UMIN-ICDS Clinical Trial

Public title

Comparison of a novel oral dry-material removal gel with a conventional oral moisturizer in patients with dysphagia receiving non-oral nutrition

Acronym

Oral Dry-Material Gel Study

Scientific Title

Clinical evaluation of a novel oral dry-material removal gel compared with a conventional oral moisturizing gel

Scientific Title:Acronym

Macerate Gel Oral Care Study

Region

Japan

Condition

Oral dryness and desquamated epithelial membrane in patients with dysphagia receiving non-oral nutrition

Classification by specialty

Rehabilitation medicine	Dental medicine	Adult

Classification by malignancy

Others

Genomic information

NO

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

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable

Primary outcomes

Time to peelability of the desquamated epithelial membrane (seconds). Timing starts at the first application of the study product to the membrane and ends when continuous visual and tactile assessment confirms that the membrane edge has lifted from the mucosal surface and removal can be initiated without resistance. Time is measured in seconds using a stopwatch, three times daily on Days 1-4.

Key secondary outcomes

1.Desquamated epithelial membrane removal time (seconds): from the point at which peelability is confirmed until complete macroscopic removal of the membrane from the oral cavity.
2.Post-care tongue mucosal moisture: measured immediately after oral care and before the final application of the study product using the Murata Oral Moisture Checker Mucus (OC-100); the median of three consecutive measurements is used.
3.Inter-care tongue mucosal moisture: measured immediately before the next oral-care session for the morning-to-noon and noon-to-evening intervals; the median of three consecutive measurements is used.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Self control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Other

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.

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

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 sample size

30

Name of lead principal investigator

1st name	takao
Middle name
Last name	gemma

Organization

Sapporo Azabu Neurosurgical Hospital

Division name

Department of Rehabilitation

Zip code

0650022

Address

1-40, Kita 22-jo Higashi 1-chome, Higashi-ku, Sapporo, Hokkaido, Japan

TEL

0117312321

Email

sp2b6dk9@marble.ocn.ne.jp

Name of contact person

1st name	takao
Middle name
Last name	gemma

Organization

Sapporo Azabu Neurosurgical Hospital

Division name

Department of Rehabilitation

Zip code

0650022

Address

1-40, Kita 22-jo Higashi 1-chome, Higashi-ku, Sapporo, Hokkaido, Japan

TEL

0117312321

Homepage URL

Email

sp2b6dk9@marble.ocn.ne.jp

Institute

Sapporo Azabu Neurosurgical Hospital

Institute

Department

Personal name

Organization

FoodCare Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Sapporo Azabu Neurosurgical Hospital

Address

1-40, Kita 22-jo Higashi 1-chome, Higashi-ku, Sapporo, Hokkaido, Japan

Tel

0117312321

Email

sp2b6dk9@marble.ocn.ne.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

北海道

Institutions

Date of disclosure of the study information

2026

Year

09

Month

03

Day

URL releasing protocol

Protocol is not publicly available.

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

32

Results

Thirty-one patients were analyzed. Median time to peelability was 195.75 [IQR 171.86-236.73] s with Viva Gellet and 126.70 [117.14-141.53] s with Macerate Gel, and was significantly shorter with Macerate Gel (Wilcoxon signed-rank test, p<0.001). Removal time was also shorter, and post-care and inter-care tongue moisture values were higher with Macerate Gel.

Results date posted

2026

Year

09

Month

03

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Thirty-one patients were analyzed. Mean age was 81.0+/-12.1 years; 18 (58.1%) were male and 13 (41.9%) were female. Diagnoses were cerebral infarction (n=15), intracerebral hemorrhage (n=10), acute subdural hematoma (n=2), traumatic subarachnoid hemorrhage (n=2), and subarachnoid hemorrhage (n=2). Median time from onset to evaluation was 12.0 [IQR 9.5-17.5] days; Charlson Comorbidity Index was 6.0 [5.0-7.0]; FILS level 1 was observed in 27 patients and FILS level 2 in 4 patients.

Participant flow

Among 32 consecutive eligible patients during the study period, one patient died during the evaluation period and was excluded. The final analysis included 31 patients. There were no other exclusions and no missing outcome data.

Adverse events

No adverse events related to either study product, including bleeding, pain, oral mucosal injury, aspiration, or allergic reactions, were observed.

Outcome measures

Primary outcome: time to peelability was 195.75 [IQR 171.86-236.73] s with A and 126.70 [117.14-141.53] s with B; median within-participant difference (B-A) was -59.98 [-111.53 to -47.50] s; Wilcoxon p=9.31x10^-10; rank-biserial correlation=-1.00.

Secondary outcomes: removal time was 121.20 [112.78-130.79] s with A and 100.25 [84.96-113.62] s with B, p=0.0000502. Post-care tongue moisture was 9.82 [8.48-12.17] with A and 17.20 [13.32-18.90] with B, p=1.02x10^-7. Inter-care tongue moisture was 4.00 [1.59-6.20] with A and 8.08 [7.15-9.84] with B, p=0.0000341.

Plan to share IPD

No plan to share individual participant data

IPD sharing Plan description

There is no current plan to share de-identified individual participant data outside the study team.

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

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

The study was conducted according to a prespecified protocol after ethics approval; however, UMIN-CTR registration is retrospective, after participant enrollment and study completion. Ethics approval No. 2024-019, approved July 15, 2024. Oral informed consent was obtained from each participant or a proxy. Macerate Gel and Viva Gellet were provided by FoodCare Co., Ltd.; the company had no role in study design, data collection, analysis, interpretation, or manuscript preparation.

Registered date

2026

Year

09

Month

03

Day

Last modified on

2026

Year

09

Month

03

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071909