z Mini-plate With Lingual Extension Versus Conventional 2 Mini Plates

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorFayoum University

About this trial

The collected patients according to the eligibility criteria will be randomly distributed into one of these groups:

Group I : 10 patients suffering class III mandibular fracture will be managed by patient specific Z shape mini-plate with lingual extension (study group).

Group II : 10 patients suffering class III mandibular fracture will be managed by 2 mini plates at superior and inferior borders (control group).

The allocation sequence will be generated using computerized random numbers and kept in sealed envelopes, which will be opened prior to surgery. All patients will provide the informed consent after declaration the procedures, benefits, and harms

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

- Class III mandibular fracture

medically stable patient

aged above 21 years

no medical condition affect the bone healing

Disqualifiers

• absence of other facial trauma, mandibular condylar fracture

patient refuse the follow up

Trial design

Design model

Parallel

Treatments tested in this trial

  • z mini plate with lingual extension

    Procedure/Surgery

    patient with class III mandible fracture will be treated with patient specific z mini plate with lingual extension

  • conventional 2 mini plates

    Procedure/Surgery

    patient with class III mandible fracture will be treated with conventional 2 mini plates

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: z miniplate with lingual extensionExperimental treatment 1 intervention
Group B: two mini plateActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

inter condylar distance

Time frame
3 months

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: