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Completed

NCT Number: NCT06859606

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

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Saint Camillus International University of Health Sciences

Rome, 00131, Italy

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Lower molar distalization

Other

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 elastics

Other

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

Primary outcomes

  1. 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)

    Time frame: from the start of treatment to the end at 24 months

    L6-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 outcomes

  1. Changes in inclination of the lower incisors (IMPA angle)

    Time frame: from the start of treatment to the and at 24 months

    IMPA angle: angle between long axis of the lower incisor and mandibular plane

  2. Changes in position of the lower incisors (L1-CoGo mm; L1apex - CoGo)

    Time frame: from the start of treatment to the and at 24 months

    L1-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

  3. Sagittal skeletal changes (SNA angle, SNB angle, ANB angle)

    Time frame: from start of treatment to to the end at 24 months

    SNA angle: maxillary sagittal position SNB angle: mandibular sagittal position ANB angle: maxillomandibular sagittal discrepancy

  4. Sagittal skeletal changes (Wits appraisal)

    Time frame: from start of treatment to to the end at 24 months

    Wits appraisal: maxillomandibular sagittal discrepancy

  5. Vertical skeletal changes (SN^MP angle, Gonial Angle)

    Time frame: from the start of treatment to the end at 24 months

    SN-MP angle between Sella/Nasion plane and Mandibular plane Gonial angle, angle between Ar-Go plane and Go-Me plane

  6. Changes of upper incisors inclination

    Time frame: from the start of treatment to the and at 24 months

    Incisor inclintion: angle between long axis of upper incisor and Sella Nasion

  7. Overbite and Overjet values

    Time frame: from the start of treatment to the and at 24 months

    Overbite 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

Sponsors and collaborators

Lead sponsor

Saint Camillus International University of Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Mar 5, 2025
Registry last updated
Mar 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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