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

Not Applicable

Completed

• Conditions: Hyoid Bone; Class III Malocclusion
• Interventions: Device: Skeletal Class III Malocclusion Treatment with Face Mask Group

• Registration Number: NCT05114642
• Lead Sponsor: Taner OZTURK, DDS, MS

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.)

Study Timeline

• Study Start: 2019-11-30
• Primary Completion: 2020-10-30
• Study Completion: 2021-03-30
• Status Verified: 2021-10
• Study First Submitted: 2021-10-19
• Study First Submitted QC: 2021-10-29
• Last Update Submitted: 2021-10-29
• Study First Posted: 2021-11-10
• Last Update Posted: 2021-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• For the study group it is as follows:

  1. Patients with skeletal Class III association (ANB < 0°)
  2. Maxillary insufficiency patients
  3. Patients with ongoing growth development
  4. Patients who have used a 'Petit type face mask' for anterior positioning of the maxilla

• For the control group it is as follows:

  1. Patients with skeletal Class III association (ANB < 0°)
  2. Maxillary insufficiency patients
  3. Patients with ongoing growth development
  4. Patients who have not had any orthodontic treatment

Exclusion Criteria

1. Patients with a congenital anomaly or a craniofacial deformity
2. Patients who have undergone orthodontic treatment
3. Patients with tooth extraction or tooth loss
4. Patients with a history of trauma
5. Patients who have completed growth development (patients with Ru on wrist film)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Skeletal Class III Malocclusion Treatment with Face Mask Group	Skeletal Class III Malocclusion Treatment with Face Mask Group	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.

Primary Outcome Measures

Name	Time	Method
Hyoid bone position change	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.	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).
Pharyngeal airway change	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.	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).
Craniocervical posture change	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.	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).

Secondary Outcome Measures

Name	Time	Method
Correlation of craniocervical posture, pharyngeal airway and hyoid bone change	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.	Investigation of the relationship between changes in craniocervical posture, pharyngeal airway dimensions and hyoid bone position.

Trial Locations

Locations (1)

Erciyes University Faculty of Dentistry; 🇹🇷 Kayseri, Turkey