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Japanese

May. 08, 2026

May. 08, 2026

jRCT1022260005

An exploratory study evaluating the impact of temporalis muscle surgical manipulation on oral function in perioperative neurosurgical patients (TEMP-ORAL Study)

Evaluation of the impact of temporalis muscle surgical manipulation on oral function in perioperative neurosurgical patients (TEMP-ORAL Study)

Fujii Masazumi

Department of Neurosurgery, Fukushima Medical University

1 Hikarigaoka, Fukushima City, Fukushima 960-1295, Japan

+81-24-547-1111

fujiimasazumi@gmail.com

Oku Yoshiyuki

Nutrition Management Department, Fukushima Medical University Hospital

1 Hikarigaoka, Fukushima City, Fukushima 960-1295, Japan

+81-24-547-1076

oku37777@fmu.ac.jp

Recruiting

May. 08, 2026

30

Observational

randomized controlled trial

open(masking not used)

uncontrolled control

parallel assignment

other

1. Adult patients aged 18 years or older.
2. Patients scheduled to undergo neurosurgical surgery at Fukushima Medical University Hospital or Japanese Red Cross Fukushima Hospital after April 2026.
3. Patients able to provide written informed consent before surgery.

1. Patients with a history of disease or trauma affecting the oral and maxillofacial region.
2. Patients with dysphagia or swallowing disorders.
3. Patients with cognitive impairment that interferes with study assessments.
4. Patients with diseases causing severe restrictions in nutritional intake (e.g., gastrointestinal obstruction).
5. Patients unable to undergo MRI examination (e.g., pacemaker implantation).
6. Patients considered difficult to follow up (e.g., transfer to another hospital).

18age 0month 0week old over
No limit

Both

Patients undergoing neurosurgical surgery

Neurosurgical surgery

Neurosurgical Procedures [E04.730]

Change in occlusal force over time

1. Temporal muscle thickness changes
2. Oral hygiene status
3. Mouth opening
4. Masticatory function
5. FOIS score
6. Blood biochemical parameters
7. Body weight and BMI changes
8. Food intake
9. Clinical outcomes (surgery, complications, hospital stay)

Fukushima Medical University
Certified Review Board of Fukushima Medical University
1 Hikarigaoka, Fukushima City, Fukushima 960-1295, Japan, Fukushima

+81-24-547-1825

fmucrb@fmu.ac.jp
Approval

April. 21, 2026

No

none