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RecruitingNCT07191158RCTUpdated Sep 24, 2025

Evaluation of Three-Dimensional Printed Orthodontic Molar Distalizer

An interventional study of Group 1 conventional and Group 2 3D printed in Tooth Movement Techniques and Distalization by Miniscrews, sponsored by University of Baghdad. Recruiting at 1 site in Iraq. Open to participants aged 16 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-24.

Sponsored by University of Baghdad · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Feb 2025, registered Aug 2025).
  • Started Feb 2025; still recruiting 1 year 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
16 Years to 30 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Tooth Movement Techniques
  • Distalization by Miniscrews

Keywords

  • Distalization
  • tooth movement
  • 3D printing
03

In context

Lead sponsor

University of Baghdad is the lead sponsor of 164 studies on the registry; 66 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Class II molar relationships bilaterally, with fully erupted 2nd molar.
  2. No or minor crowding on the mandible to [reserve Class I posterior occlusion after treatment.
  3. Good oral health free from caries and periodontal problems at the start of treatment.

    -

Exclusion criteria

Exclusion Criteria:

  1. Previous history of orthopedic and/or orthodontic treatment.
  2. Patients with cleft lip and palate and/or craniofacial syndrome
  3. Patients with bad oral habit.
  4. Active periodontal disease.
  5. Sever rotation of maxillary molars. -
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
28 participants (estimated)

Study arms

  • Active comparator
    Group 1 distalization

    Conventional miniscrew-supported distal jet appliance

    Device: Group 1 conventional

  • Experimental
    Group 2 (interventional)

    New 3D printed miniscrew-supported molar distalizers

    Device: Group 2 3D printed

Interventions

  • DeviceGroup 1 conventional

    Conventional miniscrew-supported distal jet appliance

  • DeviceGroup 2 3D printed

    New 3D printed miniscrew-supported molar distalizers

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 months

Secondary outcomes

  1. Patient discomfort

    • Patient's pain and discomfort using visual analogue scale (VAS). The minimum score is zero and the maximum score is 10.

    Time frame: 10 days

  2. 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

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

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 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07191158
Lead sponsor
University of Baghdad
Responsible party
Mushriq F. Abid (Professor, University of Baghdad) — Principal investigator
First posted
Sep 24, 2025
Start date
Feb 1, 2025
Primary completion
Sep 1, 2026 (estimated)
Completion
Apr 1, 2027 (estimated)
Last update
Sep 24, 2025

Study contacts

Mushriq Abid Fawzi Professor, PhD
Contact
mushriq.abid@codental.uobaghdad.edu.iq
009647718800706

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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