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| Name | Class |
|---|---|
| Imam Khomeini Hospital | OTHER |
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The present study compared the efficacy of BioXtra spray and mouth rinse in the relief of radiotherapy-induced xerostomia in patients referred to Cancer Institute, Tehran Imam Khomeini Hospital.
Xerostomia or dry mouth is an important complication of radiotherapy for head and neck regions producing serious discomfort for patients with a significant reduction in their quality of life. Symptomatic treatments for the disease include maintain oral hygiene and use of artificial saliva substitutes.
Due to limited studies on efficacy compounds BioXtra, present study compared the effects of spray and mouth rinse BioXtra in symptoms of xerostomia in patients under head and neck cancer radiotherapy .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| bioxtra spray and mouth rinse | Other | Drug: BioXtra spray or mouth rinse Patients had been xerostomia due to radiation of head and neck were selected for the study. Gender, age, medical history, VAS, dichotomous questionnaire of xerostomia , and other treatment used for this disease were recorded. Local ethical committee approval was obtained before the trial started and all patients gave written informed consent. Patients were randomly divided into two groups .First group received BioXtra spray and second group used BioXtra mouth rinse for 2 weeks and then 1 weeks wash -out period and for other 2 weeks drugs is switched . Each patients was examined at the beginning of the therapy ,and then 2 weeks after therapy and 35 days after first visit. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bioxtra | Drug | spray /mouth rinse |
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| Measure | Description | Time Frame |
|---|---|---|
| improvement of xerostomia | change of symptoms of xerostomia is measured by Visual Analogue Scale and Dichotomos questionnaire[ Time Frame: baseline compared with measures on day 14](streamdown:incomplete-link) | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| comparative analysis of improvement xerostomia between 2 drugs | change of symptoms of xerostomia is measured by Visual Analogue Scale and Dichotomos questionnaire[ Time Frame: baseline compared with measures on day 35 and comparative analysis between BioXtra spray and mouth rinse](streamdown:incomplete-link) | 5 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mahin Bakhshi, DDS/MS | Qazvin University Of Medical Sciences | Study Chair |
| Touba Karagah, DDS | QUMS | Principal Investigator |
| Soheila Manifar, DDS/MS | Imam Khomeini Hospital | Study Director |
| Navid Mohamadi, PHD | QUMS | Study Director |
| Abbas Hosseinmardi, DDS | QUMS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qazvin University of Medical Sciences | Qazvin | Qazvin Province | 3415759811 | Iran |
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| ID | Term |
|---|---|
| D014987 | Xerostomia |
| ID | Term |
|---|---|
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| C460819 | BioXtra |
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