Control PatientsNCT06939179
Effect of Face Mask Therapy on Blood Oxygen Levels
A study testing Class III Malocclusion in people with Control Patients and Class III Malocclusion, run by Biruni University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Control Patients, Class III Malocclusion
- What is being tested?
- Class III Malocclusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 1 Jul 2024
- 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 6 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 6-10 years of age Class III Malocclusion
- -
Who cannot join
- +10 years of age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Control Patients, Class III Malocclusion
- Being tested
- Class III Malocclusion
- Keywords
- face mask therapy, rapid maxillary expansion, orthodontics
- 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.
Class III MalocclusionOther
Class III malocclusion treatment
Class III MalocclusionOther
non treated Class III malocclusion
| Study group | Role | What they receive |
|---|---|---|
| non treated control group | Active comparator | 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. Receives: Other: Class III Malocclusion |
| face mask with rapid maxillary expansion treated group | Experimental | 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. Receives: Other: Class III Malocclusion |
| face mask without rapid maxillary expansion group | Experimental | 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. Receives: Other: Class III Malocclusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
examination of oxygen level of Class III malocclusion
examination of oxygen levels with or without Class III Malocclusion treatment
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start1 Jan 2024
- Primary completion1 Jun 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Control PatientsStudies of the same condition, open and under way.
- More trials run by Biruni UniversityThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In our study, cases were divided into two test groups and one control group. One 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. In the other test group, 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.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.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burak Aydin, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06939179
- Sponsor's protocol ID
- 2015-KAEK-77-23-04
- Status last verified
- Dec 2023
- First submitted
- 15 Apr 2025
- Last updated
- 22 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Face Mask Therapy and RPE Application on Blood Oxygen Levels
- ClinicalTrials.gov ID
- NCT06939179
- Acronym / sponsor ID
- 2015-KAEK-77-23-04
- Conditions
- Control Patients, Class III Malocclusion
- Keywords
- face mask therapy, rapid maxillary expansion, orthodontics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 22 Apr 2025 (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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- In our study, cases were divided into two test groups and one control group. One 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. In the other test group, 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.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.
| Arm | Type | Receives |
|---|---|---|
| non treated control group | Active comparator | Other: Class III MalocclusionThe 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. |
| face mask with rapid maxillary expansion treated group | Experimental | Other: Class III Malocclusiongroup 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. |
| face mask without rapid maxillary expansion group | Experimental | Other: Class III MalocclusionThisgroup, 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. |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 6-10 years of age Class III Malocclusion
- -
Key exclusion criteria (1 listed)
- +10 years of age
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 |
|---|---|---|
| Class III MalocclusionClass III malocclusion treatment | Other | face mask with rapid maxillary expansion treated group, face mask without rapid maxillary expansion group |
| Class III Malocclusionnon treated Class III malocclusion | Other | non treated control group |
Primary outcome
examination of oxygen level of Class III malocclusion
Time frame: up to 6 months
examination of oxygen levels with or without Class III Malocclusion treatment
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 22 Apr 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Class III Malocclusion in people with Control Patients and Class III Malocclusion, run by Biruni University 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 2 inclusion and 1 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 22 Apr 2025. 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?
examination of oxygen level of Class III malocclusion (time frame: up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Apr 2025.