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

Class III Malocclusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05114642
• Other study ID #: 2019/669
• Status: Completed
• Phase: N/A
• Start date: November 30, 2019
• Est. completion date: March 30, 2021

Study information

• Verified date: October 2021
• Source: TC Erciyes University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 30, 2021
• Est. primary completion date: October 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 10 Years

Eligibility

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)

Related Conditions & MeSH terms

• Class III Malocclusion
• Malocclusion
• Malocclusion, Angle Class III
• Prognathism

Intervention

Device:
• Skeletal Class III Malocclusion Treatment with Face Mask Group
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.

Locations

Country	Name	City	State
Turkey	Erciyes University Faculty of Dentistry	Kayseri

Sponsors (1)

Lead Sponsor	Collaborator
Taner OZTURK, DDS, MS

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Gul Amuk N, Kurt G, Baysal A, Turker G. Changes in pharyngeal airway dimensions following incremental and maximum bite advancement during Herbst-rapid palatal expander appliance therapy in late adolescent and young adult patients: a randomized non-controlled prospective clinical study. Eur J Orthod. 2019 May 24;41(3):322-330. doi: 10.1093/ejo/cjz011. — View Citation

Kilinç AS, Arslan SG, Kama JD, Ozer T, Dari O. Effects on the sagittal pharyngeal dimensions of protraction and rapid palatal expansion in Class III malocclusion subjects. Eur J Orthod. 2008 Feb;30(1):61-6. Epub 2007 Sep 28. — View Citation

Solow B, Sandham A. Cranio-cervical posture: a factor in the development and function of the dentofacial structures. Eur J Orthod. 2002 Oct;24(5):447-56. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	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.