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Sialendoscopic Management Versus Photobiomodulation in Prevention of Radiation-induced Xerostomia in Head and Neck Cancer Patients (Randomized Clinical Trial)

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Egypt
Faculty of Dentistry, Alexandria University
RECRUITING
Alexandria
Contact Information
Primary
Basma Morsy, MSc
basma.mohamed.dent@alexu.edu.eg
+201018222678
Time Frame
Start Date: 2026-04-01
Estimated Completion Date: 2027-03-01
Participants
Target number of participants: 42
Treatments
Experimental: Group I: Sialendoscopy
Patients in this group will receive sialendoscopic management using an all-in-one 1.3-mm Marchal sialendoscope.
Active_comparator: Group II: Photobiomodulation
Patients in this group will receive laser photobiomodulation sessions (twice/week) for 6 weeks (total of 12 sessions)
No_intervention: Group III: Control
patients in this group will receive Basic oral care only
Related Therapeutic Areas
Sponsors
Leads: Alexandria University

This content was sourced from clinicaltrials.gov