Skeletal Class III MalocclusionNCT07703007
Skeletal and Dentoalveolar Effects of Functional Clear Aligner Therapy in Growing Patient With Skeletal Class III Malocclusion
A study testing Functional Clear Aligner in people with Skeletal Class III Malocclusion, run by Mansoura University at 1 site in Egypt.
Trial summary
The purpose of this study is to evaluate the skeletal, dentoalveolar \& soft tissue effects of functional clear aligner therapy in growing patient with Skeletal class III malocclusion. Read more about this study
- Who is it for?
- Ages 8 to 11 years
- Conditions the study is for
- Skeletal Class III Malocclusion
- What is being tested?
- Functional Clear Aligner
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Feb 2026to 13 Jul 2027
- 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 8 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients' age (8-11) years (CVM stages 2-3)
- Mild class III skeletal pattern (Wits appraisal = 0 to -8)
- Mild to moderate reverse overjet (-1 to -4)
- Overbite (1-5)
- Growing patients
- Average or below average maxillary-mandibular plane angle and lower facial height
- Mild incisors compensations
Who cannot join
- Severe class III skeletal pattern
- Long facial height
- Bad oral hygiene
- Systemic condition that may interfere with treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Faculty of Dentistry, Mansoura University
Al Mansurah, Dakahlia Governorate
About this study
The purpose of this study is to evaluate the skeletal, dentoalveolar \& soft tissue effects of functional clear aligner therapy in growing patient with Skeletal class III malocclusion. Skeletal class III discrepancy has been a therapeutic challenge due to the fact that its therapeutic management seeks not only the correction of the malocclusion but also the aesthetic component of the patient which is affected according to the severity of the discrepancy. Early diagnosis, planning of adequate therapeutic time and choice of devices to correct malocclusion are the essential keys to successful management of class III in all its forms. Functional appliances are commonly used for the treatment of skeletal class III malocclusion. Removable aesthetic appliance therapy as clear aligner becomes an increasingly common addition to the orthodontic armamentarium. It offers certain advantages over traditional appliance orthodontic treatments; these include fewer clinical emergencies and improved aesthetics, comfort, oral hygiene, periodontal health, and lack of soft tissue irritation. The aim of this study is to evaluate the skeletal, dentoalveolar \& soft tissue effects of functional clear aligner therapy in growing patient with Skeletal class III malocclusion. A total of four blocks are digitally designed, with two blocks placed in the maxillary aligner in the anterior region and two blocks placed in the mandibular aligner in the posterior region. The blocks are designed as inclined planes to guide mandibular repositioning, simulating the reverse twin block mechanism. The upper and lower bite blocks are designed to interact with each other through coherent, specifically designed 70° inclined planes, allowing controlled mandibular repositioning during occlusal contact. Optimized attachments are digitally placed on selected teeth to enhance aligner retention and control tooth movement. Oral Health Related Quality of Life (OHRQoL) assessments will be incorporated as an outcome measure in addressing and measuring clinically meaningful change.
Read the detailed description
. Fifteen patients with mild skeletal class III were selected according to specific inclusion criteria and included in the study, these patients were treated with Functional Clear Aligner to evaluate its skeletal, dentoalveolar \& soft tissue effects.
Bite registration: The patient intraoral scan will be performed according to the constructor's instructions. The software interface of the intra-oral scanner allows the registration of two different maxillo-mandibular relationships (MMRs).The first MMR scan will be registered in maximum intercuspation occlusion. The second scan will be registered in planned mandibular retrusion for Aesthetic functional appliance design. Bite registration will be done with the mandible in the most retruded position with an inter- incisal clearance of 2 mm and a clearance of 6 mm in the posterior segment.
To obtain an optimal and reproducible MMR scan in mandibular retrusion, curable resin will be used as a bite registration material. Two pieces of resin will be used as bite registration material, placing them (one piece per each side of the dentition) onto the occlusal surface of the posterior dentition. Then mandible will be guided in the most retruded position, this will be performed with a brief preliminary patient training. When the mandible reaches the desired backward position, the occlusal resin will be cured on both sides. Then the two registration pieces of resin will be fully cured outside of the mouth.
Once fully polymerized they will be checked for integrity, and they will be placed in occlusion to check that final mandibular retrusion is adequate and conforms to planned retrusion. Subsequently, patient maxillo-mandibular relationship in mandibular retrusion will be scanned.
