- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06939179
Effect of Face Mask Therapy on Blood Oxygen Levels
Evaluation of the Effect of Face Mask Therapy and RPE Application on Blood Oxygen Levels
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Istanbul, Turkey
- Biruni University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
6-10 years of age Class III Malocclusion
-
Exclusion Criteria:
- +10 years of age
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
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Class III malocclusion treatment
non treated Class III malocclusion
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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.
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Class III malocclusion treatment
non treated 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.
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Class III malocclusion treatment
non treated Class III malocclusion
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
examination of oxygen level of Class III malocclusion
Time Frame: up to 6 months
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examination of oxygen levels with or without Class III Malocclusion treatment
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up to 6 months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Musculoskeletal Diseases
- Stomatognathic Diseases
- Jaw Diseases
- Tooth Diseases
- Jaw Abnormalities
- Maxillofacial Abnormalities
- Craniofacial Abnormalities
- Musculoskeletal Abnormalities
- Mandibular Diseases
- Stomatognathic System Abnormalities
- Congenital Abnormalities
- Malocclusion
- Prognathism
- Malocclusion, Angle Class III
Other Study ID Numbers
- 2015-KAEK-77-23-04
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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