The Effect of Splint Usage in Laterognathic Cl III Orthog... | NCT05216874

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

NCT05216874

Sponsor

Bezmialem Vakif University

Status

Unknown status

Last Update Posted

Feb 3, 2022Actual

Enrollment

48Estimated

Phase

Not Applicable

Conditions

Skeletal Malocclusion
Class III Malocclusion
Laterognathia

Interventions

Oclusal Splint

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 13, 2022Actual

Primary Completion Date

Aug 20, 2022Estimated

Completion Date

Jan 20, 2023Estimated

First Submitted Date

Jan 19, 2022

First Submission Date that Met QC Criteria

Jan 19, 2022

First Posted Date

Feb 1, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 2, 2022

Last Update Posted Date

Feb 3, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Banu Kılıç, Assistant Professor, Bezmialem Vakif UniversityPrincipal Investigator

Lead Sponsor

Bezmialem Vakif UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

48Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Occlusal stabilization splint	Experimental	Skeletal class III laterognathia surgery patients who has occlusal stabilization splint thearapy for at least 2 mounths before surgery	Device: Oclusal Splint
Control	No Intervention	Skeletal class III laterognathia surgery patients did not have occlusal stabilization splint thearapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oclusal Splint	Device	Cl III Laterognati volunteer group using occlusal stabilization splint before orthognathic surgery -Splint will be used for at least two months	Occlusal stabilization splint

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kılıç	Contact	+905322432756		bkilic@bezmialem.edu.tr

Overall Officials

Name	Affiliation	Role
Banu Kılıç, asst. prof	Bezmialem Vakıf Üniversitesi	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Banu Kılıç	Recruiting	Fatih	Istanbul	34093	Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D008313	Malocclusion, Angle Class III

Ancestor Terms

ID	Term
D008310	Malocclusion
D014076	Tooth Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Masking Info

Masking

Single

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.

Who Masked

Participant