During MMR scan acquisition on the right side, only the left piece of resin will be used to maintain mandibular retrusion. Conversely, during MMR scan acquisition on the left side, only the right piece of resin will be used. At the end of the MMR acquisition process, the software will be able to reorient the maxillary and mandibular scan according to the MMR.
Appliance construction: The steps of appliance construction are as follows:
- Import of Digital Scans Digital intraoral scans of the maxillary and mandibular arches are imported into the orthodontic planning software.
- Software Planning and Treatment Setup All software planning steps are performed, including model alignment, occlusal setup, and registration of the construction bite.
- Placement of Attachments Optimized attachments are digitally placed on selected teeth to enhance aligner retention and control tooth movement.
- Design of Mandibular Advancement Blocks A second design phase is performed to incorporate the mandibular advancement blocks. A total of four blocks are digitally designed, with two blocks placed in the maxillary aligner in the anterior region and two blocks placed in the mandibular aligner in the posterior region. The blocks are designed as inclined planes to guide mandibular repositioning, simulating the reverse twin block mechanism. The upper and lower bite blocks are designed to interact with each other through coherent, specifically designed 70° inclined planes, allowing controlled mandibular repositioning during occlusal contact. After the design process, the generated three-dimensional models are exported as files with STL extension and produced using different procedures according to their specific purposes.
- 3D Printing of Aligner Models The finalized digital files are used for three-dimensional printing of the aligner models.
- Thermoforming of Clear Aligners Clear aligners are fabricated by thermoforming thermoplastic sheets over the printed models.
The appliance construction workflow, including digital scanning, virtual treatment planning, attachment design, mandibular advancement block construction, STL file export, three-dimensional printing, and thermoforming of clear aligners, was performed according to previously described digital orthodontic and clear aligner protocols.
Clinical application:
- Bonding of Attachments Composite attachments are bonded on the facial surface of upper and lower central incisors and the upper and lower first permanent molars according to the digitally planned attachment design: Intra-oral bonding procedure will be started with the etching of the facial surface of the maxillary and mandibular central incisors and first permanent molars with (Meta Etchant) for 15-20 seconds. Etched dental surfaces will be washed and dried with chair air-flow and light-cured dental bonding agent (ORTHOSOLO from Ormco) will be applied to the conditioned dental surfaces and then polymerized for 5 seconds. The Attachments Template is loaded with the bonding material (SimpliShade TM Bulk Fill Flow composite from KERR TM) and positioned over the planned teeth to ensure precise placement of the attachments. Then the bonding material will be polymerized for 60 seconds for each attachment, and the template will be carefully removed and then the excess composite will be removed with Tungsten carbide orthodontic bur. Proper positioning and adaptation of the attachments are clinically verified to ensure optimal aligner retention and effective force delivery.
- Appliance Delivery The maxillary and mandibular clear aligners incorporating the reverse twin block design are inserted intraorally. The fit and proper seating of both aligners are carefully checked.
- Occlusal Verification The interaction between the upper and lower bite blocks is evaluated to confirm correct engagement of the inclined planes during mandibular closure. The mandible is guided into the predetermined therapeutic position upon occlusal contact.
- Patient Instructions Patients are instructed to wear the clear aligners for 20-22 hours per day, removing them only during meals and oral hygiene procedures. Detailed instructions regarding insertion, removal, cleaning, and storage of the aligners are provided.
The clinical procedures, including bonding of attachments using a template, appliance delivery, occlusal verification, and patient instructions, were performed according to established protocols for clear aligner therapy.
- Conditions
- Skeletal Class III Malocclusion
- Being tested
- Functional Clear Aligner
- Keywords
- skeletal class III malocclusion, Functional clear aligner, Growing patient, Growth modification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Clear AlignerDevice
A customized functional clear aligner appliance designed as a reverse twin block for growing patients with skeletal Class III malocclusion. The appliance incorporates digitally designed anterior maxillary and posterior mandibular bite blocks with 70° inclined planes to guide controlled mandibular repositioning while maintaining the esthetic and functional advantages of clear aligner therapy.
| Study group | Role | What they receive |
|---|---|---|
| Growing patients with mild skeletal class III | Experimental | Functional Clear Aligner Receives: Device: Functional Clear Aligner |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in skeletal cephalometric measurements
Anteroposterior and vertical skeletal changes will be assessed using standardized lateral cephalometric radiographs obtained at baseline and at the end of treatment. The evaluated parameters include SNA (°), SNB (°), ANB (°), Wits appraisal (mm), lower anterior facial height (LAFH, mm), upper anterior facial height (UAFH, mm), total anterior facial height (TAFH, mm), posterior facial height (PFH, mm), Frankfort mandibular plane angle (FMA, °), and Y-axis angle (°).
