Vertical Effects in Class II Patients Treated With Distalization

NCT05298280 | Completed DMC

• 1 other identifier: 257/21
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Class II malocclusion presents a major and common challenge to orthodontists. Treatment of Class II malocclusion is one of the most investigated and controversial issues in contemporary orthodontics because of the extensive variability of treatment strategies addressing the morphological characteristics of this malocclusion. The therapeutic approaches include tooth extractions, orthopedic appliances and extraoral or intraoral distalizing appliances. Maxillary molar distalization is one of the most common strategies to correct Class II molar relationship and it is commonly indicated for patients with maxillary dentoalveolar protrusion or minor skeletal discrepancies. One of the most used devices is Pendulum appliance, introducted by Hilgers in 1992. In the last decades, the orthodontic treatment with removable clear aligners has become an increasing common choice because of the growing number of adult patients who ask for aesthetic and comfortable alternatives to conventional fixed appliances. In 1997, Align Technology (Santa Clara, Calif) adapted and incorporated modern technologies to introduce the clear aligner treatment (CAT). Only few investigations have focused on the predictability of orthodontic tooth movement with CAT. A systematic review by Rossini et al. pointed out that among the dental movements analyzed in 11 studies, the bodily distalization was the most predictable. Clinicians can consider the use of aligners in treatment planning for adult patients requiring 2 to 3 mm of maxillary molar distalization. However, a detailed analysis of the skeletal and dental changes that compared pendulum appliance and clear aligners in class II treatment is still lacking. On the basis of these considerations, the aim of the present prospective study was to analyze the effects on vertical dentoskeletal changes following maxillary molar distalization with pendulum and full fixed appliances and clear aligners.

Conditions

Malocclusion, Angle Class II

Keywords

Class II; Pendulum; Distalization; Clear Aligners

Outcome Measures

Primary Outcomes (1)

• SN^GoGn

  The SN-GoGn angle is an angular measurement included in the study to quantify the inclination of the mandibular base relative to the cranial base. Its average value is 32°

  At the beginning and at the end of the teraphy

Secondary Outcomes (1)

• Overjet

  At the beginning and at the end of the teraphy

Study Arms (2)

Pendulum Group (PG)

ACTIVE COMPARATOR

In the PG, all patients received a pendulum appliance as described by Angelieri et al. The Nance button was anchored to the first and second premolars with removable wires.

Device: Pendulum appliance

Clear Aligner Group (CAG)

ACTIVE COMPARATOR

The treatment of sequential upper arch distalization was performed by the same board-certified orthodontists as proposed by Align Technology and described by Ravera et al.

Device: clear aligners

Interventions

Pendulum appliance DEVICE

In the PG, all patients received a pendulum appliance as described by Angelieri et al. The Nance button was anchored to the first and second premolars with removable wires. The 0.032-inch TMA wires were activated 45 degrees to produce a force of 200-250g per side. On average, intraoral reactivation of the distalizing springs was performed twice during the procedure. When a super Class I molar relationship was obtained, pendulum was replaced by a Nance holding arch. The average treatment duration was 8 months followed by bracket conventional therapy.

Pendulum Group (PG)

clear aligners DEVICE

The standardized orthodontic intervention was represented by the maxillary molar distalization protocol proposed by Align Technology: it was planned in order to obtain a sequential distalization on the upper arch, and the staging was set at 0.25 mm per aligner. During sequential distalization aligners are set up to distalize one tooth at a time. The attachments were engineered by Align Technology to achieve predictable tooth movements. Each couple of aligners was worn for 7 days.

Clear Aligner Group (CAG)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• bilateral Class II or end to end Class II molar relationship
• skeletal Class I or II malocclusion (ANB angle between 2° and 7°)
• normodivergence on the vertical plane (SN\^GoGn angle less than 37°)
• crowding in the lower arch (≤6 mm)
• good quality of pre and post treatment radiographs
• good general health with healthy periodontium

You may not qualify if:

• patients who required functional appliance therapy
• those who had previous orthodontic treatment or extraction
• hypodontia
• craniofacial syndromes or cleft
• previous prosthodontic treatments of the upper molars

Sponsors & Collaborators

• University of Rome Tor Vergata: lead

Study Sites (1)

University of Rome "Tor Vergata"

Roma, 00133, Italy

Location

Related Publications (11)

• Byloff FK, Darendeliler MA. Distal molar movement using the pendulum appliance. Part 1: Clinical and radiological evaluation. Angle Orthod. 1997;67(4):249-60. doi: 10.1043/0003-3219(1997)0672.3.CO;2.

