Cleft Lip and PalateNCT05876169
How Does Orthognathic Surgery Affect Jaw and Neck Motor Function?
A study testing Orthognathic surgery in people with Cleft Lip and Palate, run by Umeå University at 1 site in Sweden.
Trial summary
In a prospective longitudinal study design, details in jaw-neck kinematics and electromyography (EMG) activity changes in patients (women and men) referred for surgical correction of basal relations between the maxilla and mandible over time; pre-operative and during follow-up 8 weeks and 18 months after surgical… Read more about this study
- Who is it for?
- Ages 16 to 50 years
- Conditions the study is for
- Cleft Lip and Palate
- What is being tested?
- Orthognathic surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- 6 Sep 2022to 12 Dec 2026
- 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 16 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients accepted for orthognathic surgery due to jaw discrepancies.
- Patients given their consent for participation
Who cannot join
- Patients with syndromes
- Patients not given their consent for participation
- Patients unable to follow instructions due to lack of knowledge in Swedish and/or English language
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site
Faculty of Medicine, Department of Odontology, Umeå University
Umeå
About this study
In a prospective longitudinal study design, details in jaw-neck kinematics and electromyography (EMG) activity changes in patients (women and men) referred for surgical correction of basal relations between the maxilla and mandible over time; pre-operative and during follow-up 8 weeks and 18 months after surgical correction will be evaluated. The results will contribute with novel insights on jaw-neck motor function before, in short- and long-term after the surgical process. We will have blinded evaluation of outcomes.
Read the detailed description
Consecutive patients referred to department of Oral and Maxillofacial Surgery, Umeå University Hospital for corrective maxillofacial-mandibular surgery, will offer opportunity to be included in the study. Expected number of patients: 20 - 25 patients annually. Blinded evaluation will be pre-operative and during follow-up 8 weeks and 18 months after surgical correction.
- Conditions
- Cleft Lip and Palate
- Being tested
- Orthognathic surgery
- Keywords
- Orthognathic Surgery, Cleft Lip and Palate
- Medical subject headings
- Cleft Lip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orthognathic surgeryProcedure or surgery
Also called Kinematic of jaw and head movements, muscle activity, bite force, occlusal contact area
Surgical corrections of the maxilla and/or the mandible. Integrated jaw-neck movement patterns, muscle activity, bite force and occlusal contact area will be registered and mapped with quantitative objective functional variables. The state-of-the-art core equipment to evaluate jaw-neck motor function in detail is located in the Movement Lab (Department of Odontology, Umeå University).
| Study group | Role | What they receive |
|---|---|---|
| Prospective longitudinal study design | Other | Patients that will undergo orthognatic surgery will be given opportunity to participate in jaw and neck motor function analysis. Receives: Procedure: Orthognathic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Kinematic outcome variables
Jaw and head movement amplitudes (mm)
Measured: Preoperatively, postoperatively 8 weeks, 18 months
Change in Kinematic outcome variables
Movement cycle time (s)
Measured: Preoperatively, postoperatively 8 weeks, 18 months
Change in Kinematic outcome variables
Movement acceleration from start to peak (mm/s2)
Measured: Preoperatively, postoperatively 8 weeks, 18 months
Change in Kinematic outcome variables
Jaw movement area (mm2)
Measured: Preoperatively, postoperatively 8 weeks, 18 months
Change in Kinematic outcome variables
Jaw movement volume (mm3)
Measured: Preoperatively, postoperatively 8 weeks, 18 months
Change in Electromyography (EMG)
Muscle activity in micro-Volt in jaw and neck muscles bilaterally
Measured: Preoperatively, postoperatively 8 weeks, 18 months
Change in Maximum voluntary occlusal bite force (MVOBF)
Newton (N)
Measured: Preoperatively, postoperatively 8 weeks, 18 months
Change in Occlusal contact area
mm2
Measured: Preoperatively, postoperatively 8 weeks, 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start6 Sep 2022
- Primary completion12 Dec 2026 (estimated)
- Study completion12 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cleft Lip and PalateStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05876169
- Sponsor's protocol ID
- 2022-kakfunktion
- Status last verified
- May 2023
- First submitted
- 2 May 2023
- Last updated
- 25 May 2023
- 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 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Does Orthognathic Surgery Affect Jaw and Neck Motor Function?
