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

NCT06338982 | Not Yet Recruiting

• 1 other identifier: N-20230059
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (6)

• Fracture pattern following BSSO with or without impacted third molars

  The fracture pattern of the mandible following BSSO will be assessed by CBCT scans (i-CAT; Imaging Sciences International, Hatfield, PA, USA) obtained preoperatively, and one week after surgery. The CBCT will be taken by fixed exposure parameters of 120 kV, 160 × 60 mm field of view, 0.30 mm voxel size, and 8.9-second images. The fracture pattern of the mandible will be classified according to LSS by the study investigator (KBØ). The LSS consisted of 4 categories based on the path of the fracture line on the lingual side of the mandibular ramus.

  1 week after det BSSO surgery

• Condylar segment position following BSSO with or without impacted third molars

  The mandibular condylar segment positioning will be assessed in the sagittal, vertical, and transverse dimension by superimposing the pre- and postoperative CBCT scan using dedicated software (OnDemand3D Application, version 10; Cybermed, Seoul, South Korea). The orbital bony walls on the preoperative CBCT will be used as the reference and matched with the orbital walls on the postoperative CBCT. Pair-wise registration will be done, based on the automated detection of hundreds of virtual landmarks in the volumes, which can subsequently be manually adjusted, based on visible anatomical landmarks.To estimate the condylar displacement in all three dimensions, the intertransverse distance in millimeters between the center of the condyles is measured on the pre- and postoperative CBCT. Moreover, the distance between the mandibular condyle to the glenoid fossa is measured in the sagittal and vertical dimension. The measurements will be conducted by the study investigator (KBØ).

  1 week after det BSSO surgery

• Oral Health Impact Profile-14 (OHIP-14)

  OHIP-14 is a validated questionnaire for assessment of OHRQoL. OHIP-14 states the patient's overall oral impairment and does not take a specific treatment site into account. OHIP-14 is organized into seven conceptual dimensions including functional limitation, physical discomfort, psychological discomfort, physical disability, psychological disability, social disability and handicap. The response format of OHIP-14 is: Very often = 4; Fairly often or many times = 3; Occasionally = 2; Hardly ever or nearly never = 1; Never/I don´t know = 0. Thus, OHIP-14 scale ranged from 0 to 56 and dimension score ranged from 0 to 8. Values of the 14 items and each dimension are summed to calculate the OHIP-14 severity score and higher scores indicate poorer OHRQoL

  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)

  The level of preoperative dental anxiety is assessed by MDAS, which is a brief questionnaire rating patient's emotional reaction to an up-coming dental visit.MDAS consist of five questions in a Likert scale ranging from not anxious (scoring 1), slightly anxious (scoring 2), fairly anxious (scoring 3), very anxious (scoring 4) to extremely anxious (scoring 5) and summed together to produce a total score ranging from 5 to 25. For assessing the level of dental anxiety of each patient, response scores of all 5 questions are added. The total score ranges from 5 to 25 with cut-off scores 14 and 19 suggestive of high dental anxiety and dental phobia.

  Hand out questionnaires at the following three times, Enrolment, immediately prior to BSSO and One-year after BSSO

• Short Form-36 (SF-36)

  SF-36 is a questionnaire for assessment of quality of life. SF-36 is composed of eight multi-item scales (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, Mental Health), with scores for each of these scales (or dimensions) ranging from 0 to 100. Higher scores indicate higher health-related quality of life.

  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

  Patient´s perception of recovery will be assessed by questionnaires and visual analog scale ranging from 0 to 100 higher scores indicate bigger impact on the topic, the questions will assessing pain, number of days with sick leave, social and working isolation, physical appearance, eating and speaking ability, diet variations, sleep impairment, and discomfort as well as questions whether they would undergo similar treatment again, if needed or if they would recommend this treatment to a friend or a relative, if indicated.

  Hand out questionnaires at the following two times, One week after BSSO and One months after BSSO.

Secondary Outcomes (3)

• Length of the surgical procedure

  Interoperative in connection with the BSSO surgery

• Intraoperative bleeding

  Interoperative in connection with the BSSO surgery

• Frequency of intra- and postoperative complications

  One week, one months and one-year after BSSO

Study Arms (2)

Test group with interoperative wisdom tooth removal in conjunction with BSSO

EXPERIMENTAL

Procedure: Interoperative wisdom tooth removal in conjunction with BSSO

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

NO INTERVENTION

Interventions

Interoperative wisdom tooth removal in conjunction with BSSO PROCEDURE

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 prior their BSSO surgery.

Test group with interoperative wisdom tooth removal in conjunction with BSSO

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kimie Bols Østergaard: lead

Study Sites (1)

Aalborg universitets hospital

Aalborg, 9000, Denmark

Location

MeSH Terms

Conditions

Mandibular Fractures

Interventions

beta-sitosterol oleate

Condition Hierarchy (Ancestors)

Jaw Fractures; Maxillofacial Injuries; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Skull Fractures; Fractures, Bone; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor of Dental Surgery

Model Details: Randomized controlled trial with a test group and a control group.

Study Record Dates

• First Submitted: March 2, 2024
• First Posted: April 1, 2024
• Study Start: March 30, 2024
• Primary Completion (Estimated): October 31, 2029
• Study Completion (Estimated): October 31, 2030
• Last Updated: April 1, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)