Evaluation of Three-Dimensional Printed Orthodontic Molar Distalizer

NCT07191158 | Recruiting DMC

• 1 other identifier: 1020425
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tooth Movement Techniques; Distalization by Miniscrews

Keywords

Distalization; tooth movement; 3D printing

Outcome Measures

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.

  6 months

Secondary Outcomes (2)

• Patient discomfort

  10 days

• Molar distalization

  6 months

Study Arms (2)

Group 1 distalization

ACTIVE COMPARATOR

Conventional miniscrew-supported distal jet appliance

Device: Group 1 conventional

Group 2 (interventional)

EXPERIMENTAL

New 3D printed miniscrew-supported molar distalizers

Device: Group 2 3D printed

Interventions

Group 1 conventional DEVICE

Conventional miniscrew-supported distal jet appliance

Group 1 distalization

Group 2 3D printed DEVICE

New 3D printed miniscrew-supported molar distalizers

Group 2 (interventional)

Eligibility Criteria

• Age: 16 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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. -

Sponsors & Collaborators

• University of Baghdad: lead

Study Sites (1)

College of Dentistry-University of Baghdad

Baghdad, Al-Russafa, 01110, Iraq

RECRUITING

Related Publications (1)

• 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.

  PMID: 31516664 BACKGROUND

Central Study Contacts

Mushriq Abid Fawzi Professor, PhD

CONTACT

009647718800706; mushriq.abid@codental.uobaghdad.edu.iq

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The study will be a single blinded because both the patients and the investigator will be aware of the allocation during treatment, but the cephalograms and digital models will be scored and coded by an independent person, i.e. pre-and post-treatment cephalograms and digital models will be analyzed after replacing the patients' names with codes, and the examiner conducting the measurement analysis will be unaware of the group to which the patient has been allocated.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 29, 2025
• First Posted: September 24, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: September 24, 2025

Record last verified: 2025-08

Locations

IR (1)