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

NCT05114642 | Completed

• 1 other identifier: 2019/669
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Class III Malocclusion; Hyoid Bone

Keywords

Class III Malocclusion; Craniocervical Posture; Hyoid Bone Position; Pharyngeal Airway

Outcome Measures

Primary Outcomes (3)

• 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.

• 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.

• 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 Outcomes (1)

• 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.

Study Arms (2)

Skeletal Class III Malocclusion Treatment with Face Mask Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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

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.

Also known as: Maxillary expansion

Skeletal Class III Malocclusion Treatment with Face Mask Group

Eligibility Criteria

• Age: 8 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Taner OZTURK, DDS, MS: lead

Study Sites (1)

Erciyes University Faculty of Dentistry

Kayseri, 38039, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 12407940 BACKGROUND

• 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.

  PMID: 30892615 BACKGROUND

• 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.

  PMID: 17906307 BACKGROUND

MeSH Terms

Conditions

Malocclusion, Angle Class III

Interventions

Palatal Expansion Technique

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Orthodontics, Corrective; Orthodontics; Dentistry

Study Officials

• Gokhan Coban, DDS, MDS

  Erciyes University, Faculty of Dentistry, Department of Orthodontics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer

Model Details: Head posture on lateral cephalometric radiographs taken before and after the application of the rapid maxillary expansion device with hooks to the upper dental arch and the Petit type face mask treatment applied after the skeletal class III patients due to maxillary retrognathia, whose growth development continues, for treatment to the Orthodontics Department of the Faculty of Dentistry, cervical posture, pharyngeal airway, and hyoid bone positions are determined.

Study Record Dates

• First Submitted: October 19, 2021
• First Posted: November 10, 2021
• Study Start: November 30, 2019
• Primary Completion: October 30, 2020
• Study Completion: March 30, 2021
• Last Updated: November 10, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)