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NCT Number: NCT07306546

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

This study employs a Randomized Controlled Trial (RCT) design. Patients diagnosed with oral cancer by the attending physician and who meet the inclusion criteria will be admitted to the study after receiving a full explanation of the study objectives, intervention methods, potential risks, and participant rights from the research team upon their stable transfer to the plastic surgery ward post-operation. Written consent will be obtained from the patient and/or their legally authorized representative after adequate informed consent has been provided, before they are enrolled in the study.

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Key information

About this study

The study adopts a Randomized Controlled Trial (RCT) design. Patients diagnosed with oral cancer by the attending physician and who meet the inclusion criteria are enrolled in the study upon their stable transfer from the Intensive Care Unit (ICU) to the plastic surgery ward post-operation.

The research team will personally explain the study objectives, intervention methods, potential risks, and participant rights to the subjects (and/or their legally authorized representatives) and provide written documentation. After addressing all questions, informed consent is obtained, and the subject is enrolled in the study.

Subjects are then assigned via computer-generated randomization at a 1:1 ratio. The experimental group (18 individuals) receives hydrogen-rich water oral care. The hydrogen-rich water is delivered daily after its concentration is measured.

Oral integrity is assessed using the Oral Assessment Guide (OAG), which includes 6 items: lips, tongue, saliva, oral mucosa, gums, and teeth, scored from 1 to 3 points. The minimum score is 6, and the maximum score is 18.

Oral care frequency is based on the OAG score:

6-10 points: Oral care once per shift. 11-14 points: Oral care once every 4 hours. 15-18 points: Oral care once every 2 hours. Oral care involves using a sponge toothbrush dipped in hydrogen-rich water (concentration 1.1 mg/L) to gently brush the mucosa, maxilla/mandible (upper/lower jaws), and tongue. This is continuously performed for 7 days.

The control group (18 individuals) receives plain boiled water for oral care, with the same frequency as the experimental group. The research team will daily record the subjects' compliance and any adverse reactions.

During the intervention period, both groups receive identical postoperative care and health education in the plastic surgery ward.

The research team will collect the first sample (pre-test, T0) when the patient is transferred from the ICU to the plastic surgery ward, and the second sample on the 7th day post-operation (T1). Saliva samples will be collected at both time points to evaluate oral inflammatory markers (such as IL-1$\\beta$, IL-6, IL-10, TNF-α) and the oral microbiome (analyzed by RT-PCR detection of the 16S rRNA gene sequence)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed with oral cancer and receiving microsurgical free flap reconstruction.
  • Age 18 years or older.
  • Conscious and able to follow study instructions.
  • Able to communicate without difficulty in Mandarin, Taiwanese, or through written communication.

Exclusion criteria

  • Abnormal salivary gland function or severe xerostomia.
  • Recent use of antibacterial mouthwash or antibiotic therapy that may affect oral microbiota.
  • Presence of severe bacterial or viral oral infections, or significant periodontal disease.

Treatment and study plan

Hydrogen Water Oral Care

Other

The research team provided hydrogen water daily according to group assignment. The hydrogen water used in this study contained 1.1 mg/L of dissolved hydrogen with a stability of no less than 12 hours. Participants performed oral care using the hydrogen water following standardized instructions. Saliva samples were collected at T0 (immediately after randomization) and T1 (Day 7 of the intervention) to assess changes in inflammatory markers, oral microbial composition, and pain levels during the intervention period.

Water Oral Care

Other

The research team provided tap water for oral care daily, following the same procedures, frequency, and schedule as the experimental group, but without the active hydrogen component. Saliva samples were collected at T0 (immediately after randomization) and T1 (Day 7 of the intervention) to establish a placebo-controlled comparison of outcomes related to inflammatory markers, microbial profiles, and pain.

Primary outcomes

  1. IL-1β、IL-6、IL-10、TNF-α

    Time frame: Baseline (T0) and Day 7 (T1)

    Salivary IL-1β、IL-6、IL-10、TNF-α concentration will be measured to assess the anti-inflammatory effect of hydrogen water oral care in postoperative oral cancer patients. Measurements will be used to evaluate changes in inflammation between baseline and Day 7.

  2. Oral Assessment Guide (OAG) Score

    Time frame: Baseline (T0) and Day 7 (T1)

    Change in total OAG score from baseline to Day 7 will be used to evaluate oral mucosal integrity.

Study contacts

Contact information is provided by the study sponsor or research team.

I-SHAN CHOU, MS

CONTACT

[email protected]

+886-917-520-113

Pi-Ling Chou, PhD

CONTACT

[email protected]

886-7-3121101 ext. 2610

Sponsors and collaborators

Lead sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 29, 2025
Registry last updated
Dec 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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