The Effect of Orthopedic Face Mask Use on Head Posture and Pharyngeal Airway

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to evaluate the changes in head posture, position of the hyoid bone, pharyngeal airway and cervical posture after the use of Petit type face mask in patients with skeletal class III malocclusion (ANB angle < 0) with ongoing growth. No other study was found in the literature in which head posture, cervical posture, and hyoid bone position were evaluated after the use of a face mask and compared with a control group consisting of patients of the same age group and the same malocclusion.

Detailed Description
-----------------
All radiographic assessments, including cephalometric, pharyngeal airway and craniocervical measurements were performed by the same researcher and she was blind to all the treatment details, orthodontic records, and information of the subjects to prevent bias. Lateral cephalometric radiographs were taken digitally with an X-ray unit (OP300; Instrumentarium Dental, Tuusula, Finland) according to the manufacturer and same technician. Subjects were positioned at the natural head position, teeth in centric occlusion, and lightly closed lips for lateral cephalometric radiographs. Skeletal development of individuals was evaluated using cervical vertebra maturation method (Ref: Bacetti T., An Improved Version of the Cervical Vertebral Maturation (CVM) Method for the Assessment of Mandibular Growth. Angle Orthod.). The skeletal development of individuals was evaluated using the cervical vertebra maturation method and it was determined that all patients were in the prepubertal stage (CS1-CS3). (Ref: Cevidanes L., Comparison of two protocols for maxillary protraction: bone anchors versus face mask with rapid maxillary expansion. Angle Orthod.)

Official Title
-----------------
Evaluation of the Effect of Face Mask Treatment on Head Posture, Pharyngeal Airway, Skeletal and Dental Structures in Patients With Maxillary Retrognathia

Conditions
-----------------
Class III Malocclusion, Hyoid Bone

Intervention / Treatment
-----------------
* Device: Skeletal Class III Malocclusion Treatment with Face Mask Group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: For the study group it is as follows: Patients with skeletal Class III association (ANB < 0°) Maxillary insufficiency patients Patients with ongoing growth development Patients who have used a 'Petit type face mask' for anterior positioning of the maxilla For the control group it is as follows: Patients with skeletal Class III association (ANB < 0°) Maxillary insufficiency patients Patients with ongoing growth development Patients who have not had any orthodontic treatment Exclusion Criteria: Patients with a congenital anomaly or a craniofacial deformity Patients who have undergone orthodontic treatment Patients with tooth extraction or tooth loss Patients with a history of trauma Patients who have completed growth development (patients with Ru on wrist film)

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 10 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Head posture on lateral cephalometric radiographs taken before and after the application of the rapid maxillary expansion device with hooks to the upper dental arch and the Petit type face mask treatment applied after the skeletal class III patients due to maxillary retrognathia, whose growth development continues, for treatment to the Orthodontics Department of the Faculty of Dentistry, cervical posture, pharyngeal airway, and hyoid bone positions are determined.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Skeletal Class III Malocclusion Treatment with Face Mask Group<br>In patients with skeletal class III malocclusion (ANB angle < 0,0) due to maxillary deficiency, rapid maxillary expansion appliances prepared on dental plaster models made of acrylic material covering all the upper dental posterior tooth surfaces were applied before the upper jaw was orthopedically brought forward with a face mask. This process was stopped when the expansion was made so that the palatal tubercles of the maxillary permanent first molars align with the buccal tubercles of the mandibular permanent first molars. Immediately afterwards, the petit-type face mask was applied to the hooks of the maxillary expansion device with the help of elastic bands and used continuously for at least 18 hours a day. After obtaining a positive overjet, the face mask appliance was used at night to ensure retention, and then the treatment was terminated. | Device: Skeletal Class III Malocclusion Treatment with Face Mask Group<br>* Expanding the maxilla, which is narrower than the mandible in the transverse dimension, using a rapid maxillary expansion device and protraction of the maxilla, which is located behind in the sagittal dimension, forward using the face-mask appliance.<br>* Other names: Maxillary expansion;|
| No Intervention: Control Group<br>A control group was formed from patients in the same age group who had skeletal class III malocclusion due to maxillary growth deficiency but were not treated. In this way, the changes that occurred in the normal process in the head, craniocervical postures, pharyngeal airway and hyoid bones of the patients whose growth and development continued could be distinguished. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Craniocervical posture change | Investigation of the change in head posture after treatment of class III malocclusion due to maxillary deficiency with a face mask using craniocervical angles (NSL/CVT, NSL/OPT, CVT/HOR, OPT/HOR, NL/VER, NSL/VER). | Before treatment (T0) and after treatment (up to about 10-12 month; T1) for the study group. First measurement (T0) for the control group and after similar follow-up time (up to about 10-12 month; T1) as for the treatment group. | 
| Pharyngeal airway change | Investigation of the change in pharyngeal airway dimensions after treatment of class III malocclusion due to maxillary deficiency with a face mask using pharyngeal airway sagittal dimension measurements (PNS-UPW, Cv2-MPW, Cv3-LPW, HRL/U-PNS, U-PNS, PASmin). | Before treatment (T0) and after treatment (up to about 10-12 month; T1) for the study group. First measurement (T0) for the control group and after similar follow-up time (up to about 10-12 month; T1) as for the treatment group. | 
| Hyoid bone position change | Investigation of the change in hyoid bone position after treatment of class III malocclusion due to maxillary deficiency with a face mask using hyoid bone location measurements (H-Cv2, H-Cv3, H-Mandibular line, H-Me). | Before treatment (T0) and after treatment (up to about 10-12 month; T1) for the study group. First measurement (T0) for the control group and after similar follow-up time (up to about 10-12 month; T1) as for the treatment group. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of craniocervical posture, pharyngeal airway and hyoid bone change | Investigation of the relationship between changes in craniocervical posture, pharyngeal airway dimensions and hyoid bone position. | Before treatment (T0) and after treatment (up to about 10-12 month; T1) for the study group. First measurement (T0) for the control group and after similar follow-up time (up to about 10-12 month; T1) as for the treatment group. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pharyngeal Airway, Class III Malocclusion, Craniocervical Posture, Hyoid Bone Position