Clinical trial NCT06338982: Fracture Pattern Following Bilateral Sagittal Split Osteotomy With or Without Impacted Third Molars
Official title: Fracture Pattern Following Bilateral Sagittal Split Osteotomy With or Without Impacted Third A Randomized Controlled Trial Assessing Fracture Pattern, Condylar Segment Positioning, Complications and Patient-reported Outcome Measures
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Impacted Third Molar Tooth
Osteotomy
Orthognathic Surgery
Mandibular Fractures
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
First posted: 2024-04-01
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial with a test group and a control group.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Fracture pattern following BSSO with or without impacted third molars
timeFrame: 1 week after det BSSO surgery
measure: Condylar segment position following BSSO with or without impacted third molars
timeFrame: 1 week after det BSSO surgery
measure: Oral Health Impact Profile-14 (OHIP-14)
timeFrame: Hand out questionnaires at the following five times, Enrolment, immediately prior to BSSO, One week after BSSO, One months after BSSO and One-year after BSSO
measure: The Modified Dental Anxiety Scale (MDAS)
timeFrame: Hand out questionnaires at the following three times, Enrolment, immediately prior to BSSO and One-year after BSSO
measure: Short Form-36 (SF-36)
timeFrame: Hand out questionnaires at the following five times, Enrolment, immediately prior to BSSO, One week after BSSO, One months after BSSO and One-year after BSSO
measure: PROMs
timeFrame: Hand out questionnaires at the following two times, One week after BSSO and One months after BSSO.
Secondary outcomes:
measure: Length of the surgical procedure
timeFrame: Interoperative in connection with the BSSO surgery
measure: Intraoperative bleeding
timeFrame: Interoperative in connection with the BSSO surgery
measure: Frequency of intra- and postoperative complications
timeFrame: One week, one months and one-year after BSSO
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg universitets hospital
Study officials:
References: