Effectiveness of Hydrogen Water Intervention on Acute Oral Inflammation, Oral Microbiota, and Pai… (NCT07306546) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Effectiveness of Hydrogen Water Intervention on Acute Oral Inflammation, Oral Microbiota, and Pain Following Free Flap Reconstruction in Patients With Oral Cancer
36 participantsStarted 2026-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
IL-1β、IL-6、IL-10、TNF-α
Timeframe: Baseline (T0) and Day 7 (T1)
2
Oral Assessment Guide (OAG) Score
Timeframe: Baseline (T0) and Day 7 (T1)
Trial details
NCT IDNCT07306546
SponsorKaohsiung Medical University Chung-Ho Memorial Hospital