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Completed

NCT Number: NCT05114642

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

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.

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Key information

Conditions

Class III Malocclusion Hyoid Bone Malocclusion Malocclusion, Angle Class III Stomatognathic Diseases Tooth Diseases

Age range

8 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erciyes University Faculty of Dentistry

Kayseri, 38039, Turkey (Türkiye)

About this study

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.)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Skeletal Class III Malocclusion Treatment with Face Mask Group

Device

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.

Other names: Maxillary expansion

Primary outcomes

  1. Craniocervical posture change

    Time frame: 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).

  2. Pharyngeal airway change

    Time frame: 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).

  3. Hyoid bone position change

    Time frame: 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).

Secondary outcomes

  1. Correlation of craniocervical posture, pharyngeal airway and hyoid bone change

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Taner OZTURK, DDS, MS

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Nov 10, 2021
Registry last updated
Nov 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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