  PMID: 9267573 BACKGROUND

• Ghosh J, Nanda RS. Class II, Division 1 malocclusion treated with molar distalization therapy. Am J Orthod Dentofacial Orthop. 1996 Dec;110(6):672-7. doi: 10.1016/s0889-5406(96)80046-1.

  PMID: 8972815 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

• Angelieri F, de Almeida RR, Janson G, Castanha Henriques JF, Pinzan A. Comparison of the effects produced by headgear and pendulum appliances followed by fixed orthodontic treatment. Eur J Orthod. 2008 Dec;30(6):572-9. doi: 10.1093/ejo/cjn060.

  PMID: 19054813 BACKGROUND

• de Almeida-Pedrin RR, Henriques JF, de Almeida RR, de Almeida MR, McNamara JA Jr. Effects of the pendulum appliance, cervical headgear, and 2 premolar extractions followed by fixed appliances in patients with Class II malocclusion. Am J Orthod Dentofacial Orthop. 2009 Dec;136(6):833-42. doi: 10.1016/j.ajodo.2007.12.032.

  PMID: 19962606 BACKGROUND

• Hilgers JJ. The pendulum appliance for Class II non-compliance therapy. J Clin Orthod. 1992 Nov;26(11):706-14. No abstract available.

  PMID: 1298751 BACKGROUND

• Bussick TJ, McNamara JA Jr. Dentoalveolar and skeletal changes associated with the pendulum appliance. Am J Orthod Dentofacial Orthop. 2000 Mar;117(3):333-43. doi: 10.1016/s0889-5406(00)70238-1.

  PMID: 10715093 BACKGROUND

• Kravitz ND, Kusnoto B, BeGole E, Obrez A, Agran B. How well does Invisalign work? A prospective clinical study evaluating the efficacy of tooth movement with Invisalign. Am J Orthod Dentofacial Orthop. 2009 Jan;135(1):27-35. doi: 10.1016/j.ajodo.2007.05.018.

  PMID: 19121497 BACKGROUND

• Rossini G, Parrini S, Castroflorio T, Deregibus A, Debernardi CL. Efficacy of clear aligners in controlling orthodontic tooth movement: a systematic review. Angle Orthod. 2015 Sep;85(5):881-9. doi: 10.2319/061614-436.1. Epub 2014 Nov 20.

  PMID: 25412265 BACKGROUND

• Caruso S, Nota A, Ehsani S, Maddalone E, Ojima K, Tecco S. Impact of molar teeth distalization with clear aligners on occlusal vertical dimension: a retrospective study. BMC Oral Health. 2019 Aug 13;19(1):182. doi: 10.1186/s12903-019-0880-8.

  PMID: 31409348 BACKGROUND

• Lione R, Balboni A, Di Fazio V, Pavoni C, Cozza P. Effects of pendulum appliance versus clear aligners in the vertical dimension during Class II malocclusion treatment: a randomized prospective clinical trial. BMC Oral Health. 2022 Oct 10;22(1):441. doi: 10.1186/s12903-022-02483-w.

  PMID: 36217134 DERIVED

MeSH Terms

Conditions

Malocclusion, Angle Class II

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The observer (BA) who performed all the measurements was blinded to the group assignment. The study was blinded in regard to the statistical analysis: blinding was obtained by eliminating from the elaboration file every reference to patient group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Researcher

Model Details: Subjects enrolled in the study were randomly assigned to the two groups: Pendulum Group (PG) Clear Aligner Group (CAG). All subjects were treated by the same clinician. A computer-generated random number list was used to allocate patients to treatments. Block randomization was used to assign the same number of patients to each treatment. The allocation sequence was concealed by the statistician, who used opaque and sealed envelopes, sequentially numbered for each patient.

Study Record Dates

• First Submitted: March 17, 2022
• First Posted: March 28, 2022
• Study Start: January 1, 2019
• Primary Completion: July 31, 2021
• Study Completion: December 31, 2021
• Last Updated: March 28, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share

Locations

IT (1)