The Effect of Ozone on Salivary Flow in Patients With Xerostomia and Hyposalivation After Radiotherapy (OZONEXEROSTOMI) (ozonexerostomi)
The Effect of Ozone Therapy on Salivary Flow and Quality of Life in Patients With Xerostomia and Hyposalivation After Head and Neck Radiotherapy
Patients who underwent head and neck radiotherapy and developed xerostomia and/or hyposalivation will be selected. The patients will be randomly assigned into two groups, defined as control and treatment.
All patients will complete the xerostomia-related quality of life questionnaires, XeQoLS (Xerostomia Quality of Life Scale) and OHIP (Oral Health Impact Profile). This qualitative assessment will be repeated 1 week after the 6th application and 1 week after the 12th application (T0, T6, and T12).
The quantitative assessment will be carried out through the collection of unstimulated and stimulated saliva at the same time points (T0, T6, and T12).
Patients will undergo 12 sessions of ozone therapy, once a week, in gaseous form, at a concentration of 10 µg/mL (micrograms per milliliter), applied directly into the major salivary glands.
The gas will be administered as follows:
- Parotid glands: two distinct points per gland, 1 mL at each point.
- Submandibular glands: one point per gland, 1 mL per point at 10 µg/mL.
- Sublingual glands: one point per gland, 1 mL per point at 10 µg/mL. The ozone generator equipment will be supplied with medical oxygen (99.5% purity), Dental model, Philozon company.
Disposable syringes will be Terumo, 10 mL, and the needle will be BD, 30/13 mm.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Sergio B Macedo, PhD
- Número de teléfono: +5561981276050
- Correo electrónico: bruzadelli@unb.br
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Patients who have undergone head and neck radiotherapy
- Patient who have developed xerostomia
- Patient who have developed hyposalivation
Exclusion Criteria:
- Patients with active malignant disease
- Patients who do not agree to sign the informed consent form
Plan de estudios
¿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 |
|---|---|
|
Experimental: ozone therapy
Ozone gas will be applied as follows:
The ozone generator (Dental model, Philozon, Brazil) will be supplied with medical oxygen (99.5% purity). |
Experimental: Ozone Therapy Ozone gas will be applied as follows:
The ozone generator (Dental model, Philozon, Brazil) will be supplied with medical oxygen (99.5% purity). |
|
Sin intervención: no treatment
Patients in the control group will not receive any treatment but will complete the xerostomia-related quality of life questionnaires and undergo salivary flow assessment at T0, T6, and T12
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Salivary flow
Periodo de tiempo: Time 0 weeks
|
The assessment of unstimulated salivary flow will be conducted according to the technique described by Kogawa et al., 2016. The patient will receive a sterile vial, keep the body slightly leaning forward, place the vial touching the lower lip, and allow saliva to flow into the vial spontaneously for 5 minutes. The unit of measurement will be in microliters. |
Time 0 weeks
|
|
Salivary flow
Periodo de tiempo: time 6 weeks
|
The assessment of unstimulated salivary flow will be conducted according to the technique described by Kogawa et al., 2016. The patient will receive a sterile vial, keep the body slightly leaning forward, place the vial touching the lower lip, and allow saliva to flow into the vial spontaneously for 5 minutes. The unit of measurement will be in microliters. |
time 6 weeks
|
|
Salivary Flow
Periodo de tiempo: 12 week
|
The assessment of unstimulated salivary flow will be conducted according to the technique described by Kogawa et al., 2016.
The patient will receive a sterile vial, keep the body slightly leaning forward, place the vial touching the lower lip, and allow saliva to flow into the vial spontaneously for 5 minutes.
The unit of measurement will be in microliters.
|
12 week
|
|
Salivary flow
Periodo de tiempo: Time 0 weeks
|
The assessment of stimulated salivary flow will be conducted according to the technique described by Kogawa et al., 2016.
The patient will receive a sterile vial, keep the body slightly leaning forward, place the vial touching the lower lip, and allow saliva to flow into the vial spontaneously for 5 minutes.
Stimulated saliva will be collected using the same procedure, preceded by chewing a piece of silicone for 1 minute.
The unit of measurement will be in microliters.
|
Time 0 weeks
|
|
Salivary flow
Periodo de tiempo: Time 6 weeks
|
The assessment of stimulated salivary flow will be conducted according to the technique described by Kogawa et al., 2016.
