Skeletal MalocclusionTMJNCT05216874
The Effect of Splint Usage in Laterognathic Cl III Orthognathic Surgery Patients
A study testing Oclusal Splint in people with Skeletal Malocclusion and Class III Malocclusion, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
It is crucial to maintain the anatomic condylar positions during orthognathic surgery. Condylar positions are affected directly under general anesthesia because of joint and muscle relaxation. Possible unwanted changes in the joint position may cause incorrect positioning of the jawbones. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skeletal Malocclusion, Class III Malocclusion, Laterognathia
- What is being tested?
- Oclusal Splint
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Jan 2022to 20 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- being ready for orthognathic surgery
- must be able to give centric relation records
Who cannot join
- having any TMDsyndromes
- cleft lip and palate,
- have bruxism,
- TMJ or muscle disfunctions,
- under any medication of muscle relaxants,
- narcotics and antidepressants,
Show all 9Show fewer
- usage of removeable prosthetics
- have toothless areas that can affect the wax impression for centric record
- used horizontal elastics within the last 2 months
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Banu Kılıç
Fatih, Istanbul, 34093
Banu Kılıç, 05322432756, bkilic@bezmialem.edu.tr
About this study
Official title: The Effect of Splint Usage in Laterognathic Cl III Orthognathic Surgery Patients: Controlled Clinical Trial
It is crucial to maintain the anatomic condylar positions during orthognathic surgery. Condylar positions are affected directly under general anesthesia because of joint and muscle relaxation. Possible unwanted changes in the joint position may cause incorrect positioning of the jawbones. This could affect the success of the surgery in terms of function and facial aesthetics causing the need for a second surgery. Our aim is to evaluate whether the use of MR Splint has a statistically significant effect on muscle relaxation-induced condyle position deviations under general anesthesia in Class III Laterognathia patients.
Read the detailed description
It is crucial to maintain the anatomic condyle positions during orthognathic surgery to prevent iatrogenic temporomandibular joint complications. Condyle shunts are affected directly under general anesthesia because of the joint and muscle relaxation. Surgical guidance appliances are prepared according to the TMJ records taken chairside while patients are in an upright position. During surgery, these appliances are applied in a supine position while the muscles are relaxed. Postoperative and long-term effects of TMJ and muscle relaxation obtained under general anesthesia in class III and asymmetric patients will be examined. Patients who had occlusal splint before records taken will be evaluated in terms of condyle location by MPI.
Our aim is to evaluate whether the use of MR Splint has a statistically significant effect on muscle relaxation-induced condyle position deviations under general anesthesia in Class III Laterognathia patients.
- Conditions
- Skeletal Malocclusion, Class III Malocclusion, Laterognathia
- Being tested
- Oclusal Splint
- Medical subject headings
- Malocclusion, Angle Class III
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oclusal SplintDevice
Cl III Laterognati volunteer group using occlusal stabilization splint before orthognathic surgery
-Splint will be used for at least two months
| Study group | Role | What they receive |
|---|---|---|
| Occlusal stabilization splint | Experimental | Skeletal class III laterognathia surgery patients who has occlusal stabilization splint thearapy for at least 2 mounths before surgery Receives: Device: Oclusal Splint |
| Control | No intervention | Skeletal class III laterognathia surgery patients did not have occlusal stabilization splint thearapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
MPI Records for Splint Users
Difference between preoperative and intraoperative condylar positions will be observed as mm with bite records. MPI will be used in the lab to determine the difference.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start13 Jan 2022
- Primary completion20 Aug 2022 (estimated)
- Study completion20 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skeletal MalocclusionStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Preoperative occlusal splint treatment Cl III Laterognathia patients
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Banu Kılıç, Bezmialem Vakif University
- Investigators
- Banu Kılıç, asst. prof, Study director, Bezmialem Vakıf Üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05216874
- Sponsor's protocol ID
- laterognathia MPI
- Acronym
- TMJ
- Status last verified
- Feb 2022
- First submitted
- 19 Jan 2022
- Last updated
- 3 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Splint Usage in Laterognathic Cl III Orthognathic Surgery Patients: Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05216874
- Acronym / sponsor ID
- TMJ / laterognathia MPI
- Conditions
- Skeletal Malocclusion, Class III Malocclusion, Laterognathia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 13 Jan 2022 (actual)
- Primary completion
- 20 Aug 2022 (estimated)
- Study completion
- 20 Jan 2023 (estimated)
- First posted
- 1 Feb 2022 (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.
It is crucial to maintain the anatomic condylar positions during orthognathic surgery. Condylar positions are affected directly under general anesthesia because of joint and muscle relaxation. Possible unwanted changes in the joint position may cause incorrect positioning of the jawbones. This could affect the success of the surgery in terms of function and facial aesthetics causing the need for a second surgery. Our aim is to evaluate whether the use of MR Splint has a statistically significant effect on muscle relaxation-induced condyle position deviations under general anesthesia in Class III Laterognathia patients.
Detailed description
It is crucial to maintain the anatomic condyle positions during orthognathic surgery to prevent iatrogenic temporomandibular joint complications. Condyle shunts are affected directly under general anesthesia because of the joint and muscle relaxation. Surgical guidance appliances are prepared according to the TMJ records taken chairside while patients are in an upright position. During surgery, these appliances are applied in a supine position while the muscles are relaxed. Postoperative and long-term effects of TMJ and muscle relaxation obtained under general anesthesia in class III and asymmetric patients will be examined. Patients who had occlusal splint before records taken will be evaluated in terms of condyle location by MPI.
Our aim is to evaluate whether the use of MR Splint has a statistically significant effect on muscle relaxation-induced condyle position deviations under general anesthesia in Class III Laterognathia patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Preoperative occlusal splint treatment Cl III Laterognathia patients
| Arm | Type | Receives |
|---|---|---|
| Occlusal stabilization splint | Experimental | Device: Oclusal SplintSkeletal class III laterognathia surgery patients who has occlusal stabilization splint thearapy for at least 2 mounths before surgery |
| Control | No intervention | –Skeletal class III laterognathia surgery patients did not have occlusal stabilization splint thearapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- being ready for orthognathic surgery
- must be able to give centric relation records
Key exclusion criteria (9 listed)
- having any TMDsyndromes
- cleft lip and palate,
- have bruxism,
- TMJ or muscle disfunctions,
- under any medication of muscle relaxants,
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 |
|---|---|---|
| Oclusal SplintCl III Laterognati volunteer group using occlusal stabilization splint before orthognathic surgery -Splint will be used for at least two months | Device | Occlusal stabilization splint |
Primary outcome
MPI Records for Splint Users
Time frame: 12 months
Difference between preoperative and intraoperative condylar positions will be observed as mm with bite records. MPI will be used in the lab to determine the difference.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2022.
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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. This study is not recruiting at the moment.
Banu Kılıç, asst. prof study director
Bezmialem Vakıf Üniversitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oclusal Splint in people with Skeletal Malocclusion and Class III Malocclusion, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
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: status not confirmed, as of the sponsor's last update on 3 Feb 2022. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kılıç (+905322432756, bkilic@bezmialem.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MPI Records for Splint Users (time frame: 12 months). 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 3 Feb 2022.