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

NCT06895174 | Completed DMC FDA Device

• 1 other identifier: fatimakhattak12@gmail.com
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mandible Fracture

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Titanium miniplates

ACTIVE COMPARATOR

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

Arch bars

OTHER

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

Interventions

Titanium miniplates DEVICE

Titanium miniplates are used for open reduction and internal fixation in mandible fractures according to Champy's principle of osteosynthesis

Titanium miniplates

Arch Bar OTHER

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.

Arch bars

Eligibility Criteria

• Age: 17 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• All patients with mandibular unilateral parasymphysis fracture

You may not qualify if:

• Mandibular defect fractures.
• Grossly comminuted fractures.
• Medically compromised patient.(e.g uncontrolled metabolic disease
• immunocompromised patient, patient receiving radiation and chemotherapy).
• Multiple fracture of Mandible.

Sponsors & Collaborators

• HITEC-Institute of Medical Sciences: lead

Study Sites (1)

Dental College Hitec Institute Of Medical Sciences Taxila Cantt

Taxila, Punjab Province, 47070, Pakistan

Location

MeSH Terms

Conditions

Mandibular Fractures

Condition Hierarchy (Ancestors)

Jaw Fractures; Maxillofacial Injuries; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Skull Fractures; Fractures, Bone; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Oral & Maxillofacial Surgery

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: March 26, 2025
• Study Start: July 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: October 8, 2025

Record last verified: 2024-07

Locations

PA (1)