An interventional study of Hydrogen Water Oral Care and Water Oral Care in Oral Squamous Cell Carcinoma (OSCC), Postoperative Pain and Postoperative Oral Mucositis, sponsored by Kaohsiung Medical University Chung-Ho Memorial Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-29.
Sponsored by Kaohsiung Medical University Chung-Ho Memorial Hospital · Not applicable, Interventional, and Treatment
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.
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)
1,680 studies on the registry are indexed under Squamous Cell Carcinoma of Head and Neck; 539 are open to participants now.
This study's planned enrollment of 36 is below the median of 49 across 1,432 interventional studies indexed under Squamous Cell Carcinoma of Head and Neck.
Browse Squamous Cell Carcinoma of Head and Neck studies →Kaohsiung Medical University Chung-Ho Memorial Hospital is the lead sponsor of 281 studies on the registry; 57 are open to participants now.
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Exclusion Criteria:
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
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
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.
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.
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)
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)
No study locations are listed for this record.
Plan to share: No
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Kaohsiung Medical University Chung-Ho Memorial Hospital