Skip to content

Mandibular Sequential Distalization Versus Class III Elastics With Clear Aligners in Class III Patients

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06859606
Enrollment
30
Registered
2025-03-05
Start date
2022-12-01
Completion date
2025-01-10
Last updated
2025-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Class III Malocclusion

Keywords

class III malocclusion, lower molar distalization, class III elastics, clear aligner treatment

Brief 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.

Detailed description

Class III malocclusion is considered one of the most challenging maxillofacial disorders in clinical practice characterized by an antero-posterior discrepancy with mandibular protrusion, maxillary retrusion, or a combination of both. In adult patients, managing this condition is further complicated by the absence of residual skeletal growth, limiting therapeutic options to orthodontic interventions and, in some cases, surgical procedures. Diagnosis in Class III adult patients requires distinguishing between skeletal malocclusion and dento-alveolar discrepancy. The combination of orthognathic surgery and orthodontic therapy represents the gold standard for more severe skeletal Class III disharmonies, leading to an improvement of both function and aesthetics. On the other hand, in Class III cases characterized by a prevalent dental component or mild skeletal discrepancy, the malocclusion can be addressed with a dento-alveolar compensation. In these cases, the clinical objectives are to achieve a correct sagittal, canine and molar Class I relationship, as well as ideal values of overjet and overbite. The non-surgical orthopedic approach involves the application of Class III elastics or the distalization of the lower molars, which can improve the sagittal occlusal relationship. As a matter of fact, mandibular distalization allows the increase of lower arch length along with the achievement of the necessary space to correct a Class III relationship. However, bone density and root anatomy make lower molar distalization difficult to achieve. In addition, one of the most frequent adverse effects is represented by the anterior anchorage loss with a worsening of lower incisor proclination and overjet values. Traditional appliances feature the use of open coil springs, inter arch elastics, and lip bumper device combined with fixed appliances. Nowadays, the development of clear aligner technology provides new opportunities even in the management of complex malocclusion cases, including Class III discrepancies. In particular, molar distalization movements and intermaxillary elastics have been proposed as a valid clinical strategy to improve the occlusal relationship without requiring skeletal anchorage devices. During the sagittal mechanics, over-corrected movements should be planned in order to obtain more bodily movements of the lower molars. Moreover, the best accuracy and predictability of distalization movements are supported by the sequential staging and the presence of attachments on the tooth surfaces. Nowadays, scientific evidence on this topic is limited and it is influenced by restrictions in terms of sample size, retrospective design, and lack of long-term observation. Hence, the aim of the present study was to evaluate the efficacy and efficiency of intermaxillary elastics combined with lower molar distalization by means of clear aligners in the treatment of Class III malocclusion in adult patients. More specifically, a randomized controlled trial (RCT) was conducted to evaluate the antero-posterior correction induced by Class III elastics combined with lower distalization movements and the application of Class III elastics alone. The possibility of achieving satisfying clinical outcomes without the use of skeletal anchorage was considered to avoid an invasive orthodontic approach

Interventions

OTHERLower molar distalization

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

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

Sponsors

Saint Camillus International University of Health Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* adult age (≥19 years) * permanent dentition including second permanent molars * skeletal Class I or slight Class III (-2° \< ANB \< +2°) * normal skeletal divergency pattern (SN\^GoGn, 27°-37°) * Class III canine and molar relationship at baseline (T0), moderate lower arch crowding (≤ +4 mm) * good compliance with aligners and elastics (≥ 20 hours/day)

Exclusion criteria

* severe skeletal Class III malocclusion (ANB \< -2°) * transversal maxillary deficiency * use of Temporary Anchorage Devices (TADs) * extraction treatments other than third molars * periodontal disease or temporomandibular disorders (TMDs).

Design outcomes

Primary

MeasureTime frameDescription
Lower molar positional changes expressed by means of linear and angular measurements (L6-MP mm; L6-MP angle; L6 - CoGo mm; L6 apex - CoGo mm)from the start of treatment to the end at 24 monthsL6-MP mm: linear distance between the mesial cusp of lower first molar and Mandibular plane L6-MP angle: angle between long axis of lower first molar and Mandibular plane L6 - CoGo mm: linear distance between the mesial cusp of lower first molar and CoGo line L6 apex - CoGo mm: linear distance between the apex of lower first molar and CoGo line

Secondary

MeasureTime frameDescription
Changes in position of the lower incisors (L1-CoGo mm; L1apex - CoGo)from the start of treatment to the and at 24 monthsL1-CoGo mm: linear distance between the tip crown of the lower incisor L1apex - CoGo mm: linear distance between the apex of the lower incisor and CoGo line
Sagittal skeletal changes (SNA angle, SNB angle, ANB angle)from start of treatment to to the end at 24 monthsSNA angle: maxillary sagittal position SNB angle: mandibular sagittal position ANB angle: maxillomandibular sagittal discrepancy
Sagittal skeletal changes (Wits appraisal)from start of treatment to to the end at 24 monthsWits appraisal: maxillomandibular sagittal discrepancy
Changes in inclination of the lower incisors (IMPA angle)from the start of treatment to the and at 24 monthsIMPA angle: angle between long axis of the lower incisor and mandibular plane
Changes of upper incisors inclinationfrom the start of treatment to the and at 24 monthsIncisor inclintion: angle between long axis of upper incisor and Sella Nasion
Overbite and Overjet valuesfrom the start of treatment to the and at 24 monthsOverbite mm: horizontal distance between the upper and lower incisors on the occlusal plane Overjet mm: vertical distance between the upper and lower incisors on the occlusal plane
Vertical skeletal changes (SN^MP angle, Gonial Angle)from the start of treatment to the end at 24 monthsSN-MP angle between Sella/Nasion plane and Mandibular plane Gonial angle, angle between Ar-Go plane and Go-Me plane

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026