable composite with flowable liner versus modern bulk-fill strategies as SoniFill bulk fill resin composite and SDR bulk fill composite.
The research involves preparing standardized cavities in clinical participants and restoring them using specialized resin materials to determine how different application methods influence polymerization shrinkage stress, marginal adaptation, and dentinal tubule fluid movement.
To quantify the subclinical inflammatory response of the pulp, Gingival Crevicular Fluid (GCF) samples are collected from the gingival sulcus of the restored teeth at baseline and specific post-operative intervals (immediately and after one week ) to analyze changes in inflammatory mediators or biomarkers.
Simultaneously, the patient's subjective experience of post-operative pain and thermal sensitivity is recorded using the Visual Analog Scale (VAS), where participants mark their level of discomfort on a 10-cm line to provide measurable data on clinical symptoms.
By correlating these objective biochemical markers from the GCF with the subjective VAS scores and clinical sensibility testing, the study aims to identify the most effective packing protocol for minimizing C-factor-related stress and protecting the dentin-pulp complex from inflammatory responses.
Tipo de estudio
Intervencionista
Inscripción (Actual)
30
Fase
- Fase 4
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.
Ubicaciones de estudio
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Giza, Egipto, 3235142
- Ain Shams University
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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
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Both genders.
- Systemically healthy patients.
- Good oral hygiene.
- Available for follow-up appointments.
- Asymptomatic permanent molars with deep occlusal caries ICDAS 5 or 6 carious lesions and healthy periodontium, in normal occlusion with no previous restorations related to the teeth and vital with a positive response to cold testing.
Exclusion Criteria:
- Vulnerable populations.
- Tobacco users.
- Medically compromised patients, such as those with diabetes or medications affecting salivary flow were excluded.
- Teeth with prior endodontic treatment, periodontal pockets over 3 mm, or any dental/periodontal therapy within the past 12 months.
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: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Sin intervención: Flowable liner and packable composite
Following proper administration of local anesthesia , cavity preparation is completed according to the study's standardized dimensions.
Isolation is achieved using a rubber dam to ensure a moisture-free operating field.
Selective-etch is performed using 37% phosphoric acid, followed by thorough rinsing and gentle air-drying to leave the dentin moist.
The bonding agent is applied according to the manufacturer's instructions, gently air-thinned to form a uniform layer, and light-cured for the specified duration.
A low-viscosity flowable composite liner is applied to the pulpal floor generally not exceeding 1-2 mm in thickness.
he remaining cavity depth is restored using a packable resin composite using an incremental layering technique to minimize polymerization shrinkage stress.
Each increment is meticulously adapted to the cavity walls using a hand plugger, anatomically contoured, and light-cured individually from the occlusal surface.
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Experimental: Sonic Fill bulk fill resin composite
The SonicFill bulk-fill resin composite is delivered directly into the cavity preparation using its specialized, ultrasonically activated handpiece. The material is placed in a single bulk increment of up to 5 mm, completely filling the cavity to the occlusal margin. Once the sonic activation stops, the material reverts to a sculptable, non-slumping consistency, allowing immediate anatomical contouring. The entire bulk increment is then light-cured from the occlusal surface according to the manufacturer's recommended exposure time and intensity. |
The SonicFill bulk-fill resin composite is delivered directly into the cavity preparation using its specialized, ultrasonically activated handpiece.
The material is placed in a single bulk increment of up to 5 mm, completely filling the cavity to the occlusal margin.
Once the sonic activation stops, the material reverts to a sculptable, non-slumping consistency, allowing immediate anatomical contouring.
The entire bulk increment is then light-cured from the occlusal surface according to the manufacturer's recommended exposure time and intensity
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Experimental: SDR flowable bulk fill resin composite
SDR bulk-fill flowable composite is dispensed directly into the cavity using the manufacturer's syringe tip, starting from the deepest part of the preparation to avoid air entrapment. Due to its self-leveling properties and low polymerization stress, it is placed in a single bulk increment of up to 4 mm, leaving approximately 1.5-2 mm of occlusal space for the capping layer. The material is then light-cured. The remaining occlusal volume is restored using a conventional packable resin composite to act as the wear-resistant enamel replacement. Then the capping layer is adapted to the cavosurface margins, anatomically contoured to replicate correct tooth morphology, and light-cured. |
SDR bulk-fill flowable composite is dispensed directly into the cavity using the manufacturer's syringe tip, starting from the deepest part of the preparation to avoid air entrapment.
Due to its self-leveling properties and low polymerization stress, it is placed in a single bulk increment of up to 4 mm, leaving approximately 1.5-2 mm of occlusal space for the capping layer.
The material is then light-cured.
The remaining occlusal volume is restored using a conventional packable resin composite to act as the wear-resistant enamel replacement.
Then the capping layer is adapted to the cavosurface margins, anatomically contoured to replicate correct tooth morphology, and light-cured.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Pulpal inflammatory responses.
Periodo de tiempo: From enrollment to the end of treatment at one year.
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Immuno-histological analysis of the crevicular fluid to evalute pulpal inflammatory response by quantifying the volume of the pro-inflammatory cytokine TNF-α in GCF that reflect pulpal inflmmation in response to different resin composite packing techniques.
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From enrollment to the end of treatment at one year.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Post-operative pain.
Periodo de tiempo: From enrollment to the end of treatment at one year.
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This evaluation is conducted using the Visual Analog Scale (VAS), a validated 10-cm horizontal line where "0" represents "no pain" and "10" represents "the worst imaginable pain."
Participants are instructed to record their subjective perception of discomfort at specific post-operative intervals (before treatment and one week following restorative procedures ).
To ensure a comprehensive assessment, pain is categorized into spontaneous pain and provoked pain (sensitivity to thermal stimuli or masticatory pressure).
This subjective data is then correlated with the biochemical findings from the Gingival Crevicular Fluid (GCF) samples.
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From enrollment to the end of treatment at one year.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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 febrero de 2025
Finalización primaria (Actual)
1 de enero de 2026
Finalización del estudio (Actual)
1 de enero de 2026
Fechas de registro del estudio
Enviado por primera vez
4 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
4 de julio de 2026
Publicado por primera vez (Actual)
10 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
10 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
4 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- FDASU-Rec IM012562
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
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