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

Class III Malocclusion Clinical Trial

— TMJ  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05216874
• Other study ID #: laterognathia MPI
• Status: Recruiting
• Phase: N/A
• Start date: January 13, 2022
• Est. completion date: January 20, 2023

Study information

• Verified date: February 2022
• Source: Bezmialem Vakif University
• Contact: Kiliç
• Phone: +905322432756
• Email: bkilic[@]bezmialem.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: January 20, 2023
• Est. primary completion date: August 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Class III Malocclusion
• Malocclusion
• Malocclusion, Angle Class III
• Prognathism
• Skeletal Malocclusion

Intervention

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

Locations

Country	Name	City	State
Turkey	Banu Kiliç	Fatih	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months