[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636874":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":24,"locations":18,"responsibleParty":30,"collaborators":18,"id":34,"slug":35,"hasResults":36,"nctId":37,"briefTitle":38,"officialTitle":39,"acronym":40,"eligibilityCriteria":41,"healthyVolunteers":36,"sex":42,"minAge":43,"maxAge":18,"enrollmentInfo":44,"targetDuration":18,"studyType":47,"phases":48,"briefSummary":50,"conditions":51,"keywords":53,"overallStatus":58,"whyStopped":18,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":18},{"fullName":5,"class":6},"University of Brasilia","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"ozone therapy","EXPERIMENTAL","Ozone gas will be applied as follows:\n\n* Parotid glands: two distinct points per gland, 1 mL at each point (10 µg\u002FmL). The anatomical reference will be the parotid region, located anterior and inferior to the external ear.\n* Submandibular glands: one point per gland, 1 mL at 10 µg\u002FmL. The anatomical reference will be the mandibular base, anterior to the angle, considering its inner aspect.\n* Sublingual glands: one point per gland, 1 mL at 10 µg\u002FmL. 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.\n\nThe ozone generator (Dental model, Philozon, Brazil) will be supplied with medical oxygen (99.5% purity).",[13],"Other: Ozone therapy",{"label":15,"type":16,"description":17,"interventionNames":18},"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",null,[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":18},"Ozone therapy","Experimental: Ozone Therapy\n\nOzone gas will be applied as follows:\n\n* Parotid glands: two distinct points per gland, 1 mL at each point (10 µg\u002FmL). The anatomical reference will be the parotid region, located anterior and inferior to the external ear.\n* Submandibular glands: one point per gland, 1 mL at 10 µg\u002FmL. The anatomical reference will be the mandibular base, anterior to the angle, considering its inner aspect.\n* Sublingual glands: one point per gland, 1 mL at 10 µg\u002FmL. 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.\n\nThe ozone generator (Dental model, Philozon, Brazil) will be supplied with medical oxygen (99.5% purity).",[9],[25],{"name":26,"role":27,"phone":28,"phoneExt":18,"email":29},"Sergio B Macedo, PhD","CONTACT","+5561981276050","bruzadelli@unb.br",{"type":31,"investigatorFullName":32,"investigatorTitle":33,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Sergio Bruzadelli Macedo","Clinical Professor","100636874","the-effect-of-ozone-on-salivary-flow-in-patients-with-xerostomia-and-hyposalivation-after-radiotherapy-ozonexerostomi-100636874",false,"NCT07571356","The Effect of Ozone on Salivary Flow in Patients With Xerostomia and Hyposalivation After Radiotherapy (OZONEXEROSTOMI)","The Effect of Ozone Therapy on Salivary Flow and Quality of Life in Patients With Xerostomia and Hyposalivation After Head and Neck Radiotherapy","ozonexerostomi","Inclusion Criteria:\n\n* Patients who have undergone head and neck radiotherapy\n* Patient who have developed xerostomia\n* Patient who have developed hyposalivation\n\nExclusion Criteria:\n\n* Patients with active malignant disease\n* Patients who do not agree to sign the informed consent form","ALL","18 Years",{"count":45,"type":46},100,"ESTIMATED","INTERVENTIONAL",[49],"NA","Patients who underwent head and neck radiotherapy and developed xerostomia and\u002For hyposalivation will be selected. The patients will be randomly assigned into two groups, defined as control and treatment.\n\nAll 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).\n\nThe quantitative assessment will be carried out through the collection of unstimulated and stimulated saliva at the same time points (T0, T6, and T12).\n\nPatients will undergo 12 sessions of ozone therapy, once a week, in gaseous form, at a concentration of 10 µg\u002FmL (micrograms per milliliter), applied directly into the major salivary glands.\n\nThe gas will be administered as follows:\n\n* Parotid glands: two distinct points per gland, 1 mL at each point.\n* Submandibular glands: one point per gland, 1 mL per point at 10 µg\u002FmL.\n* Sublingual glands: one point per gland, 1 mL per point at 10 µg\u002FmL. The ozone generator equipment will be supplied with medical oxygen (99.5% purity), Dental model, Philozon company.\n\nDisposable syringes will be Terumo, 10 mL, and the needle will be BD, 30\u002F13 mm.",[52],"Xerostomia Following Radiotherapy",[54,55,56,57],"xerostomia","ozone","hiposalivation","radio therapy","NOT_YET_RECRUITING","2026-05-04",{"date":61,"type":62},"2026-05-06","ACTUAL",{"date":64,"type":46},"2026-07-15",{"date":66,"type":46},"2028-01-15",{"name":5,"class":6}]