An interventional study of Ozone therapy in Xerostomia Following Radiotherapy, sponsored by University of Brasilia. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-06.
Sponsored by University of Brasilia · Not applicable, Interventional, and Treatment
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:
Disposable syringes will be Terumo, 10 mL, and the needle will be BD, 30/13 mm.
286 studies on the registry are indexed under Xerostomia; 51 are open to participants now.
This study's planned enrollment of 100 is above the median of 44 across 235 interventional studies indexed under Xerostomia.
Browse Xerostomia studies →University of Brasilia is the lead sponsor of 66 studies on the registry; 12 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Other: Ozone therapy
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
Experimental: 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).
Salivary flow
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 frame: Time 0 weeks
Salivary flow
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 frame: time 6 weeks
Salivary Flow
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 frame: 12 week
Salivary flow
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 frame: Time 0 weeks
Salivary flow
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 frame: Time 6 weeks
Salivary flow
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 frame: Time 12 weeks
Xerostomia-Related Quality of Life Scale (XeQoLS)
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 frame: time 0 weeks
Xerostomia-Related Quality of Life Scale (XeQoLS)
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 frame: time 6 weeks
Xerostomia-Related Quality of Life Scale (XeQoLS)
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 frame: time 12 weeks
Oral Health Impact Profile-14 (OHIP-14)
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 frame: time 0 weeks
Oral Health Impact Profile-14 (OHIP-14)
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 frame: time 6 weeks
Oral Health Impact Profile-14 (OHIP-14)
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 frame: time 12 weeks
No study locations are listed for this record.
Plan to share: Yes — Individual data will be made available as supplementary material in the final publication.
Supporting information: Study protocol
No publications or documents are linked to this record.
Start is estimated for Jul 2026; primary completion for Jul 2027, 12 months later.
Of 85 non-industry interventional studies with no phase under Xerostomia, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 33. This study's planned 12 months is below that.
Counting every sponsor, half of 101 studies reached it within 13 months; a quarter within 4 and three quarters within 33.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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University of Brasilia