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The Effect of Splint Usage in Laterognathic Cl III Orthognathic Surgery Patients

The Effect of Splint Usage in Laterognathic Cl III Orthognathic Surgery Patients: Controlled Clinical Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05216874
Acronym
TMJ
Enrollment
48
Registered
2022-02-01
Start date
2022-01-13
Completion date
2023-01-20
Last updated
2022-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Class III Malocclusion, Laterognathia, Skeletal Malocclusion

Brief 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. 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.

Interventions

Cl III Laterognati volunteer group using occlusal stabilization splint before orthognathic surgery -Splint will be used for at least two months

Sponsors

Bezmialem Vakif University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Masking description

Although it will be explained to the patients that they would be included in a study determining the joint positions and that a bite record would be taken from them during the operation for this purpose, they will not informed about whether they are included in the splint treatment group or the control group.

Intervention model description

Preoperative occlusal splint treatment Cl III Laterognathia patients

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* being ready for orthognathic surgery * must be able to give centric relation records

Exclusion criteria

* having any TMDsyndromes * cleft lip and palate, * have bruxism, * TMJ or muscle disfunctions, * under any medication of muscle relaxants, * narcotics and antidepressants, * usage of removeable prosthetics * have toothless areas that can affect the wax impression for centric record * used horizontal elastics within the last 2 months

Design outcomes

Primary

MeasureTime frameDescription
MPI Records for Splint Users12 monthsDifference 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.

Countries

Turkey (Türkiye)

Contacts

Primary ContactKılıç
bkilic@bezmialem.edu.tr+905322432756

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026