Class II Division 1 Adolescent PatientsNCT06976749
Three-Dimensional Evaluation of Pharyngeal Airway and Facial Dimension Changes in Skeletal Class II Patients Treated With Twin Block Versus Myobrace Appliances
A study testing myobrace appliance and Twin block in people with Class II Division 1 Adolescent Patients, run by University of Baghdad at 1 site in Iraq.
Trial summary
This study is intended primarily to compare the effects of two Class II correction appliances, namely Twin block and Myobrace appliances, on pharyngeal airway dimensions during the treatment of class II division 1 adolescent patients, also evaluates three dimensional (3D) changes of pharyngeal airway including… Read more about this study
- Who is it for?
- Ages 10 to 14 years
- Conditions the study is for
- Class II Division 1 Adolescent Patients
- What is being tested?
- myobrace appliance and Twin block
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIraq
- Study dates
- 20 May 2025to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 10 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age: 10-14 years, at growth spurt phase as determined by the cervical vertebrae maturation stage (C3- C4 ) assessed by lateral cephalograms.
- Skeletal relationship: skeletal class II (ANB angle > 4°) with normal maxilla (SNA angle 78°- 84°), and retrognathic mandible (SNB angle < 77 °).
- Dental relationship: Moderate to severe dental class II division 1 malocclusion with overjet 6 -10 mm.
- Convex facial profile.
- Well aligned/mild crowding (< 4 mm) of dental arches.
- Good to fair oral hygiene status as based on a simplified oral hygiene index (OHI-S).
- Normal or decreased lower facial height (SN-MP angle ≤ 32).
Who cannot join
- Previous orthodontic/orthopedic treatment.
- Patients with dental open bite
- Patients with obvious facial asymmetry.
- Patients with orofacial cleft.
- Previous extractions.
- Presence of mandibular shifts.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
This study is intended primarily to compare the effects of two Class II correction appliances, namely Twin block and Myobrace appliances, on pharyngeal airway dimensions during the treatment of class II division 1 adolescent patients, also evaluates three dimensional (3D) changes of pharyngeal airway including: minimum cross-sectional area and volume using Cone Beam Computed Tomography (CBCT), skeletal, dentoalveolar, and soft tissue changes using cephalometric analysis, and three dimensional (3D) soft tissue changes using facial scans. The hypothesis being a consideration of no significant difference in the changes of pharyngeal airway and facial dimensions in skeletal class II patients before and after treatment with Twin block and Myobrace.
Read the detailed description
This study is a multicenter randomized comparative clinical trial, employing non-stratified randomization in two-parallel arms with equal allocation ratio of 1:1. Patients will be recruited from Orthodontic Clinic at the College of Dentistry, University of Kufa, and from specialized dental centers affiliated to the Iraqi Ministry of Health, in addition to some private clinics. Initially, the patients will be assessed for eligibility to participate in the study according to the inclusion criteria. Then, the parents will be informed verbally about the purpose of the study and will be provided with the informed consent form to be signed. Patients will be treated using two types of functional appliances ( Twin Block and Myobrace) for six months. Regular follow-ups will be conducted during the course of the treatment and progress will be charted out at 4-weeks intervals.
Participants will be randomly assigned to one of two groups, each receiving one of the specified treatments over a six-month period.
Group I: Twin Block Appliance
- Design: Comprises maxillary and mandibular components anchored using Adams' clasps on the first permanent molars and lower first premolars. A passive labial bow will be incorporated into the upper arch, with ball-end clasps for additional retention.
- Bite Registration: Achieved through a symmetric protrusive bite using modeling wax, ensuring an edge-to-edge incisal relationship with a 2-3 mm bite opening between central incisors.
- Inclined Bite Blocks: Positioned at a 70° angle to facilitate forward mandibular displacement.
- Patient Instructions: Continuous wear is mandated (24 hours/day), excluding periods of oral hygiene. Adjustments using self-cured acrylic may be made for further mandibular advancement.
Group II: Myobrace Appliance
- Selection: Appropriate sizing determined by measuring the inter-canine distance using a specialized ruler.
- Fitting: Ensures alignment of upper canines within designated slots, matching the appliance's midline with the dental midline.
- Wear Protocol:
- Week 1: Gradual increase in daytime wear duration.
- Week 2 Onwards: Overnight wear targeting at least 8 hours.
- Post Week 4: Combination of 1-2 hours daytime wear plus overnight usage.
- Supplementary Activities: Incorporates exercises targeting breathing habits, tongue positioning, swallowing patterns, and lip function.
Imaging Protocols:
- Cone Beam Computed Tomography (CBCT):
- Timing: Conducted pre-treatment and at end of study .
- Positioning: Subjects seated upright with the Frankfort horizontal plane parallel to the floor, maintaining natural occlusion, relaxed lips, and resting tongue posture.
- Parameters: Scans performed using the Morita Veraview X 800 device (100 kV tube voltage, 3 mA tube current, 14 x 15 cm field of view, 0.08 mm voxel size, 18-second scan time). three dimensional (3D) Facial Scanning:
- Equipment: Utilizes an iPhone Pro 14 equipped with the 3D Scanner App™.
- Landmark Identification: Seventeen specific facial landmarks will be marked using black eyeliner to ensure consistency.
- Participant Positioning: Subjects will be seated in a relaxed posture with a natural head position under standardized lighting conditions.
- Pre-Scan Preparations: Removal of glasses, jewelry, and use of hairbands to minimize obstructions.
- Data Processing: Captured three dimensional (3D)facial models will be exported as Standard Tessellation Language (STL) files and analyzed using Blender 3.6 LTS software for linear and angular measurements.
Data Analysis:
- three dimensional (3D) Model Reconstruction: CBCT data will be processed using ProPlan CMF 3.0 (Materialise) software.
- Segmentation: Hard tissues and upper airway structures will be delineated based on specific Hounsfield Unit (HU) thresholds.
- Pharyngeal Airway Segmentation: Divided into nasopharynx, velopharynx, glossopharynx, and hypopharynx, with precise anatomical boundaries defined for each segment.
Measurements:
- Airway Analysis: Assessment of minimum cross-sectional area, total airway volume, and pharyngeal airway length.
- Soft Tissue Evaluation: Linear and angular anthropometric measurements derived from 3D facial scans.
- Conditions
- Class II Division 1 Adolescent Patients
- Being tested
- myobrace appliance, Twin block
- Keywords
- class II division 1 malocclusion, mandibular retrognathism, retrognathic mandible, Pharyngeal Airway, Twin block, Myobrace, Three-Dimensional Evaluation, facial scan
- Medical subject headings
- Malocclusion, Angle Class II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
myobrace applianceDevice
functional appliance
Twin blockDevice
functional appliance
| Study group | Role | What they receive |
|---|---|---|
| Twin block appliance | Experimental | It consists of maxillary and mandibular appliances that fit tightly against the teeth, alveolus, and adjacent supporting structures. Adams' clasps will be used bilaterally to anchor them to the first permanent molars and lower first premolars. A short passive labial bow will be added to the upper arch and ball end clasps to the interproximal areas of the lower arch for retention. The appliance will be fabricated after a symmetric protrusive bite registration using pink modeling wax sheets, in which the patients will rehearse many times before registration. The inclined bite blocks (ramps) will be at 70 which acts as a guiding mechanism for forward displacement of the mandible. The working bite will be taken with the incisors in an edge-to-edge relationship if possible and 2 to 3 mm bite opening between the central incisors. All the subjects will be instructed to wear the appliance 24 hours/day except for brushing. If further advancement Receives: Device: Twin block |
| Myobrace appliance | Experimental | The appropriate size of Myobrace is chosen by using a special ruler to measure the distance between the distal portion of the lateral upper right incisor and the left, regardless of any crowding or diastema. The measure is based on the mesial-distal dimensions of the upper incisors, and not on their position. This distance is used to determine the correct size using a special table. Once chosen and inserted in patient's mouth, upper canines, even if not yet erupted, must be in their slots, so that the dental mildines coincided with the appliance's midline. In the first week, the patients will be instructed to gradually increase the wearing time of the appliance during the daytime. By the start of the second week, the patients will be instructed to wear the appliance achieving at least 8 hours during sleeping. By the end of the first 4 weeks, the patients will wear the appliances minimum of 1- 2 hours during the day plus the overnig Receives: Device: myobrace appliance |
What is being measured
The primary outcome is the main question the study is designed to answer.
minimum cross-sectional area of the pharyngeal airway in (mm^2) using Cone Beam Computed Tomography (CBCT)
3D measurements of pharyngeal airway minimum cross-sectional (mm^2) will be performed for all participants of both groups at two stages before treatment and at the end of the study using CBCT
Measured: From enrollment to the end of treatment at 6 months
Secondary outcomes (6)
three dimensional changes in the volume of the pharyngeal airway using CBCT
- pharyngeal airway volume in (mm^3) using CBCT.
Measured: From enrollment to the end of treatment at 6 months
Skeletal changes using cephalometric analysis
- SNA angle (relative anteroposterior position of maxilla to anterior cranial base).
- SNB angle (relative anteroposterior position of mandible to anterior cranial base).
- ANB angle (relative anteroposterior position of maxilla to mandible).
- SN-Pog angle (relative anteroposterior position of chin to anterior cranial base).
- PP-MP (Angle between palatal and mandibular plane).
- SN-MP (Angle between SN and mandibular plane).
- Ar-Go-Me ((Gonial Angle, it refers to the relation between the body of the mandible and the ramus).
Measured: From enrollment to the end of treatment at 6 months
Soft tissue changes using cephalometric analysis
- NL angle (nasolabial angle).
- U Lip-E line (upper lip to Rickett's Esthetic line).
- L Lip-E Line (lower lip to Rickett's Esthetic line).
Measured: From enrollment to the end of treatment at 6 months
Dentoalveolar changes using cephalometric analysis
- U1-PP (upper incisor inclination to the palatal plane).
- L1-MP (lower incisor inclination to the mandibular plane).
Measured: From enrollment to the end of treatment at 6 months
Dental changes using study models
overjet, overbite, inter canine, inter premolar, and inter molar widths in (mm)
Measured: From enrollment to the end of treatment at 6 months
three dimentional soft tissue changes using facial scans
Total face height (mm) Upper anterior face height (mm) Lower anterior face height (mm) Bigonial width (mm) Mandibular length (mm) Soft tissue convexity angle Total face convexity angle Gonial angle Alar base width (mm) Lip width (mm) Nasolabial angle Labiomental angle
Measured: From enrollment to the end of treatment at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start20 May 2025 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Class II Division 1 Adolescent PatientsStudies of the same condition, open and under way.
- More trials run by University of BaghdadThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- two-parallel arms with equal allocation ratio of 1:1
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lubna Makki Hussein, University of Baghdad
- Investigators
- Lubna M Hussein, B.D.S., M.Sc. (Orthodontics), Principal investigator, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06976749
- Sponsor's protocol ID
- 1033425
- Status last verified
- May 2025
- First submitted
- 19 Mar 2025
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) will be shared, including 3D facial scans, CBCT airway volume measurements, and linear and angular facial measurements. The shared data will not contain any personally identifiable information. Data will be made available upon reasonable request for research purposes related to orthodontic treatment, airway evaluation, and facial growth analysis. Access will be granted to qualified researchers through a data-sharing agreement, ensuring compliance with ethical guidelines and patient privacy regulations.
Publications
Kim SS, Kim YI, Park SB, Kim SH. Three-dimensional evaluation of the pharyngeal airway space in patients with anterior open bite. Korean J Orthod. 2023 Nov 25;53(6):358-364. doi: 10.4041/kjod22.187. Epub 2023 Jan 31.
PubMed 36718119
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three-Dimensional Evaluation of Pharyngeal Airway and Facial Dimension Changes in Skeletal Class II Patients Treated With Twin Block Versus Myobrace Appliances
- ClinicalTrials.gov ID
- NCT06976749
- Acronym / sponsor ID
- 1033425
- Conditions
- Class II Division 1 Adolescent Patients
- Keywords
- class II division 1 malocclusion, mandibular retrognathism, retrognathic mandible, Pharyngeal Airway, Twin block, Myobrace, Three-Dimensional Evaluation, facial scan
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 20 May 2025 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 16 May 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.
This study is intended primarily to compare the effects of two Class II correction appliances, namely Twin block and Myobrace appliances, on pharyngeal airway dimensions during the treatment of class II division 1 adolescent patients, also evaluates three dimensional (3D) changes of pharyngeal airway including: minimum cross-sectional area and volume using Cone Beam Computed Tomography (CBCT), skeletal, dentoalveolar, and soft tissue changes using cephalometric analysis, and three dimensional (3D) soft tissue changes using facial scans. The hypothesis being a consideration of no significant difference in the changes of pharyngeal airway and facial dimensions in skeletal class II patients before and after treatment with Twin block and Myobrace.
Detailed description
This study is a multicenter randomized comparative clinical trial, employing non-stratified randomization in two-parallel arms with equal allocation ratio of 1:1. Patients will be recruited from Orthodontic Clinic at the College of Dentistry, University of Kufa, and from specialized dental centers affiliated to the Iraqi Ministry of Health, in addition to some private clinics. Initially, the patients will be assessed for eligibility to participate in the study according to the inclusion criteria. Then, the parents will be informed verbally about the purpose of the study and will be provided with the informed consent form to be signed. Patients will be treated using two types of functional appliances ( Twin Block and Myobrace) for six months. Regular follow-ups will be conducted during the course of the treatment and progress will be charted out at 4-weeks intervals.
Participants will be randomly assigned to one of two groups, each receiving one of the specified treatments over a six-month period.
Group I: Twin Block Appliance
- Design: Comprises maxillary and mandibular components anchored using Adams' clasps on the first permanent molars and lower first premolars. A passive labial bow will be incorporated into the upper arch, with ball-end clasps for additional retention.
- Bite Registration: Achieved through a symmetric protrusive bite using modeling wax, ensuring an edge-to-edge incisal relationship with a 2-3 mm bite opening between central incisors.
- Inclined Bite Blocks: Positioned at a 70° angle to facilitate forward mandibular displacement.
- Patient Instructions: Continuous wear is mandated (24 hours/day), excluding periods of oral hygiene. Adjustments using self-cured acrylic may be made for further mandibular advancement.
Group II: Myobrace Appliance
- Selection: Appropriate sizing determined by measuring the inter-canine distance using a specialized ruler.
- Fitting: Ensures alignment of upper canines within designated slots, matching the appliance's midline with the dental midline.
- Wear Protocol:
- Week 1: Gradual increase in daytime wear duration.
- Week 2 Onwards: Overnight wear targeting at least 8 hours.
- Post Week 4: Combination of 1-2 hours daytime wear plus overnight usage.
- Supplementary Activities: Incorporates exercises targeting breathing habits, tongue positioning, swallowing patterns, and lip function.
Imaging Protocols:
- Cone Beam Computed Tomography (CBCT):
- Timing: Conducted pre-treatment and at end of study .
- Positioning: Subjects seated upright with the Frankfort horizontal plane parallel to the floor, maintaining natural occlusion, relaxed lips, and resting tongue posture.
- Parameters: Scans performed using the Morita Veraview X 800 device (100 kV tube voltage, 3 mA tube current, 14 x 15 cm field of view, 0.08 mm voxel size, 18-second scan time). three dimensional (3D) Facial Scanning:
- Equipment: Utilizes an iPhone Pro 14 equipped with the 3D Scanner App™.
- Landmark Identification: Seventeen specific facial landmarks will be marked using black eyeliner to ensure consistency.
- Participant Positioning: Subjects will be seated in a relaxed posture with a natural head position under standardized lighting conditions.
- Pre-Scan Preparations: Removal of glasses, jewelry, and use of hairbands to minimize obstructions.
- Data Processing: Captured three dimensional (3D)facial models will be exported as Standard Tessellation Language (STL) files and analyzed using Blender 3.6 LTS software for linear and angular measurements.
Data Analysis:
- three dimensional (3D) Model Reconstruction: CBCT data will be processed using ProPlan CMF 3.0 (Materialise) software.
- Segmentation: Hard tissues and upper airway structures will be delineated based on specific Hounsfield Unit (HU) thresholds.
- Pharyngeal Airway Segmentation: Divided into nasopharynx, velopharynx, glossopharynx, and hypopharynx, with precise anatomical boundaries defined for each segment.
Measurements:
- Airway Analysis: Assessment of minimum cross-sectional area, total airway volume, and pharyngeal airway length.
