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

NCT07306546 | Not Yet Recruiting

• 1 other identifier: KMUHIRB-F(II)-20250332
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Oral Squamous Cell Carcinoma (OSCC); Postoperative Pain; Postoperative Oral Mucositis; Free Flap Reconstruction; Oral Cancer

Keywords

Hydrogen water; Oral cancer; Free flap reconstruction; Pain assessment; Salivary Biomarkers

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline (T0) and Day 7 (T1)

• Oral Assessment Guide (OAG) Score

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

  Baseline (T0) and Day 7 (T1)

Study Arms (2)

Hydrogen Water Oral Care Group

EXPERIMENTAL

This study adopts a randomized controlled trial (RCT) design with an equal allocation pretest-posttest approach and double-blind methodology. Eligible patients who underwent microsurgical free flap reconstruction for oral cancer were enrolled once their postoperative condition stabilized. They were randomly assigned in a 1:1 ratio to the experimental group using a computer-generated randomization table. Immediately after allocation, the first saliva collection (T0) was performed. Participants in the experimental group received daily hydrogen water oral care, using hydrogen water with a concentration of 1.1 mg/L and a dissolution stability of at least 12 hours. A second saliva collection (T1) was conducted on Day 7 of the intervention to evaluate changes in salivary inflammatory biomarkers, oral microbiota, and pain.

Other: Hydrogen Water Oral Care

Water Oral Care Group

PLACEBO COMPARATOR

Patients assigned to the control group through the same computer-generated 1:1 randomization process received tap water oral care. The first saliva collection (T0) was completed immediately after group allocation. Participants in the control group performed oral care daily using tap water at time points and frequencies identical to those of the experimental group. The second saliva collection (T1) occurred on Day 7 of the intervention to compare the effects of different oral care solutions on changes in salivary inflammatory biomarkers, oral microbiota, and pain.

Other: Water Oral Care

Interventions

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.

Hydrogen Water Oral Care Group

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.

Water Oral Care Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Pain, Postoperative; Mouth Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Mouth Diseases; Stomatognathic Diseases

Study Officials

• I-SHAN CHOU, MS

  Kaohsiung Medical University Chung-Ho Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

I-SHAN CHOU, MS

CONTACT

+886-917-520-113; awoponn20@gmail.com

Pi-Ling Chou, PhD

CONTACT

886-7-3121101; piling.chou@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2025
• First Posted: December 29, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: December 29, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share