JRCT ID: jRCT1022260005
Registered date:08/05/2026
Evaluation of the impact of temporalis muscle surgical manipulation on oral function in perioperative neurosurgical patients
Basic Information
| Recruitment status | Recruiting |
|---|---|
| Health condition(s) or Problem(s) studied | Patients undergoing neurosurgical surgery |
| Date of first enrollment | 08/05/2026 |
| Target sample size | 30 |
| Countries of recruitment | |
| Study type | Observational |
| Intervention(s) |
Outcome(s)
| Primary Outcome | Change in occlusal force over time |
|---|---|
| Secondary Outcome | 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) |
Key inclusion & exclusion criteria
| Age minimum | >= 18age old |
|---|---|
| Age maximum | Not applicable |
| Gender | Both |
| Include criteria | 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. |
| Exclude criteria | 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). |
Related Information
| Primary Sponsor | Fujii Masazumi |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | |
| Secondary ID(s) |
Contact
| Public contact | |
| Name | Yoshiyuki Oku |
| Address | 1 Hikarigaoka, Fukushima City, Fukushima 960-1295, Japan Hukushima Japan 960-1295 |
| Telephone | +81-24-547-1076 |
| oku37777@fmu.ac.jp | |
| Affiliation | Nutrition Management Department, Fukushima Medical University Hospital |
| Scientific contact | |
| Name | Masazumi Fujii |
| Address | 1 Hikarigaoka, Fukushima City, Fukushima 960-1295, Japan Hukushima Japan 960-1295 |
| Telephone | +81-24-547-1111 |
| fujiimasazumi@gmail.com | |
| Affiliation | Department of Neurosurgery, Fukushima Medical University |