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Comparison of Maxillary Molar Distalization: Miniscrew Implant vs Clear Aligners

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Study Aim

This study compares the use of miniscrew implants and clear aligners for distalizing maxillary molars in orthodontic treatment. We will measure and assess the anteroposterior and angular changes in the molar position at different stages of the treatment using cephalometric analysis and cast analysis from intraoral scans.

What is being tested

Upper molar distalization

Procedure
Who is being recruted

Malocclusion+2

+ Malocclusion, Angle Class II

+ Stomatognathic Diseases

Until 30 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: April 2024
See protocol details

Summary

Principal SponsorAristotle University Of Thessaloniki
Study ContactAikaterini Samandara, Doctor of Dental SurgeryMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 10, 2024

Actual date on which the first participant was enrolled.

This clinical trial aims to compare two different methods for moving upper back teeth (known as molars) backwards, which is called distalization. The study involves patients who need orthodontic treatment to correct their bite by moving the molars into a better position. One group will use a special device supported by small implants called miniscrews, and the other group will use clear aligners with elastic bands. This research is important as it could help determine which method is more effective for certain orthodontic treatments, potentially offering better solutions for patients who need to adjust their molar positions. The study involves patients being randomly placed into one of the two groups. In the first group, the treatment involves using a device supported by miniscrews placed in the mouth to help move the molars. The second group will wear clear aligners that also help in moving the molars with the aid of elastic bands. Throughout the study, detailed scans and x-rays of the patients' teeth and jaw will be taken at different stages to measure the progress. These measurements will help researchers see how much the teeth have moved and how effective each method is. The study aims to ensure that the final result achieves a good alignment of the teeth and a proper bite.

Official TitleComparison of Distalization of Maxillary First and Second Molars Between a Miniscrew Implant Supported Device and Clear Aligners: A Randomized Clinical Trial.
NCT07040176
Principal SponsorAristotle University Of Thessaloniki
Study ContactAikaterini Samandara, Doctor of Dental SurgeryMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Until 30 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

MalocclusionMalocclusion, Angle Class IIStomatognathic DiseasesTooth DiseasesOverbite

Criteria

3 inclusion criteria required to participate
Patients with at least half cusp bilateral Class II malocclusion between upper and lower first molars due to maxillary excess or maxillary protrusion or forward movement of the maxillary posterior teeth, where maxillary molar distalization is indicated.
Patients in the permanent dentition period of less than 30 years of age with second molars erupted at least one half.
Patients with good general health and healthy periodontium.
7 exclusion criteria prevent from participating
Patients with Class II malocclusion between upper and lower first molars due to mandibular deficiency or mandibular retrusion.
Patients with less than half cusp bilateral Class II malocclusion between upper and lower first molars.
Patients with unilateral Class II malocclusion between upper and lower first molars.
Patients with cleft lip and palate or with other craniofacial syndromes.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
The AMDA arm consists of patients that will be treated initially for molar distalization with a miniscrew implant supported device (AMDA®) and for anterior teeth retraction (after molar distalization) with the same device and fixed appliances. The miniscrew implants will be inserted in the anterior region of the palate, especially 6-9 mm posterior to the incisive foramen and 3-6 mm paramedian.

Group II

Active Comparator
The Spark® arm consists of patients that will be treated with clear aligners and elastics for both molar distalization and anterior teeth retraction.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Department of Orthodontics, Faculty of Dentistry, School of Medical Sciences, Aristotle University of Thessaloniki

Thessaloniki, GreeceOpen Department of Orthodontics, Faculty of Dentistry, School of Medical Sciences, Aristotle University of Thessaloniki in Google Maps
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One Study Center