Measured: Baseline and at the end of active treatment.
Change in dentoalveolar cephalometric measurements
Dentoalveolar changes will be assessed using standardized lateral cephalometric radiographs obtained at baseline and at the end of treatment. The evaluated parameters include upper incisor inclination to the SN plane (U1-SN, °), lower incisor inclination to the mandibular plane (IMPA, °), interincisal angle (°), U1-NA (mm and °), and L1-NB (mm and °)
Measured: Baseline and at the end of active treatment.
Change in soft tissue cephalometric measurements
soft tissue changes will be assessed using standardized lateral cephalometric radiographs obtained at baseline and at the end of treatment. The evaluated parameters include upper lip to E-line (UL-E, mm), lower lip to E-line (LL-E, mm), and nasolabial angle (°).
Measured: Baseline and at the end of active treatment.
Secondary outcomes (1)
OHRQoL (Oral Health-related Quality of Life) assessments are being incorporated into clinical studies and trials to measure efficaciousness of treatment with the goal of improving care.
Studies involving OHRQoL seek to measure changes in scores from baseline to post-treatment.
The greater the malocclusion (skeletal class III), the lower the QoL. Researchers studying oral health problems have used OHRQoL as an outcome measure to determine the effect of treatment on QoL.
The use of OHRQoL as an evaluative outcome measure is congruent with patientcentered care. Along with other clinical assessments, it allows oral healthcare professionals to evaluate the efficacy of treatment protocols from patients' perspectives.
OHRAoL accurately weigh the risks and benefits associated with treatment. In addition, it provides evidence that costs associated with treatment protocols are worth the expense if they generally improve patients' OHRQoL we should consider sociocultural and psychological factors when assessing needs, outcomes, and clinical practice.
A final consideration in the use of OHRQoL as an outcome measure is addressing and measuring clinically meaningful change.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start12 Feb 2026
- Primary completion13 Feb 2027 (estimated)
- Study completion13 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skeletal Class III MalocclusionStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Functional Clear Aligner
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07703007
- Sponsor's protocol ID
- Eman Elsayed Ali Hashish
- Status last verified
- Feb 2026
- First submitted
- 4 Jul 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make de-identified individual participant data (IPD) available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skeletal and Dentoalveolar Effects of Functional Clear Aligner Therapy in Growing Patient With Skeletal Class III Malocclusion
- ClinicalTrials.gov ID
- NCT07703007
- Acronym / sponsor ID
- Eman Elsayed Ali Hashish
- Conditions
- Skeletal Class III Malocclusion
- Keywords
- skeletal class III malocclusion, Functional clear aligner, Growing patient, Growth modification
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 12 Feb 2026 (actual)
- Primary completion
- 13 Feb 2027 (estimated)
- Study completion
- 13 Jul 2027 (estimated)
- First posted
- 14 Jul 2026 (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.
The purpose of this study is to evaluate the skeletal, dentoalveolar \& soft tissue effects of functional clear aligner therapy in growing patient with Skeletal class III malocclusion. Skeletal class III discrepancy has been a therapeutic challenge due to the fact that its therapeutic management seeks not only the correction of the malocclusion but also the aesthetic component of the patient which is affected according to the severity of the discrepancy. Early diagnosis, planning of adequate therapeutic time and choice of devices to correct malocclusion are the essential keys to successful management of class III in all its forms. Functional appliances are commonly used for the treatment of skeletal class III malocclusion. Removable aesthetic appliance therapy as clear aligner becomes an increasingly common addition to the orthodontic armamentarium. It offers certain advantages over traditional appliance orthodontic treatments; these include fewer clinical emergencies and improved aesthetics, comfort, oral hygiene, periodontal health, and lack of soft tissue irritation. The aim of this study is to evaluate the skeletal, dentoalveolar \& soft tissue effects of functional clear aligner therapy in growing patient with Skeletal class III malocclusion. A total of four blocks are digitally designed, with two blocks placed in the maxillary aligner in the anterior region and two blocks placed in the mandibular aligner in the posterior region. The blocks are designed as inclined planes to guide mandibular repositioning, simulating the reverse twin block mechanism. The upper and lower bite blocks are designed to interact with each other through coherent, specifically designed 70° inclined planes, allowing controlled mandibular repositioning during occlusal contact. Optimized attachments are digitally placed on selected teeth to enhance aligner retention and control tooth movement. Oral Health Related Quality of Life (OHRQoL) assessments will be incorporated as an outcome measure in addressing and measuring clinically meaningful change.
