Comparison of two different treatment methods in fracture of lower jaw using computerized splint and conventional metal arch bar.

Comparative Evaluation of Clinical Outcomes of CAD/CAM Splint and Conventional Arch Bar as an Adjunct to Open Reduction and Internal Fixation of Mandibular Fractures in Dentate Segment : A Prospective Randomized Control Study.

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/09/045607

Enrollment

Registered

2022-09-16

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

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: Open reduction and internal fixation using CAD CAM Splint as an adjunct for the management Mandibular Fractures: 3D Printed CAD CAM splint will be used to help in reduction of Mandibula

Eligibility

Inclusion criteria

Inclusion criteria: 1. Participants in the age group of 18 to 60 years. 2. Participants with monofocal, bifocal, trifocal Mandibular fractures of dentate segment (Symphysis Parasymphysis, Body and Angle regions). 3. Participants who have sustained fracture in the past two weeks. 4. Participants with 3 teeth on either side of fracture line (In cases with angle fractures 3 teeth in segment proximal to the fracture). 5. Participants willing to participate in the study.

Exclusion criteria

Exclusion criteria: 1. Participants with fractures of Mandibular ramus and condyle of Mandible. 2. Participants with fracture of edentulous Mandibular arches. 3. Participants with concomitant Midface fractures involving the dentition. 4. Participants with gross comminution of fracture segments. 5. Participants with history of metabolic bone disorders.

Design outcomes

Primary

Measure	Time frame
To compare clinical outcomes of CAD/CAM splint and conventional arch bar when used as an adjunct to Open Reduction and Internal Fixation in Mandible Fractures.Timepoint: Post op day 1, day 3 and 1 week	—

Secondary

Measure	Time frame
To evaluate and compare the radiographical outcomes of CAD/CAM splint and conventional arch bar as an adjunct to Open Reduction and Internal Fixation in patients with Mandibular Fractures in dentate segmentTimepoint: Preoperative evaluation 24 hours before surgery Postoperative evaluation at 24 hours and 6 weeks;To evaluate and compare the time taken for Open Reduction and Internal Fixation in patients with Mandibular fractures in dentate segment between the use of CAD/CAM splint and conventional arch bar as an adjunct.Timepoint: Time taken from exposure of fracture site till the last screw is drilled	—

Measure

Time frame

To evaluate and compare the radiographical outcomes of CAD/CAM splint and conventional arch bar as an adjunct to Open Reduction and Internal Fixation in patients with Mandibular Fractures in dentate segmentTimepoint: Preoperative evaluation 24 hours before surgery Postoperative evaluation at 24 hours and 6 weeks;To evaluate and compare the time taken for Open Reduction and Internal Fixation in patients with Mandibular fractures in dentate segment between the use of CAD/CAM splint and conventional arch bar as an adjunct.Timepoint: Time taken from exposure of fracture site till the last screw is drilled

—

Countries

India

Contacts

Public ContactSrivalli Natarajan

MGM Dental College & Hospital Navi Mumbai

srivalli.shrikanth@gmail.com9769088803

Outcome results

None listed

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