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

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-13

Study Completion Date

2023-01-20

Brief Summary

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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.

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Detailed Description

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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

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Skeletal Malocclusion Class III Malocclusion Laterognathia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Preoperative occlusal splint treatment Cl III Laterognathia patients

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

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.

Study Groups

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Occlusal stabilization splint

Skeletal class III laterognathia surgery patients who has occlusal stabilization splint thearapy for at least 2 mounths before surgery

Group Type EXPERIMENTAL

Oclusal Splint

Intervention Type DEVICE

Cl III Laterognati volunteer group using occlusal stabilization splint before orthognathic surgery

-Splint will be used for at least two months

Control

Skeletal class III laterognathia surgery patients did not have occlusal stabilization splint thearapy

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Oclusal Splint

Cl III Laterognati volunteer group using occlusal stabilization splint before orthognathic surgery

-Splint will be used for at least two months

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No