Comparison and Assessment of Newly Designed Z Plate with 3D Plate for fixation of Lower Jaw Fractures.

Evaluation Of a Novel Design Z Plate With 3D Plate Semi Rigid Fixation for the Management of Mandibular Symphysis, Parasymphysis and Angle fracture- A Randomised Controlled Trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/06/025860

Enrollment

Registered

2020-06-14

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: Fixation of Mandibular Symphysis, Parasymphysis and Angle fracture of Mandible using Z plate: Under Local Anaesthesia , After detailed History, Consents, Fracture site will be exposed a

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients who are willing to participate in the study. 2. Patient with unfavourable symphysis, parasymphysis and angle fractures. 3. Patient with favourable fractures and willing for open reduction and internal fixation 4. Patients with no significant medical history.(ASA I and ASA II) 5. Patients with unilateral and/or bilateral fracture present on symphysis, parasymphysis and angle region of mandible.

Exclusion criteria

Exclusion criteria: 1. Patients not willing for participation in the study 2. Patients with severe systemic conditions.( ASA III And ASA IV) 3. Pregnant and lactating patient. 4. Patients with condylar/subcondylar/coronoid/ mid face fractures. 5. Patients presenting with severe comminuted fractures. 6. Patients with fractures presenting with severe soft tissue loss. 7. Patient not willing for open reduction. 8. Patients with craniomaxillofacial fractures.

Design outcomes

Primary

Measure	Time frame
1. To compare the duration of fracture fixation in Symphysis, Parasymphysis and angle region of mandible. 2. To check Paraesthesia of lower lip. 3. To compare the occlusal stability postoperatively.Timepoint: 1.Immediate 2.at 7th day,1month,3months,6months 3. At 7thday 1month,3months,6months	—

Secondary

Measure	Time frame
1.To compare for the lingual splaying postoperatively. 2. To study the cost effectiveness of both semi rigid fixation techniques. 3.To study any postoperative complicationsTimepoint: 1.preop and 3rd post op day 2.Immediate 3. 7thday,1st month,3 month,6 month	—

Countries

India

Contacts

Public ContactDr Suleka Ranganath

government dental college mumbai

prajwalitkende1979@gmail.com9324715824

Outcome results

None listed

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