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Construction and validation of masticatory function rehabilitation program after functional mandibular reconstruction

Construction and validation of masticatory function rehabilitation program after functional mandibular reconstruction

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300078248
Enrollment
Unknown
Registered
2023-12-01
Start date
2023-12-01
Completion date
Unknown
Last updated
2023-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral and maxillofacial head and neck tumors

Interventions

Experimental group:Routine nursing + chewing rehabilitation intervention, 20 minutes three times a day
Control group:Routine nursing

Sponsors

Shanghai Ninth People's Hospital, Affiliated to Shanghai Jiaotong University, School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Aged 18-70 years; (2) Men and women are not limited; (3) mandibular benign tumors or lesions requiring mandibular amputation; (4) Normal blood routine, coagulation function, liver function, kidney function and ECG within 1 week before surgery (hemoglobin > 80 g/L; The absolute neutrophil count was > 1.5×109/L, and the platelet count was > 100 ×109/L. Bilirubin < 35 umol/L; AST or ALT < 3 x upper normal limit; Serum creatinine < 130 umol/L or creatinine clearance =50 ml/min); (5) Maxillofacial enhanced CT and panoramic film were performed 1 week before surgery; (6) No organic lesions of important organs, suitable for general anesthesia surgery; (7) Postoperative radiotherapy and chemotherapy were not required.

Exclusion criteria

Exclusion criteria: (1) Recurrence of other malignant tumors or primary tumors within five years; (2) Have a history of severe drug allergy; (3) pregnant, lactating or patients with neurological disorders; (4) Patients who have participated in other clinical trials; (5) Patients who have received anti-tumor therapy such as radiotherapy, chemotherapy and targeted drugs before surgery; (6) Mouth opening < 3.5cm; (7) contraindications associated with general anesthesia surgery (such as high blood pressure, diabetes, etc., which are difficult to control with drugs); (8) Patients with congenital immune deficiency or organ transplantation; (9) Patients with HBV, HCV, HIV, TRUST and other related diseases.

Design outcomes

Primary

MeasureTime frame
masticatory efficiency; visual analogue scale, VAS;

Secondary

MeasureTime frame
Bite force measurement;QLQH&N35;

Countries

China

Contacts

Public ContactGu Fen

Shanghai Ninth People's Hospital, Affiliated to Shanghai Jiaotong University, School of Medicine

gufen927@163.com+86 159 0212 4050

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026