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

NCT05216874 | Unknown DMC

• 1 other identifier: laterognathia MPI
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Skeletal Malocclusion; Class III Malocclusion; Laterognathia

Outcome Measures

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.

  12 months

Study Arms (2)

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Banu Kılıç

Fatih, Istanbul, 34093, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Malocclusion, Angle Class III

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Banu Kılıç, asst. prof

  Bezmialem Vakıf Üniversitesi

  STUDY DIRECTOR

Central Study Contacts

Kılıç

CONTACT

+905322432756; bkilic@bezmialem.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Preoperative occlusal splint treatment Cl III Laterognathia patients

Study Record Dates

• First Submitted: January 19, 2022
• First Posted: February 1, 2022
• Study Start: January 13, 2022
• Primary Completion: August 20, 2022
• Study Completion: January 20, 2023
• Last Updated: February 3, 2022

Record last verified: 2022-02

Locations

TU (1)