The patient will receive a sterile vial, keep the body slightly leaning forward, place the vial touching the lower lip, and allow saliva to flow into the vial spontaneously for 5 minutes.
Stimulated saliva will be collected using the same procedure, preceded by chewing a piece of silicone for 1 minute.
The unit of measurement will be in microliters.
|
Time 6 weeks
|
|
Salivary flow
Periodo de tiempo: Time 12 weeks
|
The assessment of stimulated salivary flow will be conducted according to the technique described by Kogawa et al., 2016.
The patient will receive a sterile vial, keep the body slightly leaning forward, place the vial touching the lower lip, and allow saliva to flow into the vial spontaneously for 5 minutes.
Stimulated saliva will be collected using the same procedure, preceded by chewing a piece of silicone for 1 minute.
The unit of measurement will be in microliters.
|
Time 12 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Xerostomia-Related Quality of Life Scale (XeQoLS)
Periodo de tiempo: time 0 weeks
|
The Xerostomia-Related Quality of Life Scale (XeQoLS) consists of 15 items, each scored from 0 to 4 according to the severity of xerostomia impact.
The final score is calculated as the mean of all items, resulting in a total score ranging from 0 to 4, where 0 indicates no impact and 4 indicates maximum impact.
Higher scores indicate worse xerostomia-related quality of life.
|
time 0 weeks
|
|
Xerostomia-Related Quality of Life Scale (XeQoLS)
Periodo de tiempo: time 6 weeks
|
The Xerostomia-Related Quality of Life Scale (XeQoLS) consists of 15 items, each scored from 0 to 4 according to the severity of xerostomia impact.
The final score is calculated as the mean of all items, resulting in a total score ranging from 0 to 4, where 0 indicates no impact and 4 indicates maximum impact.
Higher scores indicate worse xerostomia-related quality of life.
|
time 6 weeks
|
|
Xerostomia-Related Quality of Life Scale (XeQoLS)
Periodo de tiempo: time 12 weeks
|
The Xerostomia-Related Quality of Life Scale (XeQoLS) consists of 15 items, each scored from 0 to 4 according to the severity of xerostomia impact.
The final score is calculated as the mean of all items, resulting in a total score ranging from 0 to 4, where 0 indicates no impact and 4 indicates maximum impact.
Higher scores indicate worse xerostomia-related quality of life.
|
time 12 weeks
|
|
Oral Health Impact Profile-14 (OHIP-14)
Periodo de tiempo: time 0 weeks
|
The Oral Health Impact Profile-14 (OHIP-14) is a validated questionnaire consisting of 14 items assessing the impact of oral health on quality of life. Each item is scored from 0 to 4 based on frequency of impact (0 = never, 1 = hardly ever, 2 = occasionally, 3 = fairly often, 4 = very often). The total score is calculated as the sum of all items, ranging from 0 to 56, with higher scores indicating worse oral health-related quality of life. |
time 0 weeks
|
|
Oral Health Impact Profile-14 (OHIP-14)
Periodo de tiempo: time 6 weeks
|
The Oral Health Impact Profile-14 (OHIP-14) is a validated questionnaire consisting of 14 items assessing the impact of oral health on quality of life. Each item is scored from 0 to 4 based on frequency of impact (0 = never, 1 = hardly ever, 2 = occasionally, 3 = fairly often, 4 = very often). The total score is calculated as the sum of all items, ranging from 0 to 56, with higher scores indicating worse oral health-related quality of life. |
time 6 weeks
|
|
Oral Health Impact Profile-14 (OHIP-14)
Periodo de tiempo: time 12 weeks
|
The Oral Health Impact Profile-14 (OHIP-14) is a validated questionnaire consisting of 14 items assessing the impact of oral health on quality of life. Each item is scored from 0 to 4 based on frequency of impact (0 = never, 1 = hardly ever, 2 = occasionally, 3 = fairly often, 4 = very often). The total score is calculated as the sum of all items, ranging from 0 to 56, with higher scores indicating worse oral health-related quality of life. |
time 12 weeks
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
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Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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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
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Última actualización enviada que cumplió con los criterios de control de calidad
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Palabras clave
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Otros números de identificación del estudio
- 66681722.6.0000.0030
Plan de datos de participantes individuales (IPD)
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- PROTOCOLO DE ESTUDIO
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