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

NCT ID: NCT05114642

Last Updated: 2021-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-30

Study Completion Date

2021-03-30

Brief Summary

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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

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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.)

Conditions

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Class III Malocclusion Hyoid Bone

Keywords

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Class III Malocclusion Craniocervical Posture Hyoid Bone Position Pharyngeal Airway

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Skeletal Class III Malocclusion Treatment with Face Mask Group

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Maxillary expansion

Eligibility Criteria

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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)
Minimum Eligible Age

8 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taner OZTURK, DDS, MS

OTHER

Sponsor Role lead

Responsible Party

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Taner OZTURK, DDS, MS

Lecturer

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Gokhan Coban, DDS, MDS

Role: PRINCIPAL_INVESTIGATOR

Erciyes University, Faculty of Dentistry, Department of Orthodontics

Locations

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Erciyes University Faculty of Dentistry

Kayseri, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 12407940 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30892615 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17906307 (View on PubMed)

Other Identifiers

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2019/669

Identifier Type: -

Identifier Source: org_study_id