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CompletedNCT05114642Updated Nov 10, 2021

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

An interventional study of Skeletal Class III Malocclusion Treatment with Face Mask Group in Class III Malocclusion and Hyoid Bone, sponsored by Taner OZTURK, DDS, MS. Completed at 1 site in Turkey. Open to participants aged 8 Years to 10 Years. Per ClinicalTrials.gov, last updated 2021-11-10.

Sponsored by Taner OZTURK, DDS, MS · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 10 months after the study started (first participant enrolled Nov 2019, registered Oct 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
8 Years to 10 Years
Sex
All
01

Study 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.

Read the 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.)

02

Conditions studied

  • Class III Malocclusion
  • Hyoid Bone

Keywords

  • Class III Malocclusion
  • Craniocervical Posture
  • Hyoid Bone Position
  • Pharyngeal Airway
03

In context

Malocclusion, Angle Class III

57 studies on the registry are indexed under Malocclusion, Angle Class III; 11 are open to participants now.

This study's enrollment of 60 is above the median of 32 across 53 interventional studies indexed under Malocclusion, Angle Class III.

Browse Malocclusion, Angle Class III studies →

Lead sponsor

Taner OZTURK, DDS, MS is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years to 10 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    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.

    Device: Skeletal Class III Malocclusion Treatment with Face Mask Group

  • No intervention
    Control Group

    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.

Interventions

  • DeviceSkeletal 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.

    Also known as: Maxillary expansion

06

What researchers measure

Primary outcomes

  1. 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).

    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.

  2. 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).

    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.

  3. 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).

    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.

Secondary outcomes

  1. 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.

    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.

07

Study locations

1 site
  • Erciyes University Faculty of Dentistry
    Kayseri, 38039, Turkey
08

References and documents

Publications

  • 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. doi: 10.1093/ejo/24.5.447. PubMed 12407940 ↗
  • 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. PubMed 30892615 ↗
  • Kilinc 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. doi: 10.1093/ejo/cjm076. Epub 2007 Sep 28. PubMed 17906307 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 10, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05114642
Lead sponsor
Taner OZTURK, DDS, MS
Responsible party
Taner OZTURK, DDS, MS (Lecturer, TC Erciyes University) — Sponsor-investigator
First posted
Nov 10, 2021
Start date
Nov 30, 2019
Primary completion
Oct 30, 2020
Completion
Mar 30, 2021
Last update
Nov 10, 2021

Study contacts

Gokhan Coban, DDS, MDS
principal investigator · Erciyes University, Faculty of Dentistry, Department of Orthodontics

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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