Oral Squamous Cell Carcinoma (OSCC)NCT07306546
Effectiveness of Hydrogen Water Intervention on Acute Oral Inflammation, Oral Microbiota, and Pain Following Free Flap Reconstruction in Patients With Oral Cancer
A study testing Hydrogen Water Oral Care and Water Oral Care in people with Oral Squamous Cell Carcinoma (OSCC) and Postoperative Pain, run by Kaohsiung Medical University Chung-Ho Memorial Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Squamous Cell Carcinoma (OSCC), Postoperative Pain, Postoperative Oral Mucositis
- What is being tested?
- Hydrogen Water Oral Care and Water Oral Care
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Jan 2026to 31 Oct 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the detailed description
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)
- Conditions
- Oral Squamous Cell Carcinoma (OSCC), Postoperative Pain, Postoperative Oral Mucositis, Free Flap Reconstruction, Oral Cancer
- Being tested
- Hydrogen Water Oral Care, Water Oral Care
- Keywords
- Hydrogen water, Oral cancer, Free flap reconstruction, Pain assessment, Salivary Biomarkers
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Pain, Postoperative, Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrogen Water Oral CareOther
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 CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Water Oral Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline (T0) and Day 7 (T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study startJan 2026 (estimated)
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Squamous Cell Carcinoma (OSCC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- I-SHAN CHOU, MS, Principal investigator, Kaohsiung Medical University Chung-Ho Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07306546
- Sponsor's protocol ID
- KMUHIRB-F(II)-20250332
- Status last verified
- Nov 2025
- First submitted
- 7 Dec 2025
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No