Menu
Not yet recruiting NCT06338982

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

No phase Interventional Impacted Third Molar Tooth Osteotomy Orthognathic Surgery Mandibular Fractures

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Interoperative wisdom tooth removal in conjunction with BSSO.
Who it may be relevant to
Registry conditions: Impacted Third Molar Tooth, Osteotomy, Orthognathic Surgery, Mandibular Fractures. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Procedure Interoperative wisdom tooth removal in conjunction with BSSO
    The objective of the present randomized controlled trial is to assess the fracture pattern, condylar segment positioning, frequency of complications, and PROMs following BSSO with or without impacted mandibular third molars. this is illustrated by the fact that the test group had their wisdom teeth removed in connection with the sagittal split of the mandible (the BSSO surgery). Subsequently, all outcome measures are compared with the control group, who had their wisdom teeth removed 6 months pr

Primary outcome measures

  • Fracture pattern following BSSO with or without impacted third molars [Time frame: 1 week after det BSSO surgery]
  • Condylar segment position following BSSO with or without impacted third molars [Time frame: 1 week after det BSSO surgery]
  • Oral Health Impact Profile-14 (OHIP-14) [Time frame: 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]
  • The Modified Dental Anxiety Scale (MDAS) [Time frame: Hand out questionnaires at the following three times, Enrolment, immediately prior to BSSO and One-year after BSSO]
  • Short Form-36 (SF-36) [Time frame: 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]
  • PROMs [Time frame: Hand out questionnaires at the following two times, One week after BSSO and One months after BSSO.]
Secondary outcome measures (3)
  • Length of the surgical procedure [Time frame: Interoperative in connection with the BSSO surgery]
  • Intraoperative bleeding [Time frame: Interoperative in connection with the BSSO surgery]
  • Frequency of intra- and postoperative complications [Time frame: One week, one months and one-year after BSSO]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Denmark · 1 center
  • Aalborg universitets hospital — Aalborg

Identifiers

NCT: NCT06338982 · N-20230059

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