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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKaohsiung Medical University Chung-Ho Memorial Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Hydrogen Water Oral Care

    Other intervention

    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 intervention

    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.

Treatment groups

36 Participants
are divided into 2 treatment groups
Group A: Hydrogen Water Oral Care GroupExperimental treatment 1 intervention
Group B: Water Oral Care GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

IL-1β、IL-6、IL-10、TNF-α

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.

Time frame
Baseline (T0) and Day 7 (T1)
2

Oral Assessment Guide (OAG) Score

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

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

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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