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

NCT07306546 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-12-29

No results posted yet for this study

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

Interventions

OTHER

Hydrogen Water Oral Care

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.

OTHER

Water Oral Care

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.

Sponsors & Collaborators

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    lead OTHER

Principal Investigators

  • I-SHAN CHOU, MS · Kaohsiung Medical University Chung-Ho Memorial Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-31
Primary Completion
2027-10-31
Completion
2027-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07306546 on ClinicalTrials.gov