Detailed description
. Fifteen patients with mild skeletal class III were selected according to specific inclusion criteria and included in the study, these patients were treated with Functional Clear Aligner to evaluate its skeletal, dentoalveolar \& soft tissue effects.
Bite registration: The patient intraoral scan will be performed according to the constructor's instructions. The software interface of the intra-oral scanner allows the registration of two different maxillo-mandibular relationships (MMRs).The first MMR scan will be registered in maximum intercuspation occlusion. The second scan will be registered in planned mandibular retrusion for Aesthetic functional appliance design. Bite registration will be done with the mandible in the most retruded position with an inter- incisal clearance of 2 mm and a clearance of 6 mm in the posterior segment.
To obtain an optimal and reproducible MMR scan in mandibular retrusion, curable resin will be used as a bite registration material. Two pieces of resin will be used as bite registration material, placing them (one piece per each side of the dentition) onto the occlusal surface of the posterior dentition. Then mandible will be guided in the most retruded position, this will be performed with a brief preliminary patient training. When the mandible reaches the desired backward position, the occlusal resin will be cured on both sides. Then the two registration pieces of resin will be fully cured outside of the mouth.
Once fully polymerized they will be checked for integrity, and they will be placed in occlusion to check that final mandibular retrusion is adequate and conforms to planned retrusion. Subsequently, patient maxillo-mandibular relationship in mandibular retrusion will be scanned.
During MMR scan acquisition on the right side, only the left piece of resin will be used to maintain mandibular retrusion. Conversely, during MMR scan acquisition on the left side, only the right piece of resin will be used. At the end of the MMR acquisition process, the software will be able to reorient the maxillary and mandibular scan according to the MMR.
Appliance construction: The steps of appliance construction are as follows:
- Import of Digital Scans Digital intraoral scans of the maxillary and mandibular arches are imported into the orthodontic planning software.
- Software Planning and Treatment Setup All software planning steps are performed, including model alignment, occlusal setup, and registration of the construction bite.
- Placement of Attachments Optimized attachments are digitally placed on selected teeth to enhance aligner retention and control tooth movement.
- Design of Mandibular Advancement Blocks A second design phase is performed to incorporate the mandibular advancement blocks. A total of four blocks are digitally designed, with two blocks placed in the maxillary aligner in the anterior region and two blocks placed in the mandibular aligner in the posterior region. The blocks are designed as inclined planes to guide mandibular repositioning, simulating the reverse twin block mechanism. The upper and lower bite blocks are designed to interact with each other through coherent, specifically designed 70° inclined planes, allowing controlled mandibular repositioning during occlusal contact. After the design process, the generated three-dimensional models are exported as files with STL extension and produced using different procedures according to their specific purposes.
- 3D Printing of Aligner Models The finalized digital files are used for three-dimensional printing of the aligner models.
- Thermoforming of Clear Aligners Clear aligners are fabricated by thermoforming thermoplastic sheets over the printed models.
The appliance construction workflow, including digital scanning, virtual treatment planning, attachment design, mandibular advancement block construction, STL file export, three-dimensional printing, and thermoforming of clear aligners, was performed according to previously described digital orthodontic and clear aligner protocols.
Clinical application:
- Bonding of Attachments Composite attachments are bonded on the facial surface of upper and lower central incisors and the upper and lower first permanent molars according to the digitally planned attachment design: Intra-oral bonding procedure will be started with the etching of the facial surface of the maxillary and mandibular central incisors and first permanent molars with (Meta Etchant) for 15-20 seconds. Etched dental surfaces will be washed and dried with chair air-flow and light-cured dental bonding agent (ORTHOSOLO from Ormco) will be applied to the conditioned dental surfaces and then polymerized for 5 seconds. The Attachments Template is loaded with the bonding material (SimpliShade TM Bulk Fill Flow composite from KERR TM) and positioned over the planned teeth to ensure precise placement of the attachments. Then the bonding material will be polymerized for 60 seconds for each attachment, and the template will be carefully removed and then the excess composite will be removed with Tungsten carbide orthodontic bur. Proper positioning and adaptation of the attachments are clinically verified to ensure optimal aligner retention and effective force delivery.
