Clinical trial · Interventional
Effectiveness of Hydrogen Water Intervention on Acute Oral Inflammation, Oral Microbiota, and Pain Following Free Flap Reconstruction in Patients With Oral Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Free Flap Reconstruction | — | UNRESOLVED | — |
| Oral Cancer | Malignant Lip and Oral Cavity Neoplasm | CURATED_BROADER | 0.80 |
| Oral Squamous Cell Carcinoma (OSCC) | Oral Cavity Squamous Cell Carcinoma | ALIAS | 0.85 |
| Postoperative Oral Mucositis | — | UNRESOLVED | — |
| Postoperative Pain | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hydrogen Water Oral Care | Other | — | UNRESOLVED |
| Water Oral Care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Hydrogen Water Oral Care Group
- description
- 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.
- interventionNames
- Other: Hydrogen Water Oral Care
- type
- PLACEBO_COMPARATOR
- label
- Water Oral Care Group
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available