Pain Perception of Novel Chemo-mechanical Caries Remove Versus Atraumatic Restorative Treatment Method in Primary Molars
The goal of this clinical trial is to compare pain Perception, patient acceptability, and cavity preparation time between chemo-mechanical caries removal and Atraumatic restorative treatment Method in Primary Molars.
The main questions it aims to answer: "Does chemo-mechanical caries removal show similar results compared to Atraumatic restorative treatment Method in terms of pain perception in Primary Molars?
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The principles of the caries removal have changed greatly in the last decade. The use of local anesthesia with conventional techniques "high-speed hand piece" increase the fear and anxiety of the child. Minimally invasive techniques reduce the pain and anxiety of the child by eliminating the use of local anesthesia
Atraumatic Restorative Treatment (ART) is one of the approaches based on this philosophy. It involves the manual removal of carious tissue without the use of local anesthesia or rotary instruments, followed by restoration with glass ionomer cement, an adhesive material that chemically bonds to tooth structure and releases fluoride, promoting remineralization.
Chemo mechanical caries removal (CMCR) is another minimally invasive technique that utilizes chemical agents with proteolytic action to degrade denatured collagen within carious dentin, facilitating its removal without the need for rotary instruments. This technique reduces pain, discomfort, and anxiety, making it particularly suitable for pediatric patients. Additionally, CMCR minimizes the risk of unnecessary removal of healthy tooth structure and may reduce the need for local anesthesia, thereby improving patient cooperation and the overall treatment experience.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Maram Malik Osman Alabd, Bachelor of dental science
- Número de teléfono: 00201279666507
- Correo electrónico: maram.alabd@dentistry.cu.edu.eg
Copia de seguridad de contactos de estudio
- Nombre: Manal Ahmed Elsheikh, prof, PhD
Ubicaciones de estudio
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Cairo, Egipto, 12613
- Faulty of Dentistry Cairo University
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Contacto:
- Faculty of Dentistry Cairo university
- Número de teléfono: 00201279666507
- Correo electrónico: rec@dentistry.cu.edu.eg
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Healthy children aged between 5 and 9 years.
- Children presenting with occlusal caries in mandibular and/or maxillary primary molars Carious lesions without any pulpal involvement.
- Children whose parents or guardians have provided written informed consent.
Exclusion Criteria:
1-Children with teeth exhibiting: pulpal exposure, mobility, spontaneous pain, swelling or fistula adjacent to the tooth, furcation involvement, ervical lesions, teeth with sealants, restorations, or enamel defects also exclude .
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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Experimental: Group A: Chemo-Mechanical Caries Removal (CMCR)
Participants in this arm will receive chemo-mechanical caries removal using REMOVE gel.
The procedure includes cleaning the tooth surface with wet cotton pellets, application of REMOVE gel into the cavity, and allowing it to act for approximately 30 seconds.
The softened carious tissue is then removed gently without pressure.
Remaining Caries become fluorescence under light cure source, and the absence of color change indicates complete removal.
Residual gel is removed using sterile wet cotton pellets.
Finally, the cavity is restored with high-viscosity glass ionomer cement (Fuji IX, GC Corporation, Tokyo, Japan) according to the manufacturer's instructions.
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Removal of dental caries using REMOVE gel followed by restoration with high-viscosity glass ionomer cement (Fuji IX)
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Experimental: Group B: Atraumatic Restorative Treatment (ART)
Participants in this arm will receive atraumatic restorative treatment (ART).
The procedure involves opening the cavity and removal of carious dentin using a dental excavator .
The cavity is clinically evaluated using a sharp explorer, and caries removal is considered complete when the explorer does not stick to dentin or produce a tug-back sensation.
The cavity is then restored with high-viscosity glass ionomer cement (Fuji IX, GC Corporation, Tokyo, Japan) according to the manufacturer's instructions.
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Removal of dental caries using hand instruments followed by restoration with high-viscosity glass ionomer cement (Fuji IX)
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Pain Perception Measured by Visual Analog Scale (VAS)
Periodo de tiempo: immediately after caries removal
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Pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst possible pain). Higher scores represent greater pain intensity. 0: No pain 1-3: mild 4-5: moderate 6-7: Severe 8-9: very severe 10: Worst Pain possible |
immediately after caries removal
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Patient Acceptability Assessed by Likert Scale
Periodo de tiempo: Immediately after treatment procedure
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Patient acceptability will be evaluated using a 5-point Likert Scale ranging from 1 to 5, where 1 indicates very happy and 5 indicates very unhappy. Higher scores indicate lower patient acceptability.
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Immediately after treatment procedure
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Caries removal time measured by stopwatch per minutes
Periodo de tiempo: During the caries removal procedure
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The duration of the treatment procedure will be measured in minutes from the beginning of caries removal until completion of the restorative procedure.
Higher values indicate longer treatment time.
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During the caries removal procedure
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- -Abdel Sattar, R., Nasr, R., Hanafy, R. (2026). 'Pain Assessment During Chemo-Mechanical and Smart Burs Caries Removal Versus Atraumatic Restorative Treatment in Carious Primary Molars: A Randomized Clinical Trial', Egyptian Dental Journal, 72(1), pp. 25-33. doi: 10.21608/edj.2025.417407.3615
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
Otros números de identificación del estudio
- PP-NCV-VSART
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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