Tokyo, Sept. 5 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062816) titled 'Comparison of a novel oral dry-material removal gel with a conventional oral moisturizer in patients with dysphagia receiving non-oral nutrition' on Sept. 3.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Self control

Primary Sponsor: Institute - Sapporo Azabu Neurosurgical Hospital

Condition: Condition - Oral dryness and desquamated epithelial membrane in patients with dysphagia receiving non-oral nutrition Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To compare the clinical effects of oral care using the novel oral dry-material removal agent Macerate Gel with those of the conventional oral moisturizing gel Viva Gellet in patients with dysphagia receiving non-oral nutrition and presenting with dry desquamated epithelial membrane, focusing on time to peelability, removal time, and tongue mucosal moisture. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - All participants received the same fixed intervention sequence. On Day 0, neither study product (Viva Gellet or Macerate Gel) was used; routine oral care was performed using Peptisal Gentle Mouth Gel and Peptisal Gentle Mouthwash. The final Day 0 care was performed at approximately 16:00, and the first intervention began approximately 18 hours later at around 10:00 on Day 1. The sequence was Day 1: A (Viva Gellet), Day 2: B (Macerate Gel), Day 3: B, and Day 4: A. Oral care was performed three times daily: morning 09:40-10:20, noon 13:20-14:00, and evening 15:40-16:20. A 0.5-g dose was used at the start of each oral-care session and another 0.5 g was applied after completion. No additional product was applied during care. All procedures and assessments were performed by the same speech-language-hearing therapist.

Eligibility: Age-lower limit - Not applicable Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1.Consecutive patients admitted to Sapporo Azabu Neurosurgical Hospital between October 2024 and September 2025. 2.Patients diagnosed with dysphagia by the attending physician. 3.FILS level 1 or 2 at study entry, with no oral intake for nutritional purposes. 4.MWST and Food Test performed in all patients; RSST performed when feasible except in patients with impaired consciousness or difficulty understanding instructions; patients judged unable to take nutrition orally based on swallowing assessment. 5.Presence of dry desquamated epithelial membrane in the oral cavity. 6.Oral informed consent obtained from the participant or a proxy. Key exclusion criteria - Patients unable to complete the planned 4-day evaluation protocol (e.g., death during the evaluation period). Target Size - 30

Recruitment Status: Recruitment status - Completed Date of protocol fixation - 2024 Year 09 Month 15 Day Date of IRB - 2024 Year 07 Month 15 Day Anticipated trial start date - 2024 Year 10 Month 07 Day Last follow-up date - 2025 Year 09 Month 26 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071909

Disclaimer: Curated by HT Syndication.