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

Not Applicable

• Conditions: Laterognathia; Skeletal Malocclusion; Class III Malocclusion
• Interventions: Device: Oclusal Splint

• Registration Number: NCT05216874
• Lead Sponsor: Bezmialem Vakif University

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.

Study Timeline

• Study Start: 2022-01-13
• Study First Submitted: 2022-01-19
• Study First Submitted QC: 2022-01-19
• Status Verified: 2022-02
• Study First Posted: 2022-02-01
• Last Update Submitted: 2022-02-02
• Last Update Posted: 2022-02-03
• Primary Completion: 2022-08-20
• Study Completion: 2023-01-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Occlusal stabilization splint	Oclusal Splint	Skeletal class III laterognathia surgery patients who has occlusal stabilization splint thearapy for at least 2 mounths before surgery

Primary Outcome Measures

Name	Time	Method
MPI Records for Splint Users	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.

Trial Locations

Locations (1)

Banu Kılıç; 🇹🇷 Fatih, İstanbul, Turkey