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

NCT ID: NCT06338982

Last Updated: 2024-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-30

Study Completion Date

2030-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Impacted Third Molar Tooth Osteotomy Orthognathic Surgery Mandibular Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial with a test group and a control group.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Test group with interoperative wisdom tooth removal in conjunction with BSSO

Group Type EXPERIMENTAL

Interoperative wisdom tooth removal in conjunction with BSSO

Intervention Type 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.

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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 prior their BSSO surgery.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kimie Bols Østergaard

OTHER

Sponsor Role lead

Responsible Party

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Kimie Bols Østergaard

Doctor of Dental Surgery

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Aalborg universitets hospital

Aalborg, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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N-20230059

Identifier Type: -

Identifier Source: org_study_id

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