Skip to content

Comparison between virtually planned surgeries and conventional surgeries in patients requiring mandibular reconstruction undergoing free fibula flap cover

Comparison between CAD/CAM assisted and conventional fibular free flap surgery in patients requiring mandibular reconstruction: A single center randomized control trial - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/09/074526
Enrollment
30
Registered
2024-09-30
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: CAD/CAM group: Preoperative virtual surgical planning is done and 3D printed cutting guides are obtained. Both the resecting team and reconstruction team shall start the procedure simul

Sponsors

AIIMS Bhubaneswar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: � Patients aged 18 years and above. � Patients requiring mandibular resection for various benign and malignant conditions of oral cavity. � Planned reconstruction using either CAD/CAM assisted or conventional free fibular flap technique. � Willingness to comply with the study protocol, including follow-up visits and assessments. � Adequate medical fitness for surgery as assessed by the treating surgical team. � Availability of preoperative and postoperative imaging data for evaluation. � Willingness to participate in long-term follow-up assessments as required by the study protocol.

Exclusion criteria

Exclusion criteria: � Patients with distant metastasis of oral carcinoma. � Previous history of head and neck radiation therapy. � Patients with significant medical comorbidities that may increase the risk of surgical complications or affect long-term outcomes. � Inability to undergo either CAD/CAM assisted or conventional free fibular flap reconstruction due to anatomical or surgical contraindications. � Patients with peronea arteria magna. � Patients unwilling to undergo the required follow-up assessments as per the study protocol.

Design outcomes

Primary

MeasureTime frame
Functional outcomes- Mandible Occlusion Structural outcome- postoperative 3D CT Gonial angles, Inter gonial distance, Intercondylar distance and AP distance comparison with preoperative 3D CT Aesthetic outcome by comparison of preop and postoperative facial photographs on VASTimepoint: 1 week and 6 weeks following surgery

Secondary

MeasureTime frame
- To analyze and compare mean operative time, mean ischemia time between both groups. - To assess the early and late post operative complications such as flap congestion, need for re-operation, flap failure, fistula formation, plate extrusion, bleeding, and infection in both the groups.Timepoint: 0-3 months

Countries

India

Contacts

Public ContactSurya Yashaswi PVS

AIIMS Bhubaneswar

plastic_sanjay@aiimsbhubaneswar.edu.in9438884117

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026