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Evaluation of Customized Polyetheretherketone (Peek) Plate versus 3D Delta Titanium Plate for the Internal Fixation of Mandibular Subcondylar Fractures - A Clinical Study

Comparative Evaluation of Efficacy of CAD-CAM Assisted Patient Specific Polyetheretherketone (Peek) Plate with 3D Delta Titanium Plate for the Fixation of Mandibular Subcondylar Fractures - A Prospective Randomized Controlled Trial - Polyetheretherketone (PEEK)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/01/030845
Enrollment
30
Registered
2021-01-29
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: M96- Intraoperative and postproceduralcomplications and disorders of musculoskeletal system, not elsewhere classified

Interventions

Intervention1: CAD-CAM assisted customized patient specific PEEK plates for fractured mandibular condyle: The CAD-CAM assisted Customized PEEK plate will be used for the open reduction and internal fi

Sponsors

Datta Meghe Institute of Medical Sciences Deemed to be University
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Cases of unilateral mandibular subcondylar fractures (mostly associated with symphysis / parasymphysis fracture). Patients should be free from any systemic disease that may affect normal healing of bone, and predictable outcome. Systemically healthy patients with ASA I/II grades. Patients with good general condition allowing major surgical procedure under general anaesthesia.

Exclusion criteria

Exclusion criteria: Patients with trifocal fractures in mandible will be excluded from the study. Patients with old fractures as they might affect accuracy of reduction of the fractured segments. Patient with comminuted fracture in condylar region Patients with bone loss or soft tissue loss at fracture site Endocrinopathies affecting calcium metabolism, chronic smokers, post menopausal women. Patients with mixed dentition and edentulous lower arch Evidence of infections at fracture site (diagnosed clinically, not with culture) Epileptic patients Medically compromised patients not fit for surgery. Patient not willing for surgical treatment.

Design outcomes

Primary

MeasureTime frame
The CAD-CAM assisted customized PEEK plate may be more effective in achieving the goals of fixation of mandibular subcondylar fractures as compared to the 3D Delta Titanium platesTimepoint: Postoperatively 1st Week, 4th week and 12th week—

Secondary

MeasureTime frame
The CAD-CAM assisted customised PEEK plate may be more effective in achieving the goals of fixation of mandibular subcondylar fractures as compared to the 3D Delta Titanium plates.Timepoint: Postoperatively 1st week, 4th week and 12th week—

Countries

India

Contacts

Public ContactAbhishek Wankhade

Datta Meghe Institute of Medical Sciences Deemed to be University

drnitinbhola@gmail.com9970070607

Outcome results

None listed

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