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Outcome Measures

Primary Outcomes (1)

Bone density
Bone mineral density recovery at the fracture site, will be analyzed using Hounsfield Units (HU).
Patients will undergo multi-slice CT scanning at baseline (within 1 week) and at 6 months postoperatively to assess the recovery.

Secondary Outcomes (2)

Postoperative occlusion
One week postoperatively
Incidence of Postoperative Neurosensory Dysfunction
One week postoperatively

Study Arms (2)

Fixation of mandibular body fractures with patient-specific titanium plates.

EXPERIMENTAL

Patients in this group will undergo open reduction and internal fixation (ORIF) using custom-designed titanium plates. The plates are pre-fabricated utilizing computer-aided design and computer-aided manufacturing (CAD/CAM) based on the patient's preoperative 3D computed tomography (CT) data.

Procedure: Open reduction and Internal fixation of a mandibular body fracture

Fixation of mandibular body fractures with conventional plates.

ACTIVE COMPARATOR

Patients in this group will undergo standard open reduction and internal fixation (ORIF) using commercially available, standard stock titanium plates.

Procedure: Open reduction and Internal fixation of a mandibular body fracture

Interventions

Open reduction and Internal fixation of a mandibular body fractureProcedure

Patient-Specific titanium plates designed using virtual 3D planning software and fabricated via computer-aided manufacturing to match the patient's precise pre-injury mandibular anatomy.

Fixation of mandibular body fractures with patient-specific titanium plates.

Open reduction and Internal fixation of a mandibular body fractureProcedure

Commercially available, standard stock titanium plates will be adapted and bent manually by the surgeon during the operation to fit the patient's mandibular anatomy.

Eligibility Criteria

Age18 Years - 55 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64)

You may qualify if:

Unilateral or bilateral mandibular body fracture requiring open reduction and internal fixation (ORIF), presenting either isolated or concurrently with other maxillofacial, midface, or other mandibular fractures.
Patients in good general health who are medically cleared to undergo major maxillofacial surgery under general anesthesia.

Related Publications (13)

Jadhav A, Mundada B, Deshmukh R, Bhutekar U, Kala A, Waghwani K, Mishra A. Mandibular Ramus Fracture: An Overview of Rare Anatomical Subsite. Plast Surg Int. 2015;2015:954314. doi: 10.1155/2015/954314. Epub 2015 Nov 3.

PMID: 26613050BACKGROUND

Leathers R, Le AD, Black E, McQuirter JL. Orofacial injury in underserved minority populations. Dent Clin North Am. 2003 Jan;47(1):127-39. doi: 10.1016/s0011-8532(02)00053-8.

PMID: 12519010BACKGROUND

MeSH Terms

Conditions

Mandibular Fractures

Interventions

Open Fracture Reduction

Condition Hierarchy (Ancestors)

Jaw FracturesMaxillofacial InjuriesFacial InjuriesCraniocerebral TraumaTrauma, Nervous SystemNervous System DiseasesSkull FracturesFractures, BoneWounds and Injuries

Intervention Hierarchy (Ancestors)

Fracture FixationOrthopedic Procedures

Study Design

Study Type

interventional

Phase

not applicable

Allocation

RANDOMIZED

Masking

SINGLE

Who Masked

PARTICIPANT

Masking Details

This is a single-blind clinical trial where only the participant is blinded. Due to the distinct differences in the geometric design, and radiographic appearance of the patient-specific plates versus conventional plates on computed tomography (CT) scans, it is impossible to mask the operating surgeon or the radiological outcome assessor.

Purpose

TREATMENT

Intervention Model

PARALLEL

Sponsor Type

OTHER

Responsible Party

PRINCIPAL INVESTIGATOR

PI Title

Assistant lecturer

Optimized Osteosynthesis: Bone Mineral Density Recovery in Mandibular Body Fractures Using Patient-Specific Versus Conventional Plates

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

Fixation of mandibular body fractures with patient-specific titanium plates.

Fixation of mandibular body fractures with conventional plates.

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (13)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

Fixation of mandibular body fractures with patient-specific titanium plates.

Fixation of mandibular body fractures with conventional plates.

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (13)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations