Fracture Pattern Following Bilateral Sagittal Split Osteotomy With or Without Impacted Third Molars

Kimie Bols Østergaard

Status: Not yet enrolling

Conditions: Impacted Third Molar Tooth; Mandibular Fractures; Osteotomy; Orthognathic Surgery

Treatments: Procedure: Interoperative wisdom tooth removal in conjunction with BSSO

Study type: Interventional

Funder types: Other

Identifiers

NCT06338982

N-20230059

Details and patient eligibility

About

The goal of this clinical trial is to investigate the hypothesis that there are none difference in the treatment result of orthognathic surgery on the lower jaw, with interoperative wisdom tooth removal rather than preoperative wisdom tooth removal. In patients with severe dental malocclusion combined with a dentofacial deformity. The main question it aims to answer are:

• Is there a difference in the degree of complication and the patient's perception, with inter-operative wisdom tooth removal rather than pre-operative wisdom tooth removal.

Participants will be will be divided into two groups, with one group having their wisdom teeth removed 6 months before their jaw moving surgery and the other group having their wisdom teeth removed in connection with their jaw moving surgery.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients scheduled for surgical correction of facial deformities involving BSSO or bimaxillary surgery with bilateral asymptomatic impacted mandibular third molars
• Age between 18 and 75 years

Exclusion criteria

• Fully erupted and well-functioning mandibular third molar
• Unilateral impacted mandibular third molar
• Pathology associated with the impacted mandibular third molar
• BSSO combined with genioplasty
• Previous mandibular fractures
• Present neurosensory disturbances of the inferior alveolar nerve
• Systemic bone disease or arthritis
• Physical status classification system, ASA Class III or IV, specified patients with severe systemic disease ore patients with severe systemic disease that is constant threat to life
• Failure to attend the entire observation period

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Test group with interoperative wisdom tooth removal in conjunction with BSSO

Experimental group

Treatment:

Procedure: Interoperative wisdom tooth removal in conjunction with BSSO

Control group with wisdom tooth removal at least 6 months before BSSO

No Intervention group