Effect of Ozone Therapy on Remineralization of Initial Caries Lesions in Children (OZONE-CARIES)
Effect of Ozone Therapy on the Remineralization of Initial Caries Lesions in Children: A Randomized Controlled Clinical Trial
Initial caries lesions can be managed using non-invasive treatment approaches that promote remineralization and prevent lesion progression. Ozone therapy has been suggested as an adjunctive treatment because of its antimicrobial properties and its potential to enhance remineralization.
This randomized controlled clinical trial aims to evaluate the effect of ozone therapy on the remineralization of initial caries lesions in children. Participants will be randomly assigned to receive either ozone therapy followed by application of a remineralizing gel or application of the remineralizing gel alone.
Changes in lesion status will be assessed over time using clinical and optical evaluation methods. The results of this study may contribute to the development of evidence-based minimally invasive approaches for the management of early caries lesions in pediatric patients.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Dental caries remains one of the most common chronic diseases affecting children worldwide. Initial non-cavitated caries lesions represent a reversible stage of the disease and provide an opportunity for non-invasive treatment through remineralization strategies.
Ozone therapy has attracted interest in pediatric dentistry because of its antimicrobial effects and its potential to improve conditions for remineralization. However, evidence regarding its clinical effectiveness as an adjunct to remineralizing agents remains limited.
The aim of this prospective randomized controlled clinical trial is to evaluate the effectiveness of ozone therapy in the management of initial caries lesions in children.
Eligible participants with initial non-cavitated caries lesions will be randomly allocated to one of two study groups. The intervention group will receive ozone therapy followed by application of ROCS Medical Minerals remineralizing gel, while the control group will receive ROCS Medical Minerals remineralizing gel alone.
Participants will be evaluated at baseline and during follow-up visits according to the study protocol. Changes in lesion characteristics and remineralization outcomes will be monitored using clinical and optical assessment methods.
The primary objective of the study is to determine whether adjunctive ozone therapy provides additional benefit in promoting remineralization compared with remineralizing gel alone. The findings may provide further evidence regarding minimally invasive management of early caries lesions in children.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Neslihan Atmaca, Doctor of Dental Surgery
- Número de teléfono: +905458314053
- Correo electrónico: nsltmc@gmail.com
Ubicaciones de estudio
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Maltepe
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Istanbul, Maltepe, Turquía (Türkiye), 34854
- Reclutamiento
- Marmara Universty School of Dentistry
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Contacto:
- Neslihan Atmaca, Doctor of Dental Surgery
- Número de teléfono: +905458314053
- Correo electrónico: nsltmc@gmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Descripción
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Ozone Group
Participants receive ozone therapy followed by ROCS Medical Minerals gel application for the management of initial caries lesions.
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Ozone therapy administered using the Ozonytron device for the treatment of initial caries lesions.
ROCS Medical Minerals gel applied according to the manufacturer's instructions for remineralization of initial caries lesions.
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Comparador activo: Control Group
Participants receive ROCS Medical Minerals gel alone for the management of initial caries lesions.
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ROCS Medical Minerals gel applied according to the manufacturer's instructions for remineralization of initial caries lesions.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Quantitative Light-Induced Fluorescence (QLF) fluorescence loss (ΔF) values of initial caries lesions
Periodo de tiempo: Baseline, Weeks 1, 2, 3, 4, and Week 8
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Fluorescence loss (ΔF) values of each initial caries lesion will be assessed using the QrayCam Pro system at baseline and follow-up visits (Weeks 1, 2, 3, 4, and 8).
The outcome will be reported as the change in ΔF values from baseline to each follow-up visit.
Lower ΔF values indicate greater remineralization, reflecting reduced mineral loss.
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Baseline, Weeks 1, 2, 3, 4, and Week 8
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in DIAGNOdent Pen laser fluorescence values of initial caries lesions
Periodo de tiempo: Baseline, Weeks 1, 2, 3, 4, and Week 8
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Laser fluorescence values of each initial caries lesion will be assessed using the DIAGNOdent Pen at baseline and follow-up visits (Weeks 1, 2, 3, 4, and 8).
The outcome will be reported as the change in DIAGNOdent Pen values from baseline to each follow-up visit.
Lower DIAGNOdent values indicate reduced lesion severity and improved lesion status.
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Baseline, Weeks 1, 2, 3, 4, and Week 8
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Change in the clinical appearance of initial caries lesions assessed using standardized intraoral photographs
Periodo de tiempo: Baseline, Weeks 1, 2, 3, 4, and Week 8
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The clinical appearance of each initial caries lesion will be assessed using standardized intraoral photographs obtained at baseline and follow-up visits (Weeks 1, 2, 3, 4, and 8).
The outcome will be reported as changes in lesion appearance from baseline to each follow-up visit using predefined clinical evaluation criteria.
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Baseline, Weeks 1, 2, 3, 4, and Week 8
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- MUPEDDENTNSL-2
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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