Retention and Caries Prevention of Giomer Sealant With or Without Diode Laser Pre-treatment: A Randomized Controlled Trial
Retention Rate and Caries Prevention of Giomer Based Sealant With and Without Diode Laser Pre-treatment in Young Adults: A Randomized Controlled Trial
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The protocol investigates whether diode laser pre-treatment can improve the clinical performance of a giomer-based fissure sealant in young adults. The study is designed as a two-arm randomized controlled clinical trial evaluating sealant retention and caries prevention over a 12-month period.
The background emphasizes that pits and fissures of posterior teeth are highly susceptible to caries, and fissure sealants are an evidence-based preventive approach. Giomer sealants combine the advantages of resin composites and glass ionomer materials through S-PRG filler technology, offering fluoride release and simplified application using self-etch primer systems. However, concerns remain regarding their long-term retention. Diode laser enamel pre-treatment is proposed to enhance enamel surface roughness, improve sealant penetration, and increase resistance to acid dissolution, potentially improving retention and caries prevention.
The study aims to compare giomer-based sealant application with and without diode laser pre-treatment in patients aged 17-22 years having deep retentive fissures with ICDAS scores 0-2 in second and third molars. Primary outcome is sealant retention assessed using Simonsen's criteria, while secondary outcome is caries prevention evaluated using modified USPHS criteria at baseline, 6 months, and 12 months.
The null hypothesis states that diode laser pre-treatment will not significantly affect retention rate or caries prevention compared with conventional application. The protocol includes detailed sample size calculation based on previous literature, resulting in 37 teeth per group after adjustment for dropouts. Statistical analysis will include chi-square and Cochran's Q tests with significance set at p ≤ 0.05.
Eligibility criteria include healthy young adults with good oral hygiene and absence of parafunctional habits. Teeth with fractures, existing restorations, secondary caries, developmental defects, or periodontal compromise are excluded.
Methodologically, participants are randomly allocated using opaque sealed envelopes. In the control group, self-etch primer is applied before placement of BeautiSealant. In the laser group, a 940-nm diode laser is first applied to the occlusal surface, followed by the same primer and sealant application protocol. All restorations are light-cured and clinically evaluated for voids and occlusion
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Cairo, Egipto
- Faculty of Dentistry
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Cairo, Egipto
- Yomna
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Cairo, Egipto
- Faculty of Dentistry Cairo University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
Young adult Patients Aged 17-22.
- Good oral hygiene (plaque index score 0 or 1).
- Absence of abnormal occlusion habits (e.g. bruxism, nail biting, tooth clenching and mouth breathing).
- Patients approving to participate in the study.
Exclusion Criteria:
•Patients with known allergic or adverse reaction to the tested materials.
- Systematic disease that may affect participation.
- Xerostomic patients.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: Giomer Based Sealant Without Pre Treatmen
Giomer Based Sealant Without Pre Treatment With laser giomer based fissure sealnt will be applied without surface treatment
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surface treatment with Bioactive Glass Air Abrasion giomer based fissure sealnt will be applied after surface treatment With laser
Otros nombres:
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Comparador activo: Giomer Based Sealant With etchant Pre Treatmen
Giomer Based Sealant Without Pre Treatment With laser giomer based fissure sealnt will be applied with phosphoric acid surface treatment
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surface treatment with Bioactive Glass Air Abrasion giomer based fissure sealnt will be applied after surface treatment With laser
Otros nombres:
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Comparador activo: Giomer Based Sealant With laser Pre Treatmen
Giomer Based Sealant with laser Pre Treatment giomer based fissure sealnt will be applied with laser surface treatment
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surface treatment with Bioactive Glass Air Abrasion giomer based fissure sealnt will be applied after surface treatment With laser
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Loss of sealant's retention
Periodo de tiempo: 1 year
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Simonsen's criteria Full retention (FR) The material was fully present on the occlusal surfaces Partially lost (PL) The material was present, but as a result of either wear or loss of the material, part of a previously sealed pit or fissure, or both, was exposed- Totally lost (TL) No trace of the material was detected on the surface.
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1 year
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Secondary Caries
Periodo de tiempo: 1 year
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Modified USPHS ( United States Public Health Service) criteria Alpha: Absence of the caries Charlie: Presence of the caries
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1 year
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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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Fissure sealant
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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