The Effect of Ozone Therapy on Salivary Flow and Quality of Life in Patients With Xerostomia and Hyposalivation After Head and Neck Radiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- Salivary flow
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have undergone head and neck radiotherapy
- •Patient who have developed xerostomia
- •Patient who have developed hyposalivation
排除标准
- •Patients with active malignant disease
- •Patients who do not agree to sign the informed consent form
研究组 & 干预措施
ozone therapy
Ozone gas will be applied as follows:
- Parotid glands: two distinct points per gland, 1 mL at each point (10 µg/mL). The anatomical reference will be the parotid region, located anterior and inferior to the external ear.
- Submandibular glands: one point per gland, 1 mL at 10 µg/mL. The anatomical reference will be the mandibular base, anterior to the angle, considering its inner aspect.
- Sublingual glands: one point per gland, 1 mL at 10 µg/mL. The anatomical reference will be the region of the lower lateral incisor, lingual aspect, punctured through the floor of the mouth mucosa, adjacent to the lingual surface of the mandibular bone.
The ozone generator (Dental model, Philozon, Brazil) will be supplied with medical oxygen (99.5% purity).
干预措施: Ozone therapy (Other)
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
结局指标
主要结局
Salivary flow
时间窗: 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.
Salivary flow
时间窗: 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.
Salivary Flow
时间窗: 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.
Salivary flow
时间窗: 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.
Salivary flow
时间窗: 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.
次要结局
- Xerostomia-Related Quality of Life Scale (XeQoLS)(time 0 weeks)
- Xerostomia-Related Quality of Life Scale (XeQoLS)(time 6 weeks)
- Xerostomia-Related Quality of Life Scale (XeQoLS)(time 12 weeks)
- Oral Health Impact Profile-14 (OHIP-14)(time 0 weeks)
- Oral Health Impact Profile-14 (OHIP-14)(time 6 weeks)
- Oral Health Impact Profile-14 (OHIP-14)(time 12 weeks)
研究者
Sergio Bruzadelli Macedo
Clinical Professor
University of Brasilia