Health TrialsbyHealthPanel

Sagittal Split Plate Versus Two Miniplates in the Treatment of Mandibular Angle Fractures

ConditionMandible Fracture
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-50
SponsorAlexandria University

About this trial

Mandibular fractures are the second most common maxillofacial fracture after nasal bone fracture. As a result, a lot of research work has gone into improving treatment methods for these fractures including, reduction of immobilization period and enhancement of rigid fixation. One of these modalities is the use of Sagittal Split plate at the angle of the mandible.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients suffering from recent, uninfected angle mandibular fracture.

Fracture that demands open reduction and internal fixation.

Disqualifiers

Medically compromised patients contradicting the operation.

Existence of infection at the fracture line.

Pathological fracture.

An old fracture.

Trial design

Design model

Parallel

Treatments tested in this trial

  • single Sagittal Split plate

    Procedure/Surgery

    patients will be treated using a single Sagittal Split plate at the neutral zone of mandible

  • two conventional miniplates

    Procedure/Surgery

    patients will be treated using two conventional miniplates according to Champy's osteosynthesis lines.

Treatment groups

16 Participants
are divided into 2 treatment groups
Group A: Test GroupExperimental treatment 1 intervention
Group B: Conventional GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in pain scores

Will be assessed through a 10-point Visual Analogue Scale (VAS) (34). (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe).

Time frame
baseline, 24 hours, 1 week, and 6 weeks
2

Change in Maximal Inter-Incisal Mouth

Using a millimeter ruler to measure maximal inter-incisal mouth opening

Time frame
baseline, 24 hours, 1 week, and 6 weeks

Secondary outcomes

1

postoperative infection

observation for any manifestations of wound healing disturbance

Time frame
24 hours, 1 week, and 6 weeks
2

change in bone density

Immediate CT (T0) scan will be done and then another CT (T1) will be taken at 12th week to estimate the mean bone density at the fracture line in comparison with the immediate postoperative scan

Time frame
baseline and 12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Alexandria University

Lead sponsor

Source ClinicalTrials.gov
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