Therapeutic Effects of Class II Elastics on Aligners in Different Vertical Skeletal Patterns

NCT05853211 | Not Yet Recruiting

• 1 other identifier: 2023PI022
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The objective is to compare the dento-alveolar therapeutic effects of wearing class II inter-arch traction elastics on aligners versus multi-brackets in an adult population. The principal hypothesis is no significant difference in therapeutic effects of using inter-arch elastics on aligners versus multi-brackets.

Conditions

Malocclusion, Angle Class II

Keywords

aligner; inter-arch elastic; orthodontic; class II malocclusion; adult; clear aligner; orthodontic appliance; Invisalign; class II elastics; angle class II malocclusion

Outcome Measures

Primary Outcomes (1)

• Change in IMPA Mandibular incisor angle (degrees)

  Angle between the mandibular plane and the lower incisor axis: position of the lower incisor in relation to the mandible

  First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months.

Secondary Outcomes (24)

• Sex

  1 month

• Duration of treatment

  24 months

• Change in interproximal dental size

  First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months

• Change in skeletal sagittal pattern ANB angle

  First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months

• Change in skeletal sagittal pattern Ao-Bo

  First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months

Study Arms (2)

Clear aligner

Patient with class II malocclusion, treated with class II elastics on aligners

Combination Product: Aligner and inter-arch elastics

Fixed appliance

Patient with class II malocclusion, treated with class II elastics on fixed appliance

Interventions

Aligner and inter-arch elastics COMBINATION_PRODUCT

Correction of class II malocclusion by class II elastics on clear aligners

Clear aligner

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult with class II malocclusion treated with class II elastics

You may qualify if:

• CVM stage 5 on lateral teleradiography (end of growth)
• Angle Class II
• Treatments with rubber bands for inter-arch traction
• End of treatment in class I

You may not qualify if:

• Incomplete data
• Treatment with extractions, mini-screws, mini-plate or ortho-surgical treatment
• Dental agenesis (excluding wisdom teeth)
• Cranial-facial syndromes

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

DEON

Nancy, Lorraine, 54000, France

Location

Related Publications (14)

• Janson G, Sathler R, Fernandes TM, Branco NC, Freitas MR. Correction of Class II malocclusion with Class II elastics: a systematic review. Am J Orthod Dentofacial Orthop. 2013 Mar;143(3):383-92. doi: 10.1016/j.ajodo.2012.10.015.

  PMID: 23452973 BACKGROUND

• Robertson L, Kaur H, Fagundes NCF, Romanyk D, Major P, Flores Mir C. Effectiveness of clear aligner therapy for orthodontic treatment: A systematic review. Orthod Craniofac Res. 2020 May;23(2):133-142. doi: 10.1111/ocr.12353. Epub 2019 Nov 13.

  PMID: 31651082 BACKGROUND

• Zheng M, Liu R, Ni Z, Yu Z. Efficiency, effectiveness and treatment stability of clear aligners: A systematic review and meta-analysis. Orthod Craniofac Res. 2017 Aug;20(3):127-133. doi: 10.1111/ocr.12177. Epub 2017 May 26.

  PMID: 28547915 BACKGROUND

• Lombardo L, Colonna A, Carlucci A, Oliverio T, Siciliani G. Class II subdivision correction with clear aligners using intermaxilary elastics. Prog Orthod. 2018 Sep 1;19(1):32. doi: 10.1186/s40510-018-0221-5.

  PMID: 30171391 BACKGROUND

• Dianiskova S, Rongo R, Buono R, Franchi L, Michelotti A, D'Anto V. Treatment of mild Class II malocclusion in growing patients with clear aligners versus fixed multibracket therapy: A retrospective study. Orthod Craniofac Res. 2022 Feb;25(1):96-102. doi: 10.1111/ocr.12500. Epub 2021 May 31.

  PMID: 34013659 BACKGROUND

• Duncan LO, Piedade L, Lekic M, Cunha RS, Wiltshire WA. Changes in mandibular incisor position and arch form resulting from Invisalign correction of the crowded dentition treated nonextraction. Angle Orthod. 2016 Jul;86(4):577-83. doi: 10.2319/042415-280.1. Epub 2015 Dec 4.

  PMID: 26636248 BACKGROUND

• Amm E, El Amm C, Vaden J. Effect of Class II elastics on different mandibular arch preparation stabilized with aligners and stainless-steel wires: A FEM study. Orthod Craniofac Res. 2022 Nov;25(4):520-529. doi: 10.1111/ocr.12564. Epub 2022 Jan 27.

  PMID: 35015923 BACKGROUND

• Rongo R, Dianiskova S, Spiezia A, Bucci R, Michelotti A, D'Anto V. Class II Malocclusion in Adult Patients: What Are the Effects of the Intermaxillary Elastics with Clear Aligners? A Retrospective Single Center One-Group Longitudinal Study. J Clin Med. 2022 Dec 9;11(24):7333. doi: 10.3390/jcm11247333.

  PMID: 36555949 BACKGROUND

• Deregibus A, Tallone L, Rossini G, Parrini S, Piancino M, Castroflorio T. Morphometric analysis of dental arch form changes in class II patients treated with clear aligners. J Orofac Orthop. 2020 Jul;81(4):229-238. doi: 10.1007/s00056-020-00224-8. Epub 2020 Apr 14.

  PMID: 32291482 BACKGROUND

• Liu X, Cheng Y, Qin W, Fang S, Wang W, Ma Y, Jin Z. Effects of upper-molar distalization using clear aligners in combination with Class II elastics: a three-dimensional finite element analysis. BMC Oral Health. 2022 Dec 1;22(1):546. doi: 10.1186/s12903-022-02526-2.

  PMID: 36456944 BACKGROUND

• Baccetti T, Franchi L, McNamara JA Jr. An improved version of the cervical vertebral maturation (CVM) method for the assessment of mandibular growth. Angle Orthod. 2002 Aug;72(4):316-23. doi: 10.1043/0003-3219(2002)0722.0.CO;2.

  PMID: 12169031 BACKGROUND

• Marshall SD, Caspersen M, Hardinger RR, Franciscus RG, Aquilino SA, Southard TE. Development of the curve of Spee. Am J Orthod Dentofacial Orthop. 2008 Sep;134(3):344-52. doi: 10.1016/j.ajodo.2006.10.037.

  PMID: 18774080 BACKGROUND

• Fawaz P, Amm E, Khoury E. The curve of Spee and its levelling in different vertical skeletal patterns: A 3D set-up study. Int Orthod. 2021 Dec;19(4):659-668. doi: 10.1016/j.ortho.2021.08.003. Epub 2021 Aug 31.

  PMID: 34479824 BACKGROUND

• Adel SM, Vaid NR, El-Harouni N, Kassem H, Zaher AR. Digital model superimpositions: are different software algorithms equally accurate in quantifying linear tooth movements? BMC Oral Health. 2022 Mar 31;22(1):103. doi: 10.1186/s12903-022-02129-x.

  PMID: 35361187 BACKGROUND

MeