Class II MalocclusionNCT07340242
Dentoskeletal Effects of 3D-Printed Fixed Twin Block Versus MARA Appliances in Management of Skeletal Class II
A study testing MARA appliance and fixed twin block in people with Class II Malocclusion and Mandibular Deficiency, run by Mansoura University at 1 site in Egypt.
Trial summary
Objective: to evaluate the dentoskeletal effects of CAD/CAM 3D-Printed fixed twin block versus MARA appliances in the management of skeletal class II due to Mandibular Deficiency in Preadolescence Class II malocclusion is considered one of the most commonly observed problems among orthodontic patients, representing… Read more about this study
- Who is it for?
- Ages 9 to 14 years
- Conditions the study is for
- Class II Malocclusion, Mandibular Deficiency
- What is being tested?
- MARA appliance and fixed twin block
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 27 Apr 2025to 27 Apr 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 9 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Skeletal Class II malocclusion due to mandibular retrusion.
- Overjet ≥ 6.0 mm.
- Normal or low-angle growth pattern.
- Minimum crowding in the mandibular arch.
- Undergoing circumpubertal phase of skeletal development (CVMI 2, 3, and 4)
Who cannot join
- Clinical signs and symptoms of temporomandibular disorder.
- Systemic disease affecting bone and general growth.
- Previous orthodontic treatment
- Cleft lip or palate.
- Congenital craniofacial deformity.
- Abnormal oral habits.
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, 1 recruiting
- Recruiting
Faculty of dentistry, Mansoura university
Al Mansurah, Dakahlia Governorate, 35516
050 2267151
About this study
Official title: Dentoskeletal Effects of CAD/CAM 3D-Printed Fixed Twin Block Versus MARA Appliances in the Management of Skeletal Class II Due to Mandibular Deficiency in Preadolescence: A Randomized Controlled Trial
Objective: to evaluate the dentoskeletal effects of CAD/CAM 3D-Printed fixed twin block versus MARA appliances in the management of skeletal class II due to Mandibular Deficiency in Preadolescence Class II malocclusion is considered one of the most commonly observed problems among orthodontic patients, representing around one-third of the patients seeking orthodontic treatment reflecting a significant economic impact. Various removable and fixed functional appliances are commonly used to stimulate mandibular growth. Fixed Twin-block appliance has advantages compared with removable Twin-block and Herbst appliances. The mandibular anterior repositioning appliance is referred to as M.A.R.A. appliance.
Materials and method: The study design is a randomized controlled trial in which the control group and intervention groups will be assessed as parallel groups with a 1:1:1 allocation ratio. Sixty subjects will be enrolled in this research. They will be divided equally into three groups: untreated control, MARA group and Twin block group
- Conditions
- Class II Malocclusion, Mandibular Deficiency
- Being tested
- MARA appliance, fixed twin block
- Medical subject headings
- Overbite, Micrognathism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MARA applianceDevice
CAD/CAM 3D printed mandibular anterior repositioning appliance
fixed twin blockDevice
CAD/CAM 3D printed fixed twin block
| Study group | Role | What they receive |
|---|---|---|
| Control group, who will be the untreated group. | No intervention | Not described |
| . MARA group, who will undergo MARA appliance | Active comparator | Not described Receives: Device: MARA appliance |
| Fixed twin block group, who will undergo fixed twin block appliance | Active comparator | Not described Receives: Device: fixed twin block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Linear Skeletal changes of the maxilla and mandible using cephalometric measurements
linear (mm) measurement
Measured: From date of randomization until the date of first documented acceptable correction assessed up to 6 months
Angular skeletal changes of the maxilla and mandible using cephalometric measurements
angular (°) measurement
Measured: From date of randomization until the date of first documented acceptable correction assessed up to 6 months
Linear dental changes of the maxilla and mandible using cephalometric measurements
linear (mm) measurement
Measured: From date of randomization until the date of first documented acceptable correction assessed up to 6 months
Angular dental changes of the maxilla and mandible using cephalometric measurements
angular (°) measurement
Measured: From date of randomization until the date of first documented acceptable correction assessed up to 6 months
Linear soft tissue changes of the maxilla and mandible using cephalometric measurements
linear (mm) measurement
Measured: From date of randomization until the date of first documented acceptable correction assessed up to 6 months
Angular soft tissue changes of the maxilla and mandible using cephalometric measurements
angular (°) measurement
Measured: From date of randomization until the date of first documented acceptable correction assessed up to 6 months
Secondary outcomes (5)
Oral health quality of life questionnaire
The questionnaire (COHIP-SF-AR) will be given to the participants once informed consent is obtained at 5-time points: before treatment, 1 week, 1 month, 3 months, and 6 months after wearing functional appliances.
