Class III Malocclusion3DRTBNCT07710391
3D Printed Reverse Twin Block for Class III Malocclusion
A study testing 3D printed Reverse Twin Block appliance and Conventional Reverse Twin Block appliance in people with Class III Malocclusion, run by University of Baghdad at 1 site in Iraq.
Trial summary
This RCT aims to evaluate the effectiveness of a novel 3D printed reverse twin block appliance in the management of maxillary deficiency in growing patients having class III malocclusion. Read more about this study
- Who is it for?
- Ages 8 to 13 years
- Conditions the study is for
- Class III Malocclusion
- What is being tested?
- 3D printed Reverse Twin Block appliance and Conventional Reverse Twin Block appliance
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIraq
- Study dates
- 10 Jun 2026to 30 Jun 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 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The age group selected is mixed dentition group 8-13 years with residual potential maxillary growth. Patient maturity will be assessed using the Cervical Vertebral Maturation (CVM) method on lateral cephalogram, patients in CS1-CS3 stages will be included to ensure remaining maxillary growth.
- Presence of permanent first molar with lower anterior teeth to retain the appliance.
- Skeletal/dental class III tendency with anterior cross bite or reverse overjet: a. Clinically the overjet is equal or less than zero up to -3 mm.
- Cephalometric ANB angle equal or less than zero up to -3 degrees and Wits appraisal ≤ -2.
- Prescence of unilateral or bilateral posterior crossbite.
- Mild to moderate anterior crowding.
- Acceptable oral hygiene baseline defined by oral hygiene index (OHI). -
Who cannot join
- Patients with cleft lip and palate and/or craniofacial anomalies.
- History of previous orthopedic and/or orthodontic treatment.
- Presence of uncontrolled systemic disease or medically compromised status.
- Uncooperative patient/parents.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Iraq1 site, 1 recruiting
- Recruiting
Collage of Dentistry, University of Baghdad
Baghdad
About this study
Official title: Effectiveness of a Novel 3D Printed Reverse Twin Block in The Management of Maxillary Deficiency of Class III Malocclusion: A Randomized Clinical Trial
This RCT aims to evaluate the effectiveness of a novel 3D printed reverse twin block appliance in the management of maxillary deficiency in growing patients having class III malocclusion. The clinical outcomes of this appliance will be compared with the conventional reverse twin block appliance over 6 months treatment period.
primary objective is evaluating of the effectiveness of 3DRTB in correcting sagittal discrepancies due to maxillary deficiency in class III malocclusion compared to conventional one while secondary objectives are assessment of transverse and vertical jaw relationship produced by 3DRTB compared to CRTB and to evaluate the soft tissue profile of class III patients and to evaluate the maxillary and mandibular incisor inclination, also assessment of patient perception with both appliances by using questionnaire and finally to assess the impact of 3DRTB on oral health compared to CRTB by using oral hygiene index.
- Conditions
- Class III Malocclusion
- Being tested
- 3D printed Reverse Twin Block appliance, Conventional Reverse Twin Block appliance
- Medical subject headings
- Malocclusion, Angle Class III
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D printed Reverse Twin Block applianceDevice
a CAD-CAM novel reverse twin block appliance will be used for orthopedic management of maxillary deficiency in growing patients with class III malocclusion.
Conventional Reverse Twin Block applianceDevice
a conventionally fabricated Reverse Twin Block appliance will be used for correction of maxillary deficiency in growing patients with class III malocclusion
| Study group | Role | What they receive |
|---|---|---|
| 3D printed Reverse Twin Block appliance | Experimental | patients with class III malocclusion will receive a novel 3D printed reverse twin block with expansion screw for expansion and protraction of maxilla and will be digitally designed using CAD software and fabricated using photopolymer resin. Receives: Device: 3D printed Reverse Twin Block appliance |
| Conventional Reverse Twin Block appliance | Active comparator | patients with class III malocclusion will receive a conventional reverse twin block with expansion screw for expansion and protraction of maxilla and will be fabricated from acrylic resin. Receives: Device: Conventional Reverse Twin Block appliance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in sagittal relation using lateral cephalometric radiograph.
By using cephalometric radiograph skeletal changes in sagittal plane will be measured like: 1. SNA angle in degrees. 2. SNB angle in degrees. 3. ANB angle in degrees. 4. Wits appraisal in degrees. 5. SN-Pog angle
Measured: T0 baseline records T1 3 months after initiation of treatment T2 6 months after initiation of treatment
Secondary outcomes (1)
Transverse relationship by Study model
This will measure by scanned digital study model to calculate the amount of expansion at T0, T1, T2.
