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"Evaluating Treatment outcomes in Lower Jaw Fractures at two sites with Mixed (combination of stiff and flexible) versus flexible fixation

Evaluation of treatment outcomes in double mandibular fracture management with mixed versus non-rigid fixation A randomized controlled trial. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/04/084497
Enrollment
28
Registered
2025-04-09
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-28

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: Group 1: Patients in this group will receive rigid fixation at one fracture site and non-rigid fixation at the other. (Mixed fixation): 1) Rigid Fixation - Defined as a method that prev

Sponsors

DrPavithraM
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Patients with double mandibular fractures (ipsilateral or contralateral) 2) Patients with permanent dentition and a sufficient number of teeth to evaluate occlusion. 3) Patients or their guardians who are willing to provide written informed consent for the surgical procedure and follow-up.

Exclusion criteria

Exclusion criteria: 1) Comminuted mandibular fractures. 2) Fractures associated with active infection, non-union, malunion 3) Patients with ASA IV / Immunocompromised patients 4) Patients with bone and metabolic disorders

Design outcomes

Primary

MeasureTime frame
To compare the treatment outcomes of mixed fixation (Group-1) versus non-rigid fixation (Group-2) in patients with double mandibular fractures by evaluating preoperative and postoperative bite force, occlusal alignment, hardware integrity, and wound healing status.Timepoint: Bite force, occlusal alignment, hardware integrity, wound healing status - a day before surgery, after surgery day-1, after 6 weeks and 3 months

Secondary

MeasureTime frame
Secondary Objectives: To assess the radiographic alignment of fractures following fixation To assess the functional outcomes post-fixation, including bite force & occlusal stability. To evaluate the complications such as wound infection, wound dehiscence, hardware failure, & neurosensory disturbances following fixation Timepoint: Radiographic alignment of fractures - Preoperative, postoperative day 1, after 3 months Bite force & occlusal stability, Wound infection, wound dehiscence, hardware failure, & neurosensory disturbance - a day before surgery, after surgery day-1, after 6 weeks & 3 months

Countries

India

Contacts

Public ContactDrPavithraM

AIIMS, Mangalagiri, Andhra Pradesh - 522503

jitendra.dental@aiimsmangalagiri.edu.in7350521361

Outcome results

None listed

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