Tooth Movement TechniquesRCTNCT07191158
Evaluation of Three-Dimensional Printed Orthodontic Molar Distalizer
A study testing Group 1 conventional and Group 2 3D printed in people with Tooth Movement Techniques and Distalization by Miniscrews, run by University of Baghdad at 1 site in Iraq.
Trial summary
A randomized clinical trial to evaluate a newly designed 3D printed miniscrew-supported molar distalization device in comparison to the conventional miniscrew-supported distal jet appliance in correction of Class II malocclusion and upper arch crowding. Read more about this study
- Who is it for?
- Ages 16 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Movement Techniques, Distalization by Miniscrews
- What is being tested?
- Group 1 conventional and Group 2 3D printed
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteIraq
- Study dates
- 1 Feb 2025to 1 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 16 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Class II molar relationships bilaterally, with fully erupted 2nd molar.
- No or minor crowding on the mandible to [reserve Class I posterior occlusion after treatment.
- Good oral health free from caries and periodontal problems at the start of treatment.
- -
Who cannot join
- Previous history of orthopedic and/or orthodontic treatment.
- Patients with cleft lip and palate and/or craniofacial syndrome
- Patients with bad oral habit.
- Active periodontal disease.
- Sever rotation of maxillary molars. -
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
College of Dentistry-University of Baghdad
Baghdad, Al-Russafa, 01110
Salwan Pede Professor, PhD, +964 1 4169375, ethical.approval@codental.uobaghdad.edu.iq
About this study
Official title: Evaluation of Three-Dimensional Printed Orthodontic Molar Distalizer (Randomized Clinical Trial)
A randomized clinical trial to evaluate a newly designed 3D printed miniscrew-supported molar distalization device in comparison to the conventional miniscrew-supported distal jet appliance in correction of Class II malocclusion and upper arch crowding.
Read the detailed description
It is a multicenter randomized clinical trial with two parallel arms. The patients will be randomly divided into two groups, group one: conventional miniscrew-supported distal jet appliance will be used while for group two, new 3D printed miniscrew-supported molar distalizers is going to be utilized. Lateral cephalometric x-ray and digital models of upper arch will be taken before starting the treatment (T0) and at the end of molar distalization (T1). The effectiveness of the two appliances will be assessed and measured comparing patient's records before and after treatment.
- Being tested
- Group 1 conventional, Group 2 3D printed
- Keywords
- Distalization, tooth movement, 3D printing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1 conventionalDevice
Conventional miniscrew-supported distal jet appliance
Group 2 3D printedDevice
New 3D printed miniscrew-supported molar distalizers
| Study group | Role | What they receive |
|---|---|---|
| Group 1 distalization | Active comparator | Conventional miniscrew-supported distal jet appliance Receives: Device: Group 1 conventional |
| Group 2 (interventional) | Experimental | New 3D printed miniscrew-supported molar distalizers Receives: Device: Group 2 3D printed |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of molar Distalization
- The efficiency of molar distalization in terms of the amount of molar distalization, degree of distal tipping and bodily translation movements by using a lateral cephalogram linear and angular measurements.
Measured: 6 months
Secondary outcomes (2)
Patient discomfort
- Patient's pain and discomfort using visual analogue scale (VAS). The minimum score is zero and the maximum score is 10.
Measured: 10 days
Molar distalization
The efficiency of molar distalization in terms of the amount of molar distalization, degree of distal tipping and bodily translation movements by using a lateral cephalogram linear and angular measurements. - The efficiency of molar distalization in terms of the amount of molar distalization, - degree of distal tipping and bodily translation movements by using a lateral cephalogram linear and angular measurements
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2025
- Study start1 Feb 2025
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tooth Movement TechniquesStudies of the same condition, open and under way.
- More trials run by University of BaghdadThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mushriq F. Abid, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07191158
- Sponsor's protocol ID
- 1020425
- Acronym
- RCT
- Status last verified
- Aug 2025
- First submitted
- 29 Aug 2025
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cassetta M, Brandetti G, Altieri F. Miniscrew-supported distal jet versus conventional distal jet appliance: A pilot study. J Clin Exp Dent. 2019 Jul 1;11(7):e650-e658. doi: 10.4317/jced.55780. eCollection 2019 Jul.
PubMed 31516664
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Three-Dimensional Printed Orthodontic Molar Distalizer (Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT07191158
- Acronym / sponsor ID
- RCT / 1020425
- Keywords
- Distalization, tooth movement, 3D printing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 24 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized clinical trial to evaluate a newly designed 3D printed miniscrew-supported molar distalization device in comparison to the conventional miniscrew-supported distal jet appliance in correction of Class II malocclusion and upper arch crowding.
Detailed description
It is a multicenter randomized clinical trial with two parallel arms. The patients will be randomly divided into two groups, group one: conventional miniscrew-supported distal jet appliance will be used while for group two, new 3D printed miniscrew-supported molar distalizers is going to be utilized. Lateral cephalometric x-ray and digital models of upper arch will be taken before starting the treatment (T0) and at the end of molar distalization (T1). The effectiveness of the two appliances will be assessed and measured comparing patient's records before and after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 distalization | Active comparator | Device: Group 1 conventionalConventional miniscrew-supported distal jet appliance |
| Group 2 (interventional) | Experimental | Device: Group 2 3D printedNew 3D printed miniscrew-supported molar distalizers |
Who may qualify
- Ages
- 16 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Class II molar relationships bilaterally, with fully erupted 2nd molar.
- No or minor crowding on the mandible to [reserve Class I posterior occlusion after treatment.
- Good oral health free from caries and periodontal problems at the start of treatment.
- -
Key exclusion criteria (5 listed)
- Previous history of orthopedic and/or orthodontic treatment.
- Patients with cleft lip and palate and/or craniofacial syndrome
- Patients with bad oral habit.
- Active periodontal disease.
- Sever rotation of maxillary 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 |
|---|---|---|
| Group 1 conventionalConventional miniscrew-supported distal jet appliance | Device | Group 1 distalization |
| Group 2 3D printedNew 3D printed miniscrew-supported molar distalizers | Device | Group 2 (interventional) |
Primary outcome
The rate of molar Distalization
Time frame: 6 months
• The efficiency of molar distalization in terms of the amount of molar distalization, degree of distal tipping and bodily translation movements by using a lateral cephalogram linear and angular measurements.
2 secondary outcomes
Patient discomfort
Time frame: 10 days
Molar distalization
Time frame: 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 24 Sep 2025.
- Background: PubMed 31516664Cassetta M, Brandetti G, Altieri F. Miniscrew-supported distal jet versus conventional distal jet appliance: A pilot study. J Clin Exp Dent. 2019 Jul 1;11(7):e650-e658. doi: 10.4317/jced.55780. eCollection 2019 Jul.
- 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 Group 1 conventional and Group 2 3D printed in people with Tooth Movement Techniques and Distalization by Miniscrews, 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 4 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: looking for participants now, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mushriq Abid Fawzi Professor, PhD (009647718800706, mushriq.abid@codental.uobaghdad.edu.iq), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of molar Distalization (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07191158, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025.