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Status unknownNCT05216874TMJUpdated Feb 3, 2022

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

An interventional study of Oclusal Splint in Skeletal Malocclusion, Class III Malocclusion and Laterognathia, sponsored by Bezmialem Vakif University. Status unknown at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-03.

Sponsored by Bezmialem Vakif University · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Feb 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Skeletal Malocclusion
  • Class III Malocclusion
  • Laterognathia
03

In context

Malocclusion, Angle Class III

57 studies on the registry are indexed under Malocclusion, Angle Class III; 11 are open to participants now.

This study's planned enrollment of 48 is above the median of 32 across 53 interventional studies indexed under Malocclusion, Angle Class III.

Browse Malocclusion, Angle Class III studies →

Lead sponsor

Bezmialem Vakif University is the lead sponsor of 354 studies on the registry; 59 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
48 participants (estimated)

Study arms

  • Experimental
    Occlusal stabilization splint

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

    Device: Oclusal Splint

  • No intervention
    Control

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

Interventions

  • DeviceOclusal Splint

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 12 months

07

Study locations

1 of 1 sites recruiting
  • Banu Kılıç
    Fatih, İstanbul 34093, Turkey
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 3, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05216874
Responsible party
Banu Kılıç (Assistant Professor, Bezmialem Vakif University) — Principal investigator
First posted
Feb 1, 2022
Start date
Jan 13, 2022
Primary completion
Aug 20, 2022 (estimated)
Completion
Jan 20, 2023 (estimated)
Last update
Feb 3, 2022

Study contacts

Kılıç
Contact
bkilic@bezmialem.edu.tr
+905322432756
Banu Kılıç, asst. prof
study director · Bezmialem Vakıf Üniversitesi

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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