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RECRUITING
NCT07306546
NA

Effectiveness of Hydrogen Water Intervention on Acute Oral Inflammation, Oral Microbiota, and Pain Following Free Flap Reconstruction in Patients With Oral Cancer

Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

View on ClinicalTrials.gov

Summary

This randomized, double-blind, parallel-group controlled trial evaluates the effectiveness of hydrogen water oral care on acute oral inflammation, oral microbiota, and pain in patients with oral cancer who have undergone free flap reconstruction. After postoperative transfer from the intensive care unit to the plastic surgery ward, eligible patients who provide written informed consent are randomly assigned in a 1:1 ratio to receive oral care with either hydrogen water or boiled drinking water for 7 days. Saliva samples and pain assessments are collected at baseline (T0), Day 3 (T1), and Day 7 (T2) of the intervention.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2025-12-16

Completion Date

2027-10-31

Last Updated

2026-10-27

Healthy Volunteers

No

Interventions

OTHER

Hydrogen Water Oral Care

Oral care is performed with a sterile sponge toothbrush dipped in hydrogen water (average concentration 1.1 mg/L), gently brushing the oral mucosa, the upper and lower jaws, and the tongue surface, avoiding mechanical irritation, for 7 days. The hydrogen water is prepared on site twice a day with a nano hydrogen water machine.

OTHER

Water Oral Care

Oral care is performed in the same manner and at the same frequency as the experimental group, with a sterile sponge toothbrush dipped in boiled water, gently brushing the oral mucosa, the upper and lower jaws, and the tongue surface, for 7 days. Only the liquid differs between the two groups.

Locations (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan