Comparison of the Post-operative Efficacy of Arch Bar With Single Plate and Two Plate Fixation in Mandibular Parasymphsis Fracture.

Efficacy Of Mandibular Parasymphysis Fracture Treatment With Two Miniplates Versus One Miniplate With Arch Bar

This clinical trial is designed to compare post-operative infection, symptoms of paresthesia, inferior border misalignment and operating time of one plate with arch bar against standard two miniplates in mandibular parasymphysis fracture in order to achieve the treatment which is beneficial for the patients. This study will contribute to literature for the betterment of patient.

The objective of this study is to compare the post-operative efficacy of arch bar with single plate and two plate fixation in mandibular parasymphsis fracture.

Study Overview

• Status: Completed
• Conditions: Mandible Fracture
• Intervention / Treatment: Device: Titanium miniplates; Other: Arch Bar

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab Province
    • Taxila, Punjab Province, Pakistan, 47070
      • Dental College Hitec Institute Of Medical Sciences Taxila Cantt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• All patients with mandibular unilateral parasymphysis fracture

Exclusion Criteria:

1. Mandibular defect fractures.
2. Grossly comminuted fractures.

3. Medically compromised patient.(e.g uncontrolled metabolic disease

   • immunocompromised patient, patient receiving radiation and chemotherapy).
4. Multiple fracture of Mandible.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Titanium miniplates; Titanium miniplates are used in open reduction and internal fixation for facial fractures including mandible fractures.One miniplate is placed on superior border and other is placed at inferior border for mandible parasymphysis fracture.	Device: Titanium miniplates; Titanium miniplates are used for open reduction and internal fixation in mandible fractures according to Champy's principle of osteosynthesis
Other: Arch bars; One Arch bar placed in tension zone for closed reduction technique in mandible fractures is combined with single miniplate placed at the lower border and its efficacy will be compared with two miniplates group	Other: Arch Bar; Arch bars are used for intermaxillary fixation in facial fractures as a mean of closed reduction.In this study arch bars placed in tension zone will be combined with single miniplate placed at inferior border of mandible and this modality efficacy will be compared with two miniplate group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Osseous alignment	It is checked after the surgical procedure by evaluating the continuity of lower border of mandible on orthopentomogram on first post-operative day, after 15 days and after 1 month	Final Alignment will be checked after one month

Collaborators and Investigators

• Sponsor: HITEC-Institute of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Actual): June 30, 2025
• Study Completion (Actual): June 30, 2025

Study Registration Dates

• First Submitted: March 24, 2025
• First Submitted That Met QC Criteria: March 24, 2025
• First Posted (Actual): March 26, 2025

Study Record Updates

• Last Update Posted (Estimated): October 8, 2025
• Last Update Submitted That Met QC Criteria: October 3, 2025
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Fractures, Bone; Craniocerebral Trauma; Trauma, Nervous System; Facial Injuries; Jaw Fractures; Maxillofacial Injuries; Skull Fractures; Mandibular Fractures
• Other Study ID Numbers: fatimakhattak12@gmail.com

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: it is not required for this study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes