Evaluation of Three-Dimensional Printed Orthodontic Molar Distalizer

Not Applicable

Recruiting

• Conditions: Tooth Movement Techniques; Distalization by Miniscrews

• Registration Number: NCT07191158
• Lead Sponsor: University of Baghdad

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.

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 Timeline

• Study Start: 2025-02-01
• Status Verified: 2025-08
• Study First Submitted: 2025-08-29
• Study First Submitted QC: 2025-09-22
• Last Update Submitted: 2025-09-22
• Study First Posted: 2025-09-24
• Last Update Posted: 2025-09-24
• Primary Completion: 2026-09-01
• Study Completion: 2027-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 28

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

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. -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The rate of molar Distalization	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 Outcome Measures

Name	Time	Method
Patient discomfort	10 days	• Patient's pain and discomfort using visual analogue scale (VAS). The minimum score is zero and the maximum score is 10.
Molar distalization	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

Trial Locations

Locations (1)

College of Dentistry-University of Baghdad; 🇮🇶 Baghdad, Al-Russafa, Iraq