Dry-Shield vs Rubber Dam During Fissure Sealant Placement (DRY-SEAL)
Efficiency of Using Dry-Shield and Rubber Dam Isolation on Fissure Sealant Application in Permanent Molars: A Randomized Clinical Trial
This randomized clinical trial aims to evaluate the efficiency of the Dry-Shield isolation system compared with rubber dam isolation and cotton roll isolation during fissure sealant application in permanent molars among pediatric patients.
The study evaluates chairside time, patient preference, and fissure sealant retention rates after 6 and 12 months of follow-up. Proper isolation during fissure sealant application is considered essential for optimal retention and long-term clinical success.
The study also aims to assess whether Dry-Shield can provide a practical and comfortable alternative to conventional isolation techniques in pediatric dentistry.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Fissure sealants are widely used preventive measures for reducing occlusal caries in permanent molars. Successful sealant retention largely depends on adequate moisture control during application. Rubber dam isolation has traditionally been considered the gold standard for moisture control; however, its use in pediatric dentistry may be associated with increased chair time and patient discomfort.
Dry-Shield is an isolation device that combines suction, tongue retraction, bite block support, and moisture control in a single system. This may improve clinical efficiency and patient comfort during dental procedures.
This randomized clinical trial compares the Dry-Shield isolation system with rubber dam isolation and cotton roll isolation during fissure sealant application in permanent molars in children. The study evaluates clinical efficiency through assessment of chairside time, patient preference, and fissure sealant retention at 6 and 12month follow-ups.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Ismailia Governorate
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Ismailia, Ismailia Governorate, Egipto, 41522
- Faculty of Dentistry, Suez Canal University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
A- Patient inclusion criteria:
- Cooperative, apparently healthy children.
- Each child had at least three fully erupted first and/or second permanent molars.
- Patient being at high risk of dental caries.
- Informed consent was filled before treatment.
B- Molar inclusion criteria:
- Tooth had deep pits and fissures.
- Molars with the International Caries Detection and Assessment System (ICDAS) score 0-2.
- All three molars required PFS.
Exclusion Criteria:
A- Patient exclusion criteria:
- Uncooperative children.
- Children with special needs.
- Children who required emergency dental care (draining sinus, abscess and cellulitis).
- Who were suffering from an allergy to latex or a severe gag reflex.
- Mouth breather or child with nasal obstruction.
- Children with fixed orthodontic.
B- Molar exclusion criteria:
- Previous restored or carious first or second permanent molars.
- Molars with anomalies of the enamel or dentin.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Group 1: Dry-Shield Isolation
Participants receive pit and fissure sealant using Dry-Shield isolation system in a split-mouth design.
|
Application of a fluoride-releasing, resin-based pit and fissure sealant (Conseal F) on eligible permanent molars to evaluate and compare the clinical efficiency of three different isolation methods.
|
|
Comparador activo: Group 2: Rubber Dam Isolation
Participants receive pit and fissure sealant using rubber dam isolation technique in a split-mouth design.
|
Application of a fluoride-releasing, resin-based pit and fissure sealant (Conseal F) on eligible permanent molars to evaluate and compare the clinical efficiency of three different isolation methods.
|
|
Comparador activo: Group 3: Cotton Roll Isolation
Participants receive pit and fissure sealant using cotton roll isolation technique in a split-mouth design
|
Application of a fluoride-releasing, resin-based pit and fissure sealant (Conseal F) on eligible permanent molars to evaluate and compare the clinical efficiency of three different isolation methods.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Sealant Retention Rate
Periodo de tiempo: 6 months and 12 months
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Evaluation of fissure sealant retention using Simonsen criteria after 6 and 12 months.
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6 months and 12 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Chairside Time
Periodo de tiempo: Immediately during procedure
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Assessment of the time required for fissure sealant application using each isolation technique
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Immediately during procedure
|
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Patient Preference and discomfort
Periodo de tiempo: Immediately after procedure
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Assessment of patient preference and discomfort using a questionnaire and Wong-Baker FACES pain rating scale after fissure sealant placement
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Immediately after procedure
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- SCU-PEDO-RCT-2025
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan 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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