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CompletedNCT06939179Updated Apr 22, 2025

Effect of Face Mask Therapy on Blood Oxygen Levels

An interventional study of Class III Malocclusion and Class III Malocclusion in Control Patients and Class III Malocclusion, sponsored by Biruni University. Completed at 1 site in Turkey. Open to participants aged 6 Years to 10 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-22.

Sponsored by Biruni University · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 1 year 3 months after the study started (first participant enrolled Jan 2024, registered Apr 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
6 Years to 10 Years
Sex
All
01

Study summary

Skeletal Class III malocclusions are characterized by maxillary retrusion, mandibular protrusion, or a combination of both. In growing individuals presenting with maxillary deficiency, the face mask appliance is widely recognized as one of the most effective and frequently utilized orthopedic interventions. The primary objective of face mask therapy is to stimulate forward and downward growth of the maxilla by disarticulating and activating the circummaxillary sutural system. The application of protraction forces via a face mask results in anterior displacement of the maxillary dentition, accompanied by lingual inclination of the mandibular incisors. Orthopedic effects of the appliance typically include forward and downward movement of the maxilla with a slight degree of upward rotation, posterior dental extrusion, and backward rotation of the mandible. Numerous studies have demonstrated that combining rapid maxillary expansion (RME) with face mask therapy enhances skeletal outcomes, especially when initiated during the early stages of growth. Delayed intervention is often associated with reduced orthopedic responsiveness.

Foersch et al. evaluated the effects of pre-treatment rapid maxillary expansion on face mask therapy outcomes and concluded that expansion positively influences sagittal skeletal changes. In the absence of expansion, greater dental compensation was observed, particularly in the transverse dimension. From a clinical standpoint, anterior crossbite correction can typically be achieved within approximately 3 to 4 months, depending on the severity of the malocclusion. However, establishing a stable overbite and molar relationship usually requires an additional 4 to 6 months of treatment. A prospective clinical study analyzing treatment outcomes in Class III patients reported that overjet correction occurred through 31% maxillary advancement, 21% mandibular retraction, 28% labial proclination of the maxillary incisors, and 20% lingual retroclination of the mandibular incisors. To compensate for potential adverse effects of late mandibular growth, overcorrection of the overjet and molar relationship has been recommended. RME has also been associated with significant anatomical and functional changes in the upper airway. Specifically, an increase in the width of the nasal cavity base leads to a reduction in nasal airway resistance and improvement in nasal respiration. Recent investigations have documented post-treatment increases in pharyngeal airway dimensions and corresponding enhancements in nasal breathing. In a clinical study involving 25 patients with Class III malocclusion due to maxillary deficiency, face mask therapy resulted in a significant increase in nasopharyngeal airway space, which remained stable after a four-year follow-up period. Another study comparing 18 patients treated with RME and face mask therapy against an untreated control group of 163 individuals demonstrated a statistically significant enlargement of the nasopharyngeal space in the treated group. Pulse oximetry operates based on two fundamental physical principles. First, arterial blood generates a pulsatile signal, while non-pulsatile signals originate from venous and capillary beds. Second, modern oximeters utilize light-emitting diodes (LEDs) emitting at wavelengths of 660 nm (red) and 940 nm (infrared), as oxyhemoglobin and deoxygenated hemoglobin display distinct absorption spectra at these wavelengths. In a study conducted by Niaki et al., among patients exhibiting mouth breathing patterns, 65.4% were classified as hypoxemic, while 34.6% had normal oxygen saturation levels. Gender analysis revealed that 31.4% of males and 40% of females demonstrated normal oxygen saturation.Mouth breathing has been shown to influence craniofacial growth and may contribute to the development of various malocclusion patterns. Conversely, specific malocclusion types can exacerbate oral breathing tendencies. It is important to acknowledge that oral respiration has a measurable impact on blood oxygen levels and overall respiratory function.

02

Conditions studied

  • Control Patients
  • Class III Malocclusion

Keywords

  • face mask therapy
  • rapid maxillary expansion
  • orthodontics
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 24 is below the median of 32 across 53 interventional studies indexed under Malocclusion, Angle Class III.

Browse Malocclusion, Angle Class III studies →

Lead sponsor

Biruni University is the lead sponsor of 180 studies on the registry; 45 are open to participants now.

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

04

Who can participate

Ages eligible
6 Years to 10 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

6-10 years of age Class III Malocclusion

Exclusion criteria

-

Exclusion Criteria:

  • +10 years of age
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
24 participants (actual)

Study arms

  • Active comparator
    non treated control group

    The control group was asked about their respiratory tract and quality on the day they were first admitted to our clinic, pulse oximetry measurements will be made and they were called back at the end of 6 months, which is the average face mask treatment period, and this process was repeated.

    Other: Class III Malocclusion

  • Experimental
    face mask with rapid maxillary expansion treated group

    group will be administered a rapid upper jaw expansion protocol with a face mask device and will be asked questions about the airway and its quality. The rapid maxillary expansion appliance applied to this group is bonded hyrax type.

    Other: Class III Malocclusion

  • Experimental
    face mask without rapid maxillary expansion group

    Thisgroup, a bonded appliance without an expansion effect on the upper jaw was designed and applied. A petit-type facemask appliance will be applied with the appliance and respiratory quality will be questioned.

    Other: Class III Malocclusion

Interventions

  • OtherClass III Malocclusion

    Class III malocclusion treatment

  • OtherClass III Malocclusion

    non treated Class III malocclusion

06

What researchers measure

Primary outcomes

  1. examination of oxygen level of Class III malocclusion

    examination of oxygen levels with or without Class III Malocclusion treatment

    Time frame: up to 6 months

07

Study locations

1 site
  • Biruni University
    Istanbul, Turkey
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2024 to primary completion in Jun 2024, 5 months.

Of 37 non-industry interventional studies with no phase under Malocclusion, Angle Class III, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 26. This study's 5 months is below that.

Counting every sponsor, half of 38 studies reached it within 13 months; a quarter within 10 and three quarters within 26.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 15, 2025
First posted
Apr 22, 2025
StartActual
Jan 1, 2024
Primary completionActual
Jun 1, 2024
CompletionActual
Jul 1, 2024
Last update
Apr 22, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06939179
Lead sponsor
Biruni University
Responsible party
Burak Aydin (investigator, Biruni University) — Principal investigator
First posted
Apr 22, 2025
Start date
Jan 1, 2024
Primary completion
Jun 1, 2024
Completion
Jul 1, 2024
Last update
Apr 22, 2025

Oversight

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

Not currently enrolling

This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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