- Soft Tissue Evaluation: Linear and angular anthropometric measurements derived from 3D facial scans.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- two-parallel arms with equal allocation ratio of 1:1
| Arm | Type | Receives |
|---|---|---|
| Twin block appliance | Experimental | Device: Twin blockIt consists of maxillary and mandibular appliances that fit tightly against the teeth, alveolus, and adjacent supporting structures. Adams' clasps will be used bilaterally to anchor them to the first permanent molars and lower first premolars. A short passive labial bow will be added to the upper arch and ball end clasps to the interproximal areas of the lower arch for retention. The appliance will be fabricated after a symmetric protrusive bite registration using pink modeling wax sheets, in which the patients will rehearse many times before registration. The inclined bite blocks (ramps) will be at 70 which acts as a guiding mechanism for forward displacement of the mandible. The working bite will be taken with the incisors in an edge-to-edge relationship if possible and 2 to 3 mm bite opening between the central incisors. All the subjects will be instructed to wear the appliance 24 hours/day except for brushing. If further advancement |
| Myobrace appliance | Experimental | Device: myobrace applianceThe appropriate size of Myobrace is chosen by using a special ruler to measure the distance between the distal portion of the lateral upper right incisor and the left, regardless of any crowding or diastema. The measure is based on the mesial-distal dimensions of the upper incisors, and not on their position. This distance is used to determine the correct size using a special table. Once chosen and inserted in patient's mouth, upper canines, even if not yet erupted, must be in their slots, so that the dental mildines coincided with the appliance's midline. In the first week, the patients will be instructed to gradually increase the wearing time of the appliance during the daytime. By the start of the second week, the patients will be instructed to wear the appliance achieving at least 8 hours during sleeping. By the end of the first 4 weeks, the patients will wear the appliances minimum of 1- 2 hours during the day plus the overnig |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Age: 10-14 years, at growth spurt phase as determined by the cervical vertebrae maturation stage (C3- C4 ) assessed by lateral cephalograms.
- Skeletal relationship: skeletal class II (ANB angle > 4°) with normal maxilla (SNA angle 78°- 84°), and retrognathic mandible (SNB angle < 77 °).
- Dental relationship: Moderate to severe dental class II division 1 malocclusion with overjet 6 -10 mm.
- Convex facial profile.
- Well aligned/mild crowding (< 4 mm) of dental arches.
Key exclusion criteria (6 listed)
- Previous orthodontic/orthopedic treatment.
- Patients with dental open bite
- Patients with obvious facial asymmetry.
- Patients with orofacial cleft.
- Previous extractions.
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 |
|---|---|---|
| myobrace appliancefunctional appliance | Device | Myobrace appliance |
| Twin blockfunctional appliance | Device | Twin block appliance |
Primary outcome
minimum cross-sectional area of the pharyngeal airway in (mm^2) using Cone Beam Computed Tomography (CBCT)
Time frame: From enrollment to the end of treatment at 6 months
3D measurements of pharyngeal airway minimum cross-sectional (mm^2) will be performed for all participants of both groups at two stages before treatment and at the end of the study using CBCT
6 secondary outcomes
three dimensional changes in the volume of the pharyngeal airway using CBCT
Time frame: From enrollment to the end of treatment at 6 months
Skeletal changes using cephalometric analysis
Time frame: From enrollment to the end of treatment at 6 months
Soft tissue changes using cephalometric analysis
Time frame: From enrollment to the end of treatment at 6 months
Dentoalveolar changes using cephalometric analysis
Time frame: From enrollment to the end of treatment at 6 months
Dental changes using study models
Time frame: From enrollment to the end of treatment at 6 months
three dimentional soft tissue changes using facial scans
Time frame: From enrollment to the end of treatment at 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Background: PubMed 36718119Kim SS, Kim YI, Park SB, Kim SH. Three-dimensional evaluation of the pharyngeal airway space in patients with anterior open bite. Korean J Orthod. 2023 Nov 25;53(6):358-364. doi: 10.4041/kjod22.187. Epub 2023 Jan 31.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) will be shared, including 3D facial scans, CBCT airway volume measurements, and linear and angular facial measurements. The shared data will not contain any personally identifiable information. Data will be made available upon reasonable request for research purposes related to orthodontic treatment, airway evaluation, and facial growth analysis. Access will be granted to qualified researchers through a data-sharing agreement, ensuring compliance with ethical guidelines and patient privacy regulations.
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.
Lubna M Hussein, B.D.S., M.Sc. (Orthodontics) principal investigator
University of Baghdad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing myobrace appliance and Twin block in people with Class II Division 1 Adolescent Patients, run by University of Baghdad at 1 site in Iraq.
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 7 inclusion and 6 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: enrolling by invitation, as of the sponsor's last update on 16 May 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 Iraq. 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?
This study is still under way. Results are not available in the source record yet.
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?
minimum cross-sectional area of the pharyngeal airway in (mm^2) using Cone Beam Computed Tomography (CBCT) (time frame: From enrollment to the end of treatment at 6 months). 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 NCT06976749, which also lists 1 linked publication.
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 16 May 2025.