A prospective, randomized controlled study on improving the accuracy of mandibular angle osteotomy by human-machine craniofacial surgery robot based on artificial intelligence preoperative planning

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000036746

Enrollment

Unknown

Registered

2020-08-25

Start date

2020-09-01

Completion date

Unknown

Last updated

2020-09-21

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

Conditions

mandibular angle hypertrophy

Interventions

Experiment group:Robot-assisted surgery

Controlled group:The traditional surgery

Eligibility

Sex/Gender

All

Age

18 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. Mandibular angle operation (MAO); 2. Aged 18-50 years; No gender limitation; 3. Informed consented.

Exclusion criteria

Exclusion criteria: 1. Participate in any other clinical trial within 30 days prior to the start of the screening period; 2. Previous surgical history of the relevant site; 3. Patients undergoing complex repair surgery; 4. Patients with other cranial-maxillofacial syndrome; 5. Other conditions that lead to contraindications to general anesthesia (e.g., pregnancy or lactation; 6. A history of epilepsy or mental illness; 7. Severe cardiovascular and cerebrovascular diseases with cardiac function level III-IV and pulmonary function insufficiency, unable to tolerate the operation; 8. Liver cirrhosis, renal failure and other severe liver and kidney dysfunction; 9. Patients with systemic bleeding tendency and coagulation dysfunction; 10. Hepatitis and AIDS patients in active stage; 11. Uncorrected diabetic patients (random blood glucose > 11.1mmol/ L) and hypertensive patients (> 160/100mm hg).

Design outcomes

Primary

Measure	Time frame
Surgical precision;	—

Secondary

Measure	Time frame
Surgical curative effect(Including Relevant anatomical measurement data of osteotomy and mandible);Perioperative indicators (Blood loss, operation time, equipment installation time, drainage tube prevention time, drainage volume, hospital stay and other indicators);Subjective satisfaction table;Psychological Assessment Scale (International Pain Assessment Scale, HADS Hospital Anxiety and Depression Scale, SF-36 Quality of Life Questionnaire, Event Impact Scale);	—

Measure

Time frame

Surgical curative effect(Including Relevant anatomical measurement data of osteotomy and mandible);Perioperative indicators (Blood loss, operation time, equipment installation time, drainage tube prevention time, drainage volume, hospital stay and other indicators);Subjective satisfaction table;Psychological Assessment Scale (International Pain Assessment Scale, HADS Hospital Anxiety and Depression Scale, SF-36 Quality of Life Questionnaire, Event Impact Scale);

—

Countries

China

Contacts

Public ContactGang Chai

Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine

13918218178@163.com+86 13918218178

Outcome results

None listed

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