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A lab and clinical Testing of new plating system for jaw bone fracture

EFFICACY OF NOVEL UNI-PLATING SYSTEM FOR SYMPHYSIS FRACTURE BASED ON CHAMPY S LINE OF OSTEOSYNTHESIS : AN IN VITRO AND IN VIVO STUDY

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/03/082842
Enrollment
13
Registered
2025-03-19
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Health Condition 1: S026- Fracture of mandible

Interventions

Intervention1: uni-plating system for mandibular symphysis fracture: uni-plate is 6 hole 2.0mm titanium plate based on champys line of osteosynthesis Control Intervention1: not applicable: not applica

Sponsors

Dr Chinta Chetana Hota
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Fractures in the symphysis region of the mandible, which may be simple or compound or comminuted fractures Fractures suitable for treatment through an intra-oral approach and extra oral approach for pre-existing laceration. Individuals approved for surgery by a physician according to ASA classification. Patients willing to actively participate in clinical and radiological follow-up throughout the study period.

Exclusion criteria

Exclusion criteria: Patients unwilling for receiving treatment. Patients presenting with cysts and tumors.

Design outcomes

Primary

MeasureTime frame
Post-operative stability of the plating system.Timepoint: 24 hours, 7 days, 3 months and 6 months post-operative visits.

Secondary

MeasureTime frame
achievement of occlusal stability Timepoint: 24 hours, 7 days, 3 months and 6 months post-operative visits.

Countries

India

Contacts

Public ContactDr Mahesh Kumar R

Sri Siddhartha Dental College

mahu017@gmail.com9845417365

Outcome results

None listed

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