Measured: From date of randomization until the date of first documented acceptable correction assessed up to 6 months
Incidence of breakages and harms reported during routine or emergency visits in both groups
Details of complications in both groups, including breakages and harms reported during routine or emergency visits, will be registered and categorized according to their nature and severity using a previously published classification system
Measured: From date of randomization until the date of first documented acceptable correction assessed up to 6 months
Arch perimeter and depth measurement from digital model analysis
linear (mm) measurement
Measured: From date of randomization until the date of first documented acceptable correction assessed up to 6 months
Maxillary inter-canine width from digital model analysis
linear (mm) measurement
Measured: From date of randomization until the date of first documented acceptable correction assessed up to 6 months
Maxillary inter-first molar width from digital model analysis
linear (mm)measurement
Measured: From date of randomization until the date of first documented acceptable correction assessed 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 posted14 Jan 2026
- Study start27 Apr 2025
- Primary completion15 Oct 2026 (estimated)
- Study completion27 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Class II 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasmin Ghaly, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07340242
- Sponsor's protocol ID
- MDP.25.03.5
- Status last verified
- Jan 2026
- First submitted
- 21 Nov 2025
- Last updated
- 14 Jan 2026
- 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 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dentoskeletal Effects of CAD/CAM 3D-Printed Fixed Twin Block Versus MARA Appliances in the Management of Skeletal Class II Due to Mandibular Deficiency in Preadolescence: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07340242
- Acronym / sponsor ID
- MDP.25.03.5
- Conditions
- Class II Malocclusion, Mandibular Deficiency
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 27 Apr 2025 (actual)
- Primary completion
- 15 Oct 2026 (estimated)
- Study completion
- 27 Apr 2027 (estimated)
- First posted
- 14 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.
Objective: to evaluate the dentoskeletal effects of CAD/CAM 3D-Printed fixed twin block versus MARA appliances in the management of skeletal class II due to Mandibular Deficiency in Preadolescence Class II malocclusion is considered one of the most commonly observed problems among orthodontic patients, representing around one-third of the patients seeking orthodontic treatment reflecting a significant economic impact. Various removable and fixed functional appliances are commonly used to stimulate mandibular growth. Fixed Twin-block appliance has advantages compared with removable Twin-block and Herbst appliances. The mandibular anterior repositioning appliance is referred to as M.A.R.A. appliance.
Materials and method: The study design is a randomized controlled trial in which the control group and intervention groups will be assessed as parallel groups with a 1:1:1 allocation ratio. Sixty subjects will be enrolled in this research. They will be divided equally into three groups: untreated control, MARA group and Twin block group
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group, who will be the untreated group. | No intervention | – |
| . MARA group, who will undergo MARA appliance | Active comparator | Device: MARA appliance |
| Fixed twin block group, who will undergo fixed twin block appliance | Active comparator | Device: fixed twin block |
Who may qualify
- Ages
- 9 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Skeletal Class II malocclusion due to mandibular retrusion.
- Overjet ≥ 6.0 mm.
- Normal or low-angle growth pattern.
- Minimum crowding in the mandibular arch.
- Undergoing circumpubertal phase of skeletal development (CVMI 2, 3, and 4)
Key exclusion criteria (6 listed)
- Clinical signs and symptoms of temporomandibular disorder.
- Systemic disease affecting bone and general growth.
- Previous orthodontic treatment
- Cleft lip or palate.
- Congenital craniofacial deformity.
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 |
|---|---|---|
| MARA applianceCAD/CAM 3D printed mandibular anterior repositioning appliance | Device | . MARA group, who will undergo MARA appliance |
| fixed twin blockCAD/CAM 3D printed fixed twin block | Device | Fixed twin block group, who will undergo fixed twin block appliance |
Primary outcome
Linear Skeletal changes of the maxilla and mandible using cephalometric measurements
Time frame: From date of randomization until the date of first documented acceptable correction assessed up to 6 months
linear (mm) measurement
Angular skeletal changes of the maxilla and mandible using cephalometric measurements
Time frame: From date of randomization until the date of first documented acceptable correction assessed up to 6 months
angular (°) measurement
Linear dental changes of the maxilla and mandible using cephalometric measurements
Time frame: From date of randomization until the date of first documented acceptable correction assessed up to 6 months
linear (mm) measurement
Angular dental changes of the maxilla and mandible using cephalometric measurements
Time frame: From date of randomization until the date of first documented acceptable correction assessed up to 6 months
angular (°) measurement
Linear soft tissue changes of the maxilla and mandible using cephalometric measurements
Time frame: From date of randomization until the date of first documented acceptable correction assessed up to 6 months
linear (mm) measurement
Angular soft tissue changes of the maxilla and mandible using cephalometric measurements
Time frame: From date of randomization until the date of first documented acceptable correction assessed up to 6 months
angular (°) measurement
5 secondary outcomes
Oral health quality of life questionnaire
Time frame: From date of randomization until the date of first documented acceptable correction assessed up to 6 months
Incidence of breakages and harms reported during routine or emergency visits in both groups
Time frame: From date of randomization until the date of first documented acceptable correction assessed up to 6 months
Arch perimeter and depth measurement from digital model analysis
Time frame: From date of randomization until the date of first documented acceptable correction assessed up to 6 months
Maxillary inter-canine width from digital model analysis
Time frame: From date of randomization until the date of first documented acceptable correction assessed up to 6 months
Maxillary inter-first molar width from digital model analysis
Time frame: From date of randomization until the date of first documented acceptable correction assessed up to 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 14 Jan 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MARA appliance and fixed twin block in people with Class II Malocclusion and Mandibular Deficiency, 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 5 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: looking for participants now, as of the sponsor's last update on 14 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.
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?
Contact Yasmin s Ghaly, phd (+201065152020, yasminghaly@mans.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Linear Skeletal changes of the maxilla and mandible using cephalometric measurements (time frame: From date of randomization until the date of first documented acceptable correction assessed up to 6 months). The study lists 6 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 Jan 2026.