Computer Guided Lag Screw Fixation Versus Conventional Lag Screw Fixation in Anterior Mandibular Fractures

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03530891
• Date of registration: 04/05/2018
• Prospective Registration: No
• Primary sponsor: Cairo University
• Public title: Computer Guided Lag Screw Fixation Versus Conventional Lag Screw Fixation in Anterior Mandibular Fractures
• Scientific title: Evaluation of the Efficacy of Computer Guided Lag Screw Fixation in Comparison to Conventional Lag Screw Fixation in Anterior Mandibular Fractures (RCT)
• Date of first enrolment: January 11, 2018
• Target sample size: 26
• Recruitment status: Unknown status
• URL: https://clinicaltrials.gov/show/NCT03530891
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Egypt

Contacts

• Name: Mohamed N Kadry, MSc

• Name: Mohamed N Kadry, MsC

• Name: Khaled S Amr, PhD
• Affiliation: Faculty of oral and dental medicine, Cairo University.

Key inclusion & exclusion criteria

Inclusion criteria:

- Patients with anterior mandibular fracture indicated for open reduction internal
fixation alone or in combination with fracture elsewhere in the mandible or mid face.

- All ages and both sexes were included in this study.

- Patients should be free from any systemic disease that may affect normal healing of
bone, and predictable outcome.

- Patients with good general condition allowing major surgical procedure under general
anaesthesia .

- Patients with physical and psychological tolerance.

Exclusion criteria:

- Patients with comminuted fractures as it is not indicated for compression
osteosynthesis like lag screws.

- Patients with high risk systemic diseases like uncontrolled diabetes mellitus. As
uncontrolled diabetes mellitus has a negative impact on normal bone healing.

- Patients with old and/or mal-union fractures. As they will affect accuracy of
reduction of the fractured segments.



Age minimum: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Mandible Fracture

Intervention(s)

Procedure: Computer guided lag screw fixation

Procedure: Conventional lag screw fixation

Primary Outcome(s)

Stability of fixed fractured segment [Time Frame: 1st week post operative.]

Secondary Outcome(s)

neurosensory disturbance [Time Frame: one month post operative]

supplemental fixation devices [Time Frame: intra operative and one month post operative]

Accuracy of lag screw placement [Time Frame: 1st week post operative.]

Need for second surgery [Time Frame: one month post operative]

Secondary ID(s)

CEBD-CU-2018-5-4

Source(s) of Monetary Support

Please refer to primary and secondary sponsors