Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07476209

Sialendoscopy Versus Photobiomodulation in Prevention of Radiation Induced Xerostomia

Led by Alexandria University · Updated on 2026-03-25

42

Participants Needed

1

Research Sites

47 weeks

Total Duration

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AI-Summary

What this Trial Is About

Radiation induced xerostomia (RIX) represents a common debilitating side effect for (RT), adversely affecting oral health and hindering head and neck cancer (HNC) patients' quality of life (QOL). To date, managing (RIX) is mainly symptomatic, while the only FDA-approved preventive therapeutic agent is Amifostine, with associated systemic toxicities. Sialendoscopic management is a minimally invasive technique that can help in restoring ductal patency, decreasing inflammation and improving salivary flow. Laser Photobiomodulation (PBM) is a noninvasive approach that enhances salivary gland function by stimulating cellular activity, increasing blood flow and attenuating oxidative stress. Aim: The present study aims to evaluate and compare the efficacy of sialendoscopic management and photobiomodulation in managing (RIX) in (HNC) patients. Materials and Methods: A randomized clinical trial will be carried out on 42 (HNC) patients. Directly prior to the first (RT) session, Group I (n= 14 patients) will receive sialendoscopic management. Group II (n=14 patients) will receive (PBM) sessions. Group III (n= 14 patients) will receive basic oral care (BOC). Xerostomia will be evaluated at baseline, at 3 weeks and after 8 weeks from the end of (RT), clinically using Common Terminology Criteria for Adverse Events (CTCAE) v5.0 and objectively using unstimulated salivary flow. Quality of life will be assessed using Multidisciplinary Salivary Gland Society (MSGS) questionnaire. Salivary amylase will be assessed at baseline and after 8 weeks from the end of (RT).

CONDITIONS

Official Title

Sialendoscopy Versus Photobiomodulation in Prevention of Radiation Induced Xerostomia

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients planning to receive intensity-modulated radiation therapy (IMRT) for head and neck cancer as postoperative or definitive therapy
  • Radiation therapy planned with parotid mean dose bilaterally not exceeding 25 Gy
  • Male and female patients aged 18 years or older
Not Eligible

You will not qualify if you...

  • Uncontrolled systemic diseases such as diabetes, hypertension, cardiovascular, liver, or kidney dysfunction
  • Use of drugs like pilocarpine, oral humidifiers, or herbs for xerostomia prevention or treatment within 2 months prior to study
  • Physical or mental abnormalities interfering with study procedures
  • Diagnosis of Sj�f6gren's disease or other systemic illnesses known to cause xerostomia

AI-Screening

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Trial Site Locations

Total: 1 location

1

Faculty of Dentistry, Alexandria University

Alexandria, Egypt

Actively Recruiting

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Research Team

B

Basma Morsy, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

3

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