- ClinicalTrials.gov ID
- NCT05876169
- Acronym / sponsor ID
- 2022-kakfunktion
- Conditions
- Cleft Lip and Palate
- Keywords
- Orthognathic Surgery, Cleft Lip and Palate
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- 6 Sep 2022 (actual)
- Primary completion
- 12 Dec 2026 (estimated)
- Study completion
- 12 Dec 2026 (estimated)
- First posted
- 25 May 2023 (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.
In a prospective longitudinal study design, details in jaw-neck kinematics and electromyography (EMG) activity changes in patients (women and men) referred for surgical correction of basal relations between the maxilla and mandible over time; pre-operative and during follow-up 8 weeks and 18 months after surgical correction will be evaluated. The results will contribute with novel insights on jaw-neck motor function before, in short- and long-term after the surgical process. We will have blinded evaluation of outcomes.
Detailed description
Consecutive patients referred to department of Oral and Maxillofacial Surgery, Umeå University Hospital for corrective maxillofacial-mandibular surgery, will offer opportunity to be included in the study. Expected number of patients: 20 - 25 patients annually. Blinded evaluation will be pre-operative and during follow-up 8 weeks and 18 months after surgical correction.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospective longitudinal study design | Other | Procedure: Orthognathic surgeryPatients that will undergo orthognatic surgery will be given opportunity to participate in jaw and neck motor function analysis. |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Patients accepted for orthognathic surgery due to jaw discrepancies.
- Patients given their consent for participation
Key exclusion criteria (3 listed)
- Patients with syndromes
- Patients not given their consent for participation
- Patients unable to follow instructions due to lack of knowledge in Swedish and/or English language
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 |
|---|---|---|
| Orthognathic surgeryAlso: Kinematic of jaw and head movements, muscle activity, bite force, occlusal contact areaSurgical corrections of the maxilla and/or the mandible. Integrated jaw-neck movement patterns, muscle activity, bite force and occlusal contact area will be registered and mapped with quantitative objective functional variables. The state-of-the-art core equipment to evaluate jaw-neck motor function in detail is located in the Movement Lab (Department of Odontology, Umeå University). | Procedure or surgery | Prospective longitudinal study design |
Primary outcome
Change in Kinematic outcome variables
Time frame: Preoperatively, postoperatively 8 weeks, 18 months
Jaw and head movement amplitudes (mm)
Change in Kinematic outcome variables
Time frame: Preoperatively, postoperatively 8 weeks, 18 months
Movement cycle time (s)
Change in Kinematic outcome variables
Time frame: Preoperatively, postoperatively 8 weeks, 18 months
Movement acceleration from start to peak (mm/s2)
Change in Kinematic outcome variables
Time frame: Preoperatively, postoperatively 8 weeks, 18 months
Jaw movement area (mm2)
Change in Kinematic outcome variables
Time frame: Preoperatively, postoperatively 8 weeks, 18 months
Jaw movement volume (mm3)
Change in Electromyography (EMG)
Time frame: Preoperatively, postoperatively 8 weeks, 18 months
Muscle activity in micro-Volt in jaw and neck muscles bilaterally
Change in Maximum voluntary occlusal bite force (MVOBF)
Time frame: Preoperatively, postoperatively 8 weeks, 18 months
Newton (N)
Change in Occlusal contact area
Time frame: Preoperatively, postoperatively 8 weeks, 18 months
mm2
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 25 May 2023.
- Individual participant dataSharing planned: No
Related trials for Cleft Lip and Palate
Not yet recruiting
Comparative Study of Regional Nerve Blocks in Primary Cleft Palate Repair
Cleft Lip, Cleft Palate +/- Lip
Not yet recruiting
Quadratus Lumborum Block for Iliac Bone Harvest in Pediatric Cleft Alveolus Repair
Cleft Lip Palate
RecruitingObservational study
Perceptions of High and Low Intensity Speech Intervention in Children With a Cleft Palate
Cleft Lip and Palate, Cleft Palate Children
Not yet recruitingPhase 3
Safety and Efficacy of Bone Bioengineering Kit With Stem Cells for Alveolar Cleft Repair
Cleft Lip Palate
Enrolling by invitation
Speech Intervention Frameworks in Cantonese-speaking Children and Adolescences With Cleft Palate +/- Lip
Cleft Palate +/- Lip
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 Orthognathic surgery in people with Cleft Lip and Palate, run by Umeå University at 1 site in Sweden.
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 3 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: enrolling by invitation, as of the sponsor's last update on 25 May 2023. 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 Sweden. 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?
Change in Kinematic outcome variables (time frame: Preoperatively, postoperatively 8 weeks, 18 months). The study lists 8 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 25 May 2023.