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Clinical Trials/NCT05114642
NCT05114642CompletedNot Applicable

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

Taner OZTURK, DDS, MS2 sites in 1 country60 target enrollmentStarted: November 30, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
60
Locations
2
Primary Endpoint
Hyoid bone position change

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.)

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
8 Years to 10 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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)

Outcomes

Primary Outcomes

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).

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).

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).

Secondary Outcomes

  • 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.)

Investigators

Sponsor
Taner OZTURK, DDS, MS
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Taner OZTURK, DDS, MS

Lecturer

TC Erciyes University

Study Sites (2)

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