Sialendoscopy versus photobiomodulation to prevent radiation‑related dry mouth
Official title: Sialendoscopic Management Versus Photobiomodulation in Prevention of Radiation-induced Xerostomia in Head and Neck Cancer Patients (Randomized Clinical Trial)
Run by Alexandria University · NCT07476209 · Data updated 2026-11-12
This trial compares a minimally invasive duct‑clearing procedure (sialendoscopy) with a light‑based laser therapy (photobiomodulation) to try to prevent dry mouth in adults receiving radiation for head and neck cancer.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 42 (estimated) |
| Sponsor | Alexandria University Academic / other |
| Drugs / interventions | Radiation |
| Locations | 1 site (Alexandria) |
| Status | Recruiting |
| Started | April 1, 2026 |
| Main results expected | December 31, 2026 |
| Study ends | March 1, 2027 |
| Registry record updated | March 25, 2026 |
| Trial ID | NCT07476209 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) with head and neck cancer scheduled for IMRT as definitive or adjuvant therapy with planned bilateral parotid mean dose ≤25 Gy and without uncontrolled systemic disease or Sjögren's syndrome.
✕Probably not a fit
Patients with Sjögren's syndrome, uncontrolled systemic illness, recent use of xerostomia medications, or those receiving higher parotid radiation doses are unlikely to benefit from these preventive approaches.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized clinical trial will enroll 42 adults with head and neck cancer who are scheduled for IMRT with planned bilateral parotid mean dose ≤25 Gy. Participants are randomized to receive either sialendoscopy performed before the first radiotherapy session or a course of photobiomodulation, with treatments delivered at the Faculty of Dentistry, Alexandria University. Sialendoscopy aims to restore ductal patency and reduce inflammation to improve salivary flow, while photobiomodulation uses low‑level laser light to stimulate glandular cellular activity and blood flow. Outcomes include measures of xerostomia severity and salivary function over follow‑up to determine which approach better prevents radiation‑induced dry mouth.
Why it matters
Potential benefit: If successful, the intervention could reduce or prevent radiation‑induced dry mouth and improve oral health and quality of life for head and neck cancer patients.
How similar studies have gone: Small studies and case series have suggested that photobiomodulation can reduce xerostomia symptoms and that sialendoscopy can improve salivary flow, but direct randomized comparisons are limited and this head‑to‑head approach is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients who are going to receive (IMRT) as a treatment of (HNC) either as postoperative (adjuvant) therapy or definitive therapy. * Patients who are planned to receive (RT) with parotid mean dose bilaterally not exceeding 25 Gy. * Males and females with an age not less than 18 years30 Exclusion Criteria: * Patients suffering from uncontrolled systemic diseases (such as diabetes, hypertension, cardiovascular, liver or renal dysfunction). * Patients with history of using drugs such as (pilocarpine ), oral humidifiers or herbs that prevent or treat xerostomia 2 months prior to study inclusion. * Patients with findings of any physical or mental abnormality which would interfere with or be affected by the study procedure. * Patients diagnosed with Sjögren's disease or other underlying systemic illness that is known to cause xerostomia.
Where it's running
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Faculty of Dentistry, Alexandria University
Alexandria, Egypt Recruiting
Study contacts
- Study coordinator: Basma Morsy, MSc
- Email: basma.mohamed.dent@alexu.edu.eg
- Phone: +201018222678
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.