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

NCT ID: NCT06895174

Last Updated: 2025-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-01

Study Completion Date

2025-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Mandible Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Titanium miniplates

Intervention Type DEVICE

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

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

Group Type OTHER

Arch Bar

Intervention Type 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.

Interventions

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Titanium miniplates

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

Intervention Type DEVICE

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

17 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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HITEC-Institute of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Fatima Khattak

Assistant Professor Oral & Maxillofacial Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Dental College Hitec Institute Of Medical Sciences Taxila Cantt

Taxila, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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[email protected]

Identifier Type: -

Identifier Source: org_study_id

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