The Effect of Splint Usage in Laterognathic Cl III Orthognathic Surgery Patients (TMJ)
Primary Purpose
Skeletal Malocclusion, Class III Malocclusion, Laterognathia
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Oclusal Splint
Sponsored by
About this trial
This is an interventional prevention trial for Skeletal Malocclusion
Eligibility Criteria
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
Sites / Locations
- Banu KılıçRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Occlusal stabilization splint
Control
Arm Description
Skeletal class III laterognathia surgery patients who has occlusal stabilization splint thearapy for at least 2 mounths before surgery
Skeletal class III laterognathia surgery patients did not have occlusal stabilization splint thearapy
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05216874
First Posted
January 19, 2022
Last Updated
February 2, 2022
Sponsor
Bezmialem Vakif University
1. Study Identification
Unique Protocol Identification Number
NCT05216874
Brief Title
The Effect of Splint Usage in Laterognathic Cl III Orthognathic Surgery Patients
Acronym
TMJ
Official Title
The Effect of Splint Usage in Laterognathic Cl III Orthognathic Surgery Patients: Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 13, 2022 (Actual)
Primary Completion Date
August 20, 2022 (Anticipated)
Study Completion Date
January 20, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bezmialem Vakif University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skeletal Malocclusion, Class III Malocclusion, Laterognathia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Preoperative occlusal splint treatment Cl III Laterognathia patients
Masking
Participant
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.
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Occlusal stabilization splint
Arm Type
Experimental
Arm Description
Skeletal class III laterognathia surgery patients who has occlusal stabilization splint thearapy for at least 2 mounths before surgery
Arm Title
Control
Arm Type
No Intervention
Arm Description
Skeletal class III laterognathia surgery patients did not have occlusal stabilization splint thearapy
Intervention Type
Device
Intervention Name(s)
Oclusal Splint
Intervention Description
Cl III Laterognati volunteer group using occlusal stabilization splint before orthognathic surgery
-Splint will be used for at least two months
Primary Outcome Measure Information:
Title
MPI Records for Splint Users
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kılıç
Phone
+905322432756
Email
bkilic@bezmialem.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Banu Kılıç, asst. prof
Organizational Affiliation
Bezmialem Vakıf Üniversitesi
Official's Role
Study Director
Facility Information:
Facility Name
Banu Kılıç
City
Fatih
State/Province
İstanbul
ZIP/Postal Code
34093
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Banu Kılıç
Phone
05322432756
Email
bkilic@bezmialem.edu.tr
12. IPD Sharing Statement
Learn more about this trial
The Effect of Splint Usage in Laterognathic Cl III Orthognathic Surgery Patients
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