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Not yet recruiting NCT07571356

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

No phase Interventional Xerostomia Following Radiotherapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ozone therapy.
Who it may be relevant to
Registry conditions: Xerostomia Following Radiotherapy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Other Ozone therapy
    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 ref

Primary outcome measures

  • Salivary flow [Time frame: Time 0 weeks]
  • Salivary flow [Time frame: time 6 weeks]
  • Salivary Flow [Time frame: 12 week]
  • Salivary flow [Time frame: Time 0 weeks]
  • Salivary flow [Time frame: Time 6 weeks]
  • Salivary flow [Time frame: Time 12 weeks]
Secondary outcome measures (6)
  • Xerostomia-Related Quality of Life Scale (XeQoLS) [Time frame: time 0 weeks]
  • Xerostomia-Related Quality of Life Scale (XeQoLS) [Time frame: time 6 weeks]
  • Xerostomia-Related Quality of Life Scale (XeQoLS) [Time frame: time 12 weeks]
  • Oral Health Impact Profile-14 (OHIP-14) [Time frame: time 0 weeks]
  • Oral Health Impact Profile-14 (OHIP-14) [Time frame: time 6 weeks]
  • Oral Health Impact Profile-14 (OHIP-14) [Time frame: time 12 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07571356 · 66681722.6.0000.0030

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