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NCT Number: NCT07191158

Evaluation of Three-Dimensional Printed Orthodontic Molar Distalizer

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.

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Key information

Conditions

Tooth Movement Techniques Distalization by Miniscrews

Age range

16 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

College of Dentistry-University of Baghdad

Baghdad, Al-Russafa, 01110, Iraq

Location status: Recruiting

Location contact

Salwan Pede Professor, PhD

CONTACT

[email protected]

+964 1 4169375

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

-

Exclusion criteria

  • 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. -

Treatment and study plan

Group 1 conventional

Device

Conventional miniscrew-supported distal jet appliance

Group 2 3D printed

Device

New 3D printed miniscrew-supported molar distalizers

Primary outcomes

  1. 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.

Secondary outcomes

  1. Patient discomfort

    Time frame: 10 days

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

  2. 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. - 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

Study contacts

Contact information is provided by the study sponsor or research team.

Mushriq Abid Fawzi Professor, PhD

CONTACT

[email protected]

009647718800706

Sponsors and collaborators

Lead sponsor

University of Baghdad

Other

Registry information

Official study title

Evaluation of Three-Dimensional Printed Orthodontic Molar Distalizer (Randomized Clinical Trial)

Acronym: RCT

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Sep 24, 2025
Registry last updated
Sep 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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