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NCT Number: NCT07571356

The Effect of Ozone on Salivary Flow in Patients With Xerostomia and Hyposalivation After Radiotherapy (OZONEXEROSTOMI)

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.

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Key information

Conditions

Xerostomia Following Radiotherapy Mouth Diseases Salivary Gland Diseases Stomatognathic Diseases Xerostomia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ozone therapy

Other

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).

Primary outcomes

  1. Salivary flow

    Time frame: 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.

  2. Salivary flow

    Time frame: 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.

  3. Salivary Flow

    Time frame: 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.

  4. Salivary flow

    Time frame: 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.

  5. Salivary flow

    Time frame: 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.

  6. Salivary flow

    Time frame: 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.

Secondary outcomes

  1. Xerostomia-Related Quality of Life Scale (XeQoLS)

    Time frame: 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.

  2. Xerostomia-Related Quality of Life Scale (XeQoLS)

    Time frame: 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.

  3. Xerostomia-Related Quality of Life Scale (XeQoLS)

    Time frame: 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.

  4. Oral Health Impact Profile-14 (OHIP-14)

    Time frame: 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.

  5. Oral Health Impact Profile-14 (OHIP-14)

    Time frame: 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.

  6. Oral Health Impact Profile-14 (OHIP-14)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sergio B Macedo, PhD

CONTACT

[email protected]

+5561981276050

Sponsors and collaborators

Lead sponsor

University of Brasilia

Other

Registry information

Official study title

The Effect of Ozone Therapy on Salivary Flow and Quality of Life in Patients With Xerostomia and Hyposalivation After Head and Neck Radiotherapy

Acronym: ozonexerostomi

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
May 6, 2026
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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