Impacted Third Molar ToothNCT06338982
Fracture Pattern Following Bilateral Sagittal Split Osteotomy With or Without Impacted Third Molars
A study testing Interoperative wisdom tooth removal in conjunction with BSSO in people with Impacted Third Molar Tooth and Osteotomy, run by Kimie Bols Østergaard at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Impacted Third Molar Tooth, Osteotomy, Orthognathic Surgery
- What is being tested?
- Interoperative wisdom tooth removal in conjunction with BSSO
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteDenmark
- Study dates
- 30 Mar 2024to 31 Oct 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
- Being tested
- Interoperative wisdom tooth removal in conjunction with BSSO
- Medical subject headings
- Mandibular Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interoperative wisdom tooth removal in conjunction with BSSOProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Test group with interoperative wisdom tooth removal in conjunction with BSSO | Experimental | Not described Receives: Procedure: Interoperative wisdom tooth removal in conjunction with BSSO |
| Control group with wisdom tooth removal at least 6 months before BSSO | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
The intraoperative length of BSSO will be measured by a stopwatch (iPhone 14 Pro or similar) from the incision to the last suture in both groups. The intraoperative length of BSSO will be registered by the surgeon.
Measured: Interoperative in connection with the BSSO surgery
Intraoperative bleeding
The intraoperative blood loss will be estimated by measuring suctioned blood, and then adjusted for the used volume of saline irrigation during BSSO. If the patient is undergoing bimaxillary surgery, then the blood loss will solely be calculated and registered for the BSSO. The intraoperative blood loss will be registered by the surgeon.
Measured: Interoperative in connection with the BSSO surgery
Frequency of intra- and postoperative complications
Frequency of intra- and postoperative complications including visualization and injury of the inferior alveolar nerve, heavy bleeding, or unfavorable fracture patterns will be registered by the surgeon.
Postoperative complications including temporary or permanent neurosensory disturbances of the inferior alveolar nerve and infection will be registered by the surgeon. Infection will be registered according to the criteria for surgical site infection event (SSI) stated by the center of disease control.
Measured: One week, one months and one-year after BSSO
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start30 Mar 2024 (estimated)
- Primary completion31 Oct 2029 (estimated)
- Study completion31 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impacted Third Molar ToothStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial with a test group and a control group.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kimie Bols Østergaard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kimie Bols Østergaard, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06338982
- Sponsor's protocol ID
- N-20230059
- Status last verified
- Mar 2024
- First submitted
- 2 Mar 2024
- Last updated
- 1 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06338982
- Acronym / sponsor ID
- N-20230059
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Kimie Bols ØstergaardUniversity, hospital or other
- Study start
- 30 Mar 2024 (estimated)
- Primary completion
- 31 Oct 2029 (estimated)
- Study completion
- 31 Oct 2030 (estimated)
- First posted
- 1 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial with a test group and a control group.
| Arm | Type | Receives |
|---|---|---|
| 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 | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interoperative wisdom tooth removal in conjunction with BSSOThe 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. | Procedure or surgery | Test group with interoperative wisdom tooth removal in conjunction with BSSO |
Primary outcome
Fracture pattern following BSSO with or without impacted third molars
Time frame: 1 week after det BSSO surgery
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.
Condylar segment position following BSSO with or without impacted third molars
Time frame: 1 week after det BSSO surgery
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).
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
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
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
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.
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
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.
PROMs
Time frame: Hand out questionnaires at the following two times, One week after BSSO and One months after BSSO.
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interoperative wisdom tooth removal in conjunction with BSSO in people with Impacted Third Molar Tooth and Osteotomy, run by Kimie Bols Østergaard at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fracture pattern following BSSO with or without impacted third molars (time frame: 1 week after det BSSO surgery). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2024.