CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 30 enrolled
Drug / intervention
Lower molar distalization +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06859606
NCT06859606N/ACompleted

Mandibular Sequential Distalization Versus Class III Elastics With Clear Aligners in Class III Patients: a Randomized Controlled Trial

Saint Camillus International University of Health Sciences·interventional·Posted Mar 5, 2025·Updated Mar 5, 2025

In Brief

A clinical study evaluating Lower molar distalization and Class III elastics for Class III Malocclusion. Completed, enrolled 30 participants across 1 site.

Detailed Summary

Distalizing mandibular molars may be indicated for patients with minor skeletal Class III discrepancies or in Class III subjects with mild crowding. Traditionally, mandibular molar distalization was accomplished using elastics, open coils, and the multiloop edgewise archwire technique. In recent years, several techniques have been developed to reduce the dependence on patient compliance, such as skeletal anchorage. Recently, several reports have been published on mandibular distal movement using miniscrews and some case reports have shown the possibility of obtaining Class III correction with sequential mandibular distalization in non-growing subjects by means of clear aligners. However, a sound clinical judgment should always be made on the basis of a higher level of evidence. Therefore, the purpose of the present prospective study is to provide a detailed analysis of the underlying skeletal and dental changes determined by mandibular distalization therapy with the sequential Invisalign protocol in permanent dentition. This will be accomplished by testing the following null hypothesis: mandibular molar distalization is not achievable with aligners without the application of TADs.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly
Collaborators--

Timeline

N/ACompletedFinished
2023202420252026
First PostedMar 5, 2025
Enrollment StartDec 1, 2022
Primary CompletionDec 1, 2024
Study CompletionJan 10, 2025
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 1.3 years ago

Interventions

Lower molar distalizationother

Lower Distalization Protocol included extraction of the lower third molars before starting treatment and a 50% sequential lower distalization with two teeth being distalized at a time. The distalization started with the movement of lower second molars, followed by the first molars halfway through the process, and so on. Once the canine reached the right position, the "en masse" retraction of the four incisors completed the treatment plan. The protocol comprised the use of Class III intermaxillary elastics to support the distalization movement and to control the proclination of lower incisors

Class III elasticsother

Non-Distalization Protocol featured extraction of the lower third molars before starting treatment, transversal dento-alveolar coordination, strategic interproximal reduction (IPR) in the anterior segment of the lower arch, and the addition of Class III elastics