Class III MalocclusionNCT05114642

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

A study testing Skeletal Class III Malocclusion Treatment with Face Mask Group in people with Class III Malocclusion and Hyoid Bone, run by Taner OZTURK, DDS, MS at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 8 to 10 years
Conditions the study is for: Class III Malocclusion, Hyoid Bone
What is being tested?: Skeletal Class III Malocclusion Treatment with Face Mask Group
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 30 Nov 2019to 30 Mar 2021
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 8 to 10 years
All sexes
No healthy volunteers
Child

Who may be able to join

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:

Show all 10Show fewer

Patients with skeletal Class III association (ANB < 0°)
Maxillary insufficiency patients
Patients with ongoing growth development
Patients who have not had any orthodontic treatment

Who cannot join

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)

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Erciyes University Faculty of Dentistry
Kayseri, 38039

Other trials in Turkey (Türkiye)

About this study

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

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.)

Conditions: Class III Malocclusion, Hyoid Bone
Being tested: Skeletal Class III Malocclusion Treatment with Face Mask Group
Keywords: Class III Malocclusion, Craniocervical Posture, Hyoid Bone Position, Pharyngeal Airway
Medical subject headings: Malocclusion, Angle Class III

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Skeletal Class III Malocclusion Treatment with Face Mask GroupDevice
Also called Maxillary expansion
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.

Study groups in NCT05114642
Study group	Role	What they receive
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. Receives: 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Nov 201930 Mar 2021

First posted10 Nov 2021
Study start30 Nov 2019
Primary completion30 Oct 2020
Study completion30 Mar 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Class III MalocclusionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: 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.
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05114642
Sponsor's protocol ID: 2019/669
Status last verified: Oct 2021
First submitted: 19 Oct 2021
Last updated: 10 Nov 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Natural History of Craniofacial Anomalies and Developmental Growth Variants
Prognathism, Retrognathism
Not yet recruiting
Treatment of Mandibular Overjet in Children With Maxillary Retrognathism
Maxillary Retrognathism, Children
Recruiting
Comparing 3D-Printed and Milled Titanium Plates in Jaw Surgery (Le Fort I): Accuracy and Operative Time
Malocclusion, Angle Class II, Malocclusion, Angle Class III
Not yet recruiting
3D Printed Occlusal Splints for Intraoperative Use
Malocclusion, Angle Class I, Malocclusion, Angle Class II
Not yet recruiting
Clinical and Radiographic Evaluation of Low Sagittal Medial Ramus Osteotomy for Treatment of Skeletal Class II and Class III Malocclusion
Skeletal Class II Malocclusion, Skeletal Class III Malocclusion

All Class III Malocclusion trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Effect of Face Mask Treatment on Head Posture, Pharyngeal Airway, Skeletal and Dental Structures in Patients With Maxillary Retrognathia
ClinicalTrials.gov ID: NCT05114642
Acronym / sponsor ID: 2019/669
Conditions: Class III Malocclusion, Hyoid Bone
Keywords: Class III Malocclusion, Craniocervical Posture, Hyoid Bone Position, Pharyngeal Airway
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Taner OZTURK, DDS, MSUniversity, hospital or other
Study start: 30 Nov 2019 (actual)
Primary completion: 30 Oct 2020 (actual)
Study completion: 30 Mar 2021 (actual)
First posted: 10 Nov 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: 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.

Arm	Type	Receives
Skeletal Class III Malocclusion Treatment with Face Mask Group	Experimental	Device: Skeletal Class III Malocclusion Treatment with Face Mask GroupIn 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.
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.

Who may qualify

Ages: 8 to 10 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (10 listed)

For the study group it is as follows:
For the control group it is as follows:

Key exclusion criteria (5 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Skeletal Class III Malocclusion Treatment with Face Mask GroupAlso: Maxillary expansionExpanding 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.	Device	Skeletal Class III Malocclusion Treatment with Face Mask Group

Primary outcome

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).
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).
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).

1 secondary outcome

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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2021.
Background: PubMed 12407940Solow 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.
Background: PubMed 30892615Gul 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.
Background: PubMed 17906307Kilinc 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.
Individual participant dataSharing planned: No

Related trials for Class III Malocclusion

RecruitingObservational study
Natural History of Craniofacial Anomalies and Developmental Growth Variants
Prognathism, Retrognathism
Not yet recruiting
Treatment of Mandibular Overjet in Children With Maxillary Retrognathism
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Skeletal Class II Malocclusion, Skeletal Class III Malocclusion

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Gokhan Coban, DDS, MDS principal investigator

Erciyes University, Faculty of Dentistry, Department of Orthodontics

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Skeletal Class III Malocclusion Treatment with Face Mask Group in people with Class III Malocclusion and Hyoid Bone, run by Taner OZTURK, DDS, MS at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05114642, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2021.