Skeletal Class III MalocclusionPhase 1NCT07376954
Management of Skeletal Class III Malocclusion With Digital Bonded Reverse Twin Block in Mixed Dentition
A Phase 1 study testing Digital Bonded Reverse Twin Block 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 dentoalveolar \& skeletal effects of digital bonded reverse twin block in treatment of skeletal class III malocclusion in mixed dentition. Class III malocclusion presents significant management and prognostic challenges due to the complex interplay of factors in its etiology. 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?
- Digital Bonded Reverse Twin Block
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteEgypt
- Study dates
- 19 May 2025to 20 Oct 2026
- Phase
- Phase 1
- 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)
- Mixed dentition
- Mild to moderate reverse overjet (-1 to -4)
- Overbite (1-5)
- 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
- No premolars or deciduous molars
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
The purpose of this study is to evaluate dentoalveolar \& skeletal effects of digital bonded reverse twin block in treatment of skeletal class III malocclusion in mixed dentition.
Class III malocclusion presents significant management and prognostic challenges due to the complex interplay of factors in its etiology. 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. The aim of this study is to evaluate dentoalveolar \& skeletal effects of digital bonded reverse twin block (DBRTB) in treatment of skeletal class III malocclusion in mixed dentition. The digital workflow allows full appliance customization creating a perfect adaptation of the four blocks with patient dental anatomy thus optimizing bonding procedures and block retention. The DBRTB will be designed as four occlusal blocks, two blocks for the upper arch, and two blocks for the lower arch. The upper blocks will be bonded to the anterior part of the maxillary arch, the lower blocks will be bonded to the posterior part of the mandibular arch. Upper and lower blocks will interact with each other through coherent specifically designed 70° inclined planes. Transfer transparent trays will be used to support the bonding procedure of the blocks. 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
The study includes two groups: (Study design: non-randomized clinical trial)
- Group 1: control group untreated retrospective data of skeletal class III patients
- Group 2: patients treated with digital bonded reverse twin block (DBRTB) -Twenty one patients with mild skeletal class III were selected according to specific inclusion criteria and included in the study, these patients were treated with Digital Bonded Reverse Twin Block (DBRTB) to evaluate its dentoalveolar and skeletal effect
Bite registration:
The patient intraoral scan will be obtained using Medit i-700 intraoral scanner. The 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 DBRTB 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 first step of the appliance design is to transform the intra-oral scans into two working models for appliance construction: upper working model and the lower working model.
The DBRTB will be designed as four occlusal bites. Two bites for the upper arch, and two bites for the lower arch. The upper bites will be bonded in the anterior region of the maxillary arch, the lower bites will be bonded in the posterior part of the mandibular arch. Upper and lower bites will interact with each other through coherent specifically designed 70° inclined planes.
After the design process, the following 3D models will be exported as files with STL extension and produced with different procedures and specific purposes:
- upper blocks (right and left) to be bonded on the anterior region of the maxillary arch.
- lower blocks (right and left) to be bonded on the posterior region of the mandibular arch.
Both upper and lower blocks will be produced using Poly-Methyl-Meth-Acrylate (PMMA).
Transparent Polyethylene 0.8mm trays will be used to assist the clinician during the blocks bonding procedures.
Clinical application:
The blocks will be placed inside the transfer transparent trays to ensure a precise bonding position and to reduce the risk of saliva contamination during the bonding procedure.
Intra-oral bonding procedure will be started with the etching of the occlusal surface of the maxillary and mandibular dentition with (Meta Etchant) for 15-20 seconds. Etched dental surfaces will be washed and dried with chair air-flow and light-cured dental adhesive (ORTHOSOLO from Ormco) will be applied to the conditioned dental surfaces. Air-flow will be used again to uniformly spread the adhesive on the teeth surfaces and finally the adhesive will be polymerized for 5 seconds.
BracePaste® Band and Build LC (from American Orthodontics) will be used to bond the blocks. It is decided to use this material to have possibility to distinguish it during blocks debonding.
The bonding material will be placed on the four blocks preliminary positioned into the thermoplastic trays. Subsequently, blocks will be positioned on the dentition with the support of thermoplastic trays and immediately polymerized through the clear trays for 60 seconds per block.
Additionally, the bonding material will be polymerized for 60 seconds for each block after trays removal. At the end of the polymerization process, the blue bonding material excess will be removed with white stone finishing bur.
- Conditions
- Skeletal Class III Malocclusion
- Being tested
- Digital Bonded Reverse Twin Block
- Keywords
- Skeletal class III malocclusion, Digital bonded reverse twin block, Mixed dentition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Bonded Reverse Twin BlockDevice
Appliance construction:
- upper blocks (right and left) to be bonded on the anterior region of the maxillary arch.
- lower blocks (right and left) to be bonded on the posterior region of the mandibular arch.
Both upper and lower blocks will be produced using Poly-Methyl-Meth-Acrylate (PMMA).
Upper and lower blocks will interact with each other through coherent specifically designed 70° inclined planes.
Transparent Polyethylene 0.8mm trays will be used to assist the clinician during the blocks bonding procedures.
| Study group | Role | What they receive |
|---|---|---|
| Growing patients with mild skeletal class III | Active comparator | Digital Bonded Reverse Twin Block Receives: Device: Digital Bonded Reverse Twin Block |
| Retrospective skeletal class III patients | No intervention | Untreated |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dentoalveolar and skeletal effect of Digital bonded Reverse Twin Block in mixed dentition
Digital Bonded Reverse Twin Block is composed of four fixed blocks , 2 blocks cemented on upper premolars or deciduous molars \& 2 blocks cemented on lower permanent molars with inclined planes 70 degrees One of the most engaging aspects of the DBRTB is its immediate facial treatment effects. Patient and their parents, immediately had the perception of facial profile modification. These facial changes can significantly improve the psychological patient's condition, improving their self-esteem and potentially making patients more confident.
The digital workflow allows full appliance customization creating a perfect adaptation of the four blocks with patient dental anatomy thus optimizing bonding procedures and block retention.
The dental effect of DBRTB is proclination of upper incisors, retroclination of lower incisors The skeletal effect of DBRTB is evaluated from cephalometric measurements: increase in SNA, decrease in SNB and ANB after ttt of mild skeletal class III cases
Measured: 12 months
Dentoalveolar and skeletal effect of Digital bonded Reverse Twin Block in mixed dentition
Digital Bonded Reverse Twin Block is composed of four fixed blocks , 2 blocks cemented on upper premolars or deciduous molars \& 2 blocks cemented on lower permanent molars with inclined planes 70 degrees.
One of the most engaging aspects of the DBRTB is its immediate facial treatment effects. Patient and their parents, immediately had the perception of facial profile modification. These facial changes can significantly improve the psychological patient's condition, improving their self-esteem and potentially making patients more confident.
The digital workflow allows full appliance customization creating a perfect adaptation of the four blocks with patient dental anatomy thus optimizing bonding procedures and block retention.
The dental effect of DBRTB is proclination of upper incisors, retroclination of lower incisors The skeletal effect of DBRTB is evaluated from cephalometric measurements: increase in SNA, decrease in SNB and ANB after ttt of mild skeletal class III cases
Measured: 12 months
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 patient-centered care. Along with other clinical assessments, it allows oral healthcare professionals to evaluate the efficacy of treatment protocols from patients' perspectives.
OHRAoL accurately weighs 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 posted29 Jan 2026
- Study start19 May 2025
- Primary completion20 May 2026 (estimated)
- Study completion20 Oct 2026 (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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Digital Bonded Reverse Twin Block
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 21 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
- NCT07376954
- Sponsor's protocol ID
- Eman Abdelkhabir
- Status last verified
- May 2025
- First submitted
- 23 Dec 2025
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Skeletal Class III Malocclusion With Digital Bonded Reverse Twin Block in Mixed Dentition
- ClinicalTrials.gov ID
- NCT07376954
- Acronym / sponsor ID
- Eman Abdelkhabir
- Conditions
- Skeletal Class III Malocclusion
- Keywords
- Skeletal class III malocclusion, Digital bonded reverse twin block, Mixed dentition
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 19 May 2025 (actual)
- Primary completion
- 20 May 2026 (estimated)
- Study completion
- 20 Oct 2026 (estimated)
- First posted
- 29 Jan 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 dentoalveolar \& skeletal effects of digital bonded reverse twin block in treatment of skeletal class III malocclusion in mixed dentition.
Class III malocclusion presents significant management and prognostic challenges due to the complex interplay of factors in its etiology. 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. The aim of this study is to evaluate dentoalveolar \& skeletal effects of digital bonded reverse twin block (DBRTB) in treatment of skeletal class III malocclusion in mixed dentition. The digital workflow allows full appliance customization creating a perfect adaptation of the four blocks with patient dental anatomy thus optimizing bonding procedures and block retention. The DBRTB will be designed as four occlusal blocks, two blocks for the upper arch, and two blocks for the lower arch. The upper blocks will be bonded to the anterior part of the maxillary arch, the lower blocks will be bonded to the posterior part of the mandibular arch. Upper and lower blocks will interact with each other through coherent specifically designed 70° inclined planes. Transfer transparent trays will be used to support the bonding procedure of the blocks. Oral Health Related Quality of Life (OHRQoL) assessments will be incorporated as an outcome measure in addressing and measuring clinically meaningful change.
Detailed description
The study includes two groups: (Study design: non-randomized clinical trial)
- Group 1: control group untreated retrospective data of skeletal class III patients
- Group 2: patients treated with digital bonded reverse twin block (DBRTB) -Twenty one patients with mild skeletal class III were selected according to specific inclusion criteria and included in the study, these patients were treated with Digital Bonded Reverse Twin Block (DBRTB) to evaluate its dentoalveolar and skeletal effect
Bite registration:
The patient intraoral scan will be obtained using Medit i-700 intraoral scanner. The 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 DBRTB 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 first step of the appliance design is to transform the intra-oral scans into two working models for appliance construction: upper working model and the lower working model.
The DBRTB will be designed as four occlusal bites. Two bites for the upper arch, and two bites for the lower arch. The upper bites will be bonded in the anterior region of the maxillary arch, the lower bites will be bonded in the posterior part of the mandibular arch. Upper and lower bites will interact with each other through coherent specifically designed 70° inclined planes.
After the design process, the following 3D models will be exported as files with STL extension and produced with different procedures and specific purposes:
- upper blocks (right and left) to be bonded on the anterior region of the maxillary arch.
- lower blocks (right and left) to be bonded on the posterior region of the mandibular arch.
Both upper and lower blocks will be produced using Poly-Methyl-Meth-Acrylate (PMMA).
Transparent Polyethylene 0.8mm trays will be used to assist the clinician during the blocks bonding procedures.
Clinical application:
The blocks will be placed inside the transfer transparent trays to ensure a precise bonding position and to reduce the risk of saliva contamination during the bonding procedure.
Intra-oral bonding procedure will be started with the etching of the occlusal surface of the maxillary and mandibular dentition with (Meta Etchant) for 15-20 seconds. Etched dental surfaces will be washed and dried with chair air-flow and light-cured dental adhesive (ORTHOSOLO from Ormco) will be applied to the conditioned dental surfaces. Air-flow will be used again to uniformly spread the adhesive on the teeth surfaces and finally the adhesive will be polymerized for 5 seconds.
BracePaste® Band and Build LC (from American Orthodontics) will be used to bond the blocks. It is decided to use this material to have possibility to distinguish it during blocks debonding.
The bonding material will be placed on the four blocks preliminary positioned into the thermoplastic trays. Subsequently, blocks will be positioned on the dentition with the support of thermoplastic trays and immediately polymerized through the clear trays for 60 seconds per block.
Additionally, the bonding material will be polymerized for 60 seconds for each block after trays removal. At the end of the polymerization process, the blue bonding material excess will be removed with white stone finishing bur.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Digital Bonded Reverse Twin Block
| Arm | Type | Receives |
|---|---|---|
| Growing patients with mild skeletal class III | Active comparator | Device: Digital Bonded Reverse Twin BlockDigital Bonded Reverse Twin Block |
| Retrospective skeletal class III patients | No intervention | –Untreated |
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)
- Mixed dentition
- Mild to moderate reverse overjet (-1 to -4)
- Overbite (1-5)
Key exclusion criteria (5 listed)
- Severe class III skeletal pattern
- Long facial height
- Bad oral hygiene
- Systemic condition that may interfere with treatment
- No premolars or deciduous molars
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 |
|---|---|---|
| Digital Bonded Reverse Twin BlockAppliance construction: * upper blocks (right and left) to be bonded on the anterior region of the maxillary arch. * lower blocks (right and left) to be bonded on the posterior region of the mandibular arch. Both upper and lower blocks will be produced using Poly-Methyl-Meth-Acrylate (PMMA). Upper and lower blocks will interact with each other through coherent specifically designed 70° inclined planes. Transparent Polyethylene 0.8mm trays will be used to assist the clinician during the blocks bonding procedures. | Device | Growing patients with mild skeletal class III |
Primary outcome
Dentoalveolar and skeletal effect of Digital bonded Reverse Twin Block in mixed dentition
Time frame: 12 months
Digital Bonded Reverse Twin Block is composed of four fixed blocks , 2 blocks cemented on upper premolars or deciduous molars \& 2 blocks cemented on lower permanent molars with inclined planes 70 degrees One of the most engaging aspects of the DBRTB is its immediate facial treatment effects. Patient and their parents, immediately had the perception of facial profile modification. These facial changes can significantly improve the psychological patient's condition, improving their self-esteem and potentially making patients more confident. The digital workflow allows full appliance customization creating a perfect adaptation of the four blocks with patient dental anatomy thus optimizing bonding procedures and block retention. The dental effect of DBRTB is proclination of upper incisors, retroclination of lower incisors The skeletal effect of DBRTB is evaluated from cephalometric measurements: increase in SNA, decrease in SNB and ANB after ttt of mild skeletal class III cases
Dentoalveolar and skeletal effect of Digital bonded Reverse Twin Block in mixed dentition
Time frame: 12 months
Digital Bonded Reverse Twin Block is composed of four fixed blocks , 2 blocks cemented on upper premolars or deciduous molars \& 2 blocks cemented on lower permanent molars with inclined planes 70 degrees. One of the most engaging aspects of the DBRTB is its immediate facial treatment effects. Patient and their parents, immediately had the perception of facial profile modification. These facial changes can significantly improve the psychological patient's condition, improving their self-esteem and potentially making patients more confident. The digital workflow allows full appliance customization creating a perfect adaptation of the four blocks with patient dental anatomy thus optimizing bonding procedures and block retention. The dental effect of DBRTB is proclination of upper incisors, retroclination of lower incisors The skeletal effect of DBRTB is evaluated from cephalometric measurements: increase in SNA, decrease in SNB and ANB after ttt of mild skeletal class III cases
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 29 Jan 2026.
Related trials for Skeletal Class III Malocclusion
Not yet recruiting
Clinical and Radiographic Evaluation of Low Sagittal Medial Ramus Osteotomy for Treatment of Skeletal Class II and Class III Malocclusion
Skeletal Class II Malocclusion, Skeletal Class III Malocclusion
Enrolling by invitation
Skeletal and Dentoalveolar Effects of Functional Clear Aligner Therapy in Growing Patient With Skeletal Class III Malocclusion
Skeletal Class III Malocclusion
Not yet recruiting
Effects of Invisalign Palatal Expander vs Rapid Palatal Expander With Facemask in Growing Class III Patients
Skeletal Class III Malocclusion, Transverse Maxillary Deficiency
Not yet recruiting
Comparison of Maxillary Protraction Using Tooth-borne Facemask Versus Skeletal Anchorage Chin-plate in Class III Growing Patients
Skeletal Class III Malocclusion
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 Phase 1 study testing Digital Bonded Reverse Twin Block 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 5 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 29 Jan 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Dentoalveolar and skeletal effect of Digital bonded Reverse Twin Block in mixed dentition (time frame: 12 months). The study lists 2 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 29 Jan 2026.