Digital technology assisted the study of precise and minimally invasive reconstruction of mandible through intraoral approach

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100041768

Enrollment

Unknown

Registered

2021-01-05

Start date

2021-01-06

Completion date

Unknown

Last updated

2025-08-18

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

Conditions

Mandibular disease

Interventions

Intervention Group:Digital technology assisted the study of precise and minimally invasive reconstruction of mandible through intraoral approach

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Suffering with enign or borderline tumors of the mandible who have been diagnozed by Preoperative imaging assessment or pathological diagnosis and need to undergo jaw reconstruction; 2. Aged 18-60 years, regardless of gender (except for pregnant or expectant mothers); 3. Preoperative imaging evaluation or pathological diagnosis; 4. Voluntarily participating in this clinical trial and signing the informed consent; 5. Good compliance, willing and able to conduct follow-up observation as required.

Exclusion criteria

Exclusion criteria: 1. Uncontroled severe systemic diseases, including heart disease, hypertension, diabetes mellitus, hepatic and renal insufficiency, stroke, peripheral vascular diseases diagnosed by angiography and rheumatic immune diseases; 2. Participants with local intraoperative pathological diagnosis of malignant tumor requiring cervical lymph node dissection; 3. Participants with malignant tumors in other parts of the body; 4. Participants with calf trauma or vascular disease in whom fibula musculocutaneous flap cannot be used for repair; 5. illicit drug use or chronic alcohol abuse or total daily alcohol intake of > 50 g/ day; 6. Immunodeficiency or HIV positive; 7. Those who participated in any drug trial and did not reach the time limit of the main study endpoint before the start of this study; 8. Participants or their authorizers are unwilling to sign written informed consent or to comply with the study plan; 9. Participants can't follow-up on time as required; 10. Persons with mental illness or mental disorder; 11. Other conditions considered inappropriate by the researcher.

Design outcomes

Primary

Measure	Time frame
POSAS scar Scale;	—

Secondary

Measure	Time frame
Depression scale score;Anxiety scale score;Hospitalization expenses;The satisfaction of patients;Quality of Life Table score;Degree of jaw fitting;The pain level;Maxillofacial function;	—

Countries

China

Contacts

Public ContactChengzhe Yang

Qilu Hospital of Shandong University

yangchengzhe19@163.com+86 185 6008 5061

Outcome results

None listed

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