- Intermolar width: which is the distance between the mesiobuccal cusp tips of the right and left maxillary first molars.
- Arch length: Arch length will be achieved by measuring the summation of right and left lines that passing through the midpoint between the distal surfaces of the deciduous second molar or the first permanent molar to the midpoint between the central incisors.
Measured: T0 baseline records T1 after 3 months T2 after 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start10 Jun 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Class III MalocclusionStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Linda Basim, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07710391
- Sponsor's protocol ID
- 1213426
- Acronym
- 3DRTB
- Status last verified
- Jun 2026
- First submitted
- 1 Jul 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Novel 3D Printed Reverse Twin Block in The Management of Maxillary Deficiency of Class III Malocclusion: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07710391
- Acronym / sponsor ID
- 3DRTB / 1213426
- Conditions
- Class III Malocclusion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 10 Jun 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 17 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.
This RCT aims to evaluate the effectiveness of a novel 3D printed reverse twin block appliance in the management of maxillary deficiency in growing patients having class III malocclusion. The clinical outcomes of this appliance will be compared with the conventional reverse twin block appliance over 6 months treatment period.
primary objective is evaluating of the effectiveness of 3DRTB in correcting sagittal discrepancies due to maxillary deficiency in class III malocclusion compared to conventional one while secondary objectives are assessment of transverse and vertical jaw relationship produced by 3DRTB compared to CRTB and to evaluate the soft tissue profile of class III patients and to evaluate the maxillary and mandibular incisor inclination, also assessment of patient perception with both appliances by using questionnaire and finally to assess the impact of 3DRTB on oral health compared to CRTB by using oral hygiene index.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3D printed Reverse Twin Block appliance | Experimental | Device: 3D printed Reverse Twin Block appliancepatients with class III malocclusion will receive a novel 3D printed reverse twin block with expansion screw for expansion and protraction of maxilla and will be digitally designed using CAD software and fabricated using photopolymer resin. |
| Conventional Reverse Twin Block appliance | Active comparator | Device: Conventional Reverse Twin Block appliancepatients with class III malocclusion will receive a conventional reverse twin block with expansion screw for expansion and protraction of maxilla and will be fabricated from acrylic resin. |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- The age group selected is mixed dentition group 8-13 years with residual potential maxillary growth. Patient maturity will be assessed using the Cervical Vertebral Maturation (CVM) method on lateral cephalogram, patients in CS1-CS3 stages will be included to ensure remaining maxillary growth.
- Presence of permanent first molar with lower anterior teeth to retain the appliance.
- Skeletal/dental class III tendency with anterior cross bite or reverse overjet: a. Clinically the overjet is equal or less than zero up to -3 mm.
- Prescence of unilateral or bilateral posterior crossbite.
- Mild to moderate anterior crowding.
Key exclusion criteria (4 listed)
- Patients with cleft lip and palate and/or craniofacial anomalies.
- History of previous orthopedic and/or orthodontic treatment.
- Presence of uncontrolled systemic disease or medically compromised status.
- Uncooperative patient/parents.
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 |
|---|---|---|
| 3D printed Reverse Twin Block appliancea CAD-CAM novel reverse twin block appliance will be used for orthopedic management of maxillary deficiency in growing patients with class III malocclusion. | Device | 3D printed Reverse Twin Block appliance |
| Conventional Reverse Twin Block appliancea conventionally fabricated Reverse Twin Block appliance will be used for correction of maxillary deficiency in growing patients with class III malocclusion | Device | Conventional Reverse Twin Block appliance |
Primary outcome
Changes in sagittal relation using lateral cephalometric radiograph.
Time frame: T0 baseline records T1 3 months after initiation of treatment T2 6 months after initiation of treatment
By using cephalometric radiograph skeletal changes in sagittal plane will be measured like: 1. SNA angle in degrees. 2. SNB angle in degrees. 3. ANB angle in degrees. 4. Wits appraisal in degrees. 5. SN-Pog angle
1 secondary outcome
Transverse relationship by Study model
Time frame: T0 baseline records T1 after 3 months T2 after 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 21 Jul 2026.
- Individual participant dataSharing planned: No
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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 3D printed Reverse Twin Block appliance and Conventional Reverse Twin Block appliance in people with Class III Malocclusion, 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 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: looking for participants now, as of the sponsor's last update on 21 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 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?
Contact Linda Basim, PhD (+9647812867005, landa.hadi2403@codental.uobaghdad.edu.iq), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in sagittal relation using lateral cephalometric radiograph. (time frame: T0 baseline records T1 3 months after initiation of treatment T2 6 months after initiation of treatment). 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 21 Jul 2026.