Accuracy of Maxillary Fixation Using Custom Plates on Nasal Buttress Only Via Minimally Invasive Approach Versus Custom Plates on Nasal and Zygomatic Buttresses Via Conventional Approach in Orthognathic Surgeries

Cairo University (CU)

Status: Not yet enrolling

Conditions: Orthognathic Surgery

Treatments: Procedure: Maxilla fixation using custom plates on nasal and zygomatic buttresses via conventional vestibular approach.; Procedure: minimally invasive maxillary fixation

Study type: Interventional

Funder types: Other

Identifiers

NCT07311785

Omfs 3-3-19

Details and patient eligibility

About

The goal of this clinical trial is to evaluate of the accuracy maxilla fixation using custom plates on nasal buttress only via minimally invasive approach versus using custom plates on nasal and zygomatic buttresses via conventional approach. The main question it aims to answer is:

• Is the minimally invasive approach accurate and stable ? Researchers will compare minimally invasive technique to the traditional technique of fixation of the maxilla bone to see if it is as accurate and stable.

Participants will:

• Undergo surgey
• Follow up visits weekly for a month then on a monthly basis for 5 more months.

Enrollment: 30 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with dentofacial disharmony and misalignment requiring bimaxillary orthognathic surgeries.
• Patients with no signs or symptoms of active TMDs.
• Highly motivated patients.

Exclusion criteria

• Patients who refused to be included in the research.
• Patients with systemic diseases that may hinder the normal healing process or render the patient not fitting for general anaesthesia.
• Patients with intra-bony lesions or infections that may retard the osteotomy healing.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

intervention

Experimental group

Description:

Maxilla fixation using custom plates on nasal buttress only via minimally invasive approach.

Treatment:

Procedure: minimally invasive maxillary fixation

control

Active Comparator group

Description:

Maxilla fixation using custom plates on nasal and zygomatic buttresses via conventional vestibular approach.

Treatment:

Procedure: Maxilla fixation using custom plates on nasal and zygomatic buttresses via conventional vestibular approach.