Comparison of Distalization of Maxillary First and Second Molars Between a Miniscrew Implant Supported Device and Clear Aligners.

NCT07040176 | Recruiting

• 1 other identifier: protoc.numb. 21/14-12-2023
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this randomized clinical trial is to compare distalization of maxillary first and second molars achieved with a device supported with mini screw implants in the palate (Advanced Molar Distalization Appliance, AMDA®) with distalization of maxillary first and second molars achieved with clear aligners (Spark®) supported by Class II elastics. The main questions it aims to answer are: Is there any difference in achieving upper molar distalization with the Advanced Molar Distalization Appliance (AMDA®) supported by miniscrew implants and with clear aligners (Spark®) supported by Class II elastics at the end of active distalization phase? Is there any difference between the two groups in the anchorage loss at the end of total treatment? Additionally, the differences in the movements of premolars, canines and incisors will be analyzed in all three planes of space (sagittal, transverse, vertical), as well as the duration of treatment between the two groups and subgroup comparisons will be performed regarding age, gender, presence of maxillary third molars and severity of malocclusion. Participants will be randomly assigned to the AMDA® or Spark® group. Treatment will take place at the Department of Orthodontics and participants will have to visit the clinic every 4-6 weeks for regular check ups. Intraoral scans, photographs and x-rays (panoramic x-ray, cephalometric x-rays) will be taken before treatment, at the end of active distalization phase and at the end of treatment.

Conditions

Distalization; Class II Malocclusion; Aligner Therapy; Distalization by Miniscrews

Keywords

Class II malocclusion; Distalization; Orthodontics; Aligners; Miniscrew implants

Outcome Measures

Primary Outcomes (4)

• Linear measurements for anteroposterior changes of maxillary first molar distalization movement at the end of active distalization (until Class I molar relationship is achieved).

  Cephalometric analysis performed in lateral x-rays and cast analysis performed in intraoral scans will provide us with linear measurements assessing the anteroposterior movement of maxillary first molars.

  T1: Baseline records (initial records before the beginning of treatment). T2: 8-12 months, end of distalization phase records (records taken at the end of upper molar distalization, when upper first molars will be bilaterally in Class I malocclusion).

• Linear measurements for anteroposterior changes of maxillary first molar distalization movement at the end of total orthodontic treatment.

  Cephalometric analysis performed in lateral x-rays and cast analysis performed in intraoral scans will provide us with linear measurements assessing the anteroposterior movement of maxillary first molars at the end of orthodontic treatment.

  T1: Baseline records, (initial records before the beginning of treatment). T3: End of treatment records (records taken at the end of orthodontic treatment after removal of all orthodontic appliances), an average of 24 months.

• Angular measurements for anteroposterior changes of maxillary first molar distalization movement at the end of active distalization (until Class I molar relationship is achieved).

  Cephalometric analysis performed in lateral x-rays will provide us with angular measurements assessing the anteroposterior movement of maxillary first molars.

  T1: Baseline records (initial records before the beginning of treatment). T2: 8-12 months, end of distalization phase records (records taken at the end of upper molar distalization, when upper first molars will be bilaterally in Class I malocclusion).

• Angular measurements for anteroposterior changes of maxillary first molar distalization movement at the end of total orthodontic treatment.

  Cephalometric analysis performed in lateral x-rays will provide us with angular measurements assessing the anteroposterior movement of maxillary first molars at the end of orthodontic treatment.

  T1: Baseline records, (initial records before the beginning of treatment). T3: End of treatment records (records taken at the end of orthodontic treatment after removal of all orthodontic appliances), an average of 24 months.

Secondary Outcomes (2)

• Duration of active distalization phase

  T1: Baseline records (initial records before the beginning of treatment). T2: 8-12 months, at the end of distalization phase (records taken at the end of upper molar distalization, when upper first molars will be bilaterally in Class I malocclusion).

• Duration of total treatment

  T1: Baseline records, (initial records before the beginning of treatment). T3: End of treatment records (records taken at the end of orthodontic treatment after removal of all orthodontic appliances), an average of 24 months.

Study Arms (2)

AMDA® (Advanced Molar Distalization Appliance)

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.

Procedure: Upper molar distalization

Spark®

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.

Procedure: Upper molar distalization

Interventions

Upper molar distalization PROCEDURE

This study aims to compare upper molar distalization movement achieved with a non-compliance miniscrew implant supported appliance (AMDA®) with distalization of upper molars achieved with clear aligners (Spark®) supported by Class II elastics.

AMDA® (Advanced Molar Distalization Appliance); Spark®

Eligibility Criteria

• Age: Up to 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Patients with missing, or congenital missing or supernumerary teeth.
• Patients with full coverage molar restorations.
• Patients with previous orthodontic treatment.

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (1)

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

Thessaloniki, 54124, Greece

RECRUITING

Related Publications (4)

• Wilmes B, Drescher D. Application and effectiveness of the Beneslider: a device to move molars distally. World J Orthod. 2010 Winter;11(4):331-40.

  PMID: 21490998 BACKGROUND

• Ravera S, Castroflorio T, Garino F, Daher S, Cugliari G, Deregibus A. Maxillary molar distalization with aligners in adult patients: a multicenter retrospective study. Prog Orthod. 2016;17:12. doi: 10.1186/s40510-016-0126-0. Epub 2016 Apr 18.

  PMID: 27041551 BACKGROUND

• Papadopoulos MA, Melkos AB, Athanasiou AE. Noncompliance maxillary molar distalization with the first class appliance: a randomized controlled trial. Am J Orthod Dentofacial Orthop. 2010 May;137(5):586.e1-586.e13; discussion 586-7. doi: 10.1016/j.ajodo.2009.10.033.

  PMID: 20451774 BACKGROUND

• Antonarakis GS, Kiliaridis S. Maxillary molar distalization with noncompliance intramaxillary appliances in Class II malocclusion. A systematic review. Angle Orthod. 2008 Nov;78(6):1133-40. doi: 10.2319/101507-406.1.

  PMID: 18947282 BACKGROUND

MeSH Terms

Conditions

Overbite

Condition Hierarchy (Ancestors)

Malocclusion, Angle Class II; Malocclusion; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Moschos Papadopoulos, Professor

  Aristotle University Of Thessaloniki

  STUDY CHAIR

Central Study Contacts

Aikaterini Samandara, Doctor of Dental Surgery

CONTACT

+306945299800; katerinasamandara@gmail.com

Moschos Papadopoulos, Professor

CONTACT

+302310999556; mikepap@dent.auth.gr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 19, 2025
• First Posted: June 27, 2025
• Study Start: April 10, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: IPD and supporting information will be available 1 month after publication with no end date.
• Access Criteria: IPD and supporting information will be shared upon request after contacting the primary investigator of the study.

Locations

GR (1)