- Appliance Delivery The maxillary and mandibular clear aligners incorporating the reverse twin block design are inserted intraorally. The fit and proper seating of both aligners are carefully checked.
- Occlusal Verification The interaction between the upper and lower bite blocks is evaluated to confirm correct engagement of the inclined planes during mandibular closure. The mandible is guided into the predetermined therapeutic position upon occlusal contact.
- Patient Instructions Patients are instructed to wear the clear aligners for 20-22 hours per day, removing them only during meals and oral hygiene procedures. Detailed instructions regarding insertion, removal, cleaning, and storage of the aligners are provided.
The clinical procedures, including bonding of attachments using a template, appliance delivery, occlusal verification, and patient instructions, were performed according to established protocols for clear aligner therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Functional Clear Aligner
| Arm | Type | Receives |
|---|---|---|
| Growing patients with mild skeletal class III | Experimental | Device: Functional Clear AlignerFunctional Clear Aligner |
Who may qualify
- Ages
- 8 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Patients' age (8-11) years (CVM stages 2-3)
- Mild class III skeletal pattern (Wits appraisal = 0 to -8)
- Mild to moderate reverse overjet (-1 to -4)
- Overbite (1-5)
- Growing patients
Key exclusion criteria (4 listed)
- Severe class III skeletal pattern
- Long facial height
- Bad oral hygiene
- Systemic condition that may interfere with treatment
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 |
|---|---|---|
| Functional Clear AlignerA customized functional clear aligner appliance designed as a reverse twin block for growing patients with skeletal Class III malocclusion. The appliance incorporates digitally designed anterior maxillary and posterior mandibular bite blocks with 70° inclined planes to guide controlled mandibular repositioning while maintaining the esthetic and functional advantages of clear aligner therapy. | Device | Growing patients with mild skeletal class III |
Primary outcome
Change in skeletal cephalometric measurements
Time frame: Baseline and at the end of active treatment.
Anteroposterior and vertical skeletal changes will be assessed using standardized lateral cephalometric radiographs obtained at baseline and at the end of treatment. The evaluated parameters include SNA (°), SNB (°), ANB (°), Wits appraisal (mm), lower anterior facial height (LAFH, mm), upper anterior facial height (UAFH, mm), total anterior facial height (TAFH, mm), posterior facial height (PFH, mm), Frankfort mandibular plane angle (FMA, °), and Y-axis angle (°).
Change in dentoalveolar cephalometric measurements
Time frame: Baseline and at the end of active treatment.
Dentoalveolar changes will be assessed using standardized lateral cephalometric radiographs obtained at baseline and at the end of treatment. The evaluated parameters include upper incisor inclination to the SN plane (U1-SN, °), lower incisor inclination to the mandibular plane (IMPA, °), interincisal angle (°), U1-NA (mm and °), and L1-NB (mm and °)
Change in soft tissue cephalometric measurements
Time frame: Baseline and at the end of active treatment.
soft tissue changes will be assessed using standardized lateral cephalometric radiographs obtained at baseline and at the end of treatment. The evaluated parameters include upper lip to E-line (UL-E, mm), lower lip to E-line (LL-E, mm), and nasolabial angle (°).
1 secondary outcome
OHRQoL (Oral Health-related Quality of Life) assessments are being incorporated into clinical studies and trials to measure efficaciousness of treatment with the goal of improving care.
Time frame: 12 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 14 Jul 2026.
- Individual participant dataSharing planned: No. There is no plan to make de-identified individual participant data (IPD) available to other researchers.
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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.
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 Functional Clear Aligner in people with Skeletal Class III Malocclusion, run by Mansoura University at 1 site in Egypt.
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 4 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 14 Jul 2026. 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 Egypt. 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?
Change in skeletal cephalometric measurements (time frame: Baseline and at the end of active treatment.). 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?
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 14 Jul 2026.