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

NCT07571356 | Not Yet Recruiting DMC

• 1 other identifier: 66681722.6.0000.0030
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Xerostomia Following Radiotherapy

Keywords

xerostomia; ozone; hiposalivation; radio therapy

Outcome Measures

Primary Outcomes (6)

• 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 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 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.

  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 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 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 12 weeks

Secondary Outcomes (6)

• 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

Study Arms (2)

ozone therapy

EXPERIMENTAL

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

no treatment

NO INTERVENTION

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

Interventions

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).

ozone therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who have undergone head and neck radiotherapy
• Patient who have developed xerostomia
• Patient who have developed hyposalivation

You may not qualify if:

• Patients with active malignant disease
• Patients who do not agree to sign the informed consent form

Sponsors & Collaborators

• University of Brasilia: lead

MeSH Terms

Conditions

Xerostomia

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Sergio B Macedo, PhD

CONTACT

+5561981276050; bruzadelli@unb.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: April 27, 2026
• First Posted: May 6, 2026
• Study Start (Estimated): July 15, 2026
• Primary Completion (Estimated): July 15, 2027
• Study Completion (Estimated): January 15, 2028
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL