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Development and clinical research of new technology for functional mandibular reconstruction

Development and clinical research of new technology for functional mandibular reconstruction

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000035932
Enrollment
Unknown
Registered
2020-08-20
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-08-24

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

Conditions

Benign tumor or lesion of the mandible

Interventions

Case series:Osteotomy of mandible + Dental implant distractor combined with free fibular flap + Preparation tracheotomy

Sponsors

Shanghai Ninth People's Hospital, 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 to 70 years; 2. No restrictions on men or women; 3. Patients with benign tumor or lesion of the mandible requiring osteotomy of mandible; 4. Within 1 week before surgery, blood routine, coagulation function, liver function, renal function and ECG were normal (hemoglobin>80 g/L; absolute neutrophil count > 1.5 x 10^9/L, platelet > 100 x 10^9/L; bile red = 50 ml/min); 5. Maxillofacial enhanced CT and panoramic film were performed one week before surgery; 6. No organic lesions of important organs, suitable for general anesthesia; 7. Postoperative radiotherapy and chemotherapy are not required.

Exclusion criteria

Exclusion criteria: 1.Complicated with other malignant tumor or recurrence of or primary tumor within 5 years; 2. History of severe drug allergy; 3. Patients with pregnancy, lactation or neurological disorders; 4. Patients who have participated in other clinical trials; 5. Patients who have received radiotherapy, chemotherapy and targeted drugs and other anti-tumor treatments before surgery; 6. Mouth opening < 3.5cm; 7. Contraindications associated with general anesthesia surgery (such as hypertension, diabetes etc, which are difficult to control with drugs); 8. Patients with congenital immune deficiency or organ transplantation; 9. Patients with diseases related to HBV, HCV, HIV, TRUST, etc..

Design outcomes

Primary

MeasureTime frame
Bone healing;Degree of wound healing;Postoperative complications;Primary lesion condition;

Countries

China

Contacts

Public ContactChenping Zhang

Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine

zhang.chenping@hotmail.com+86 13601963045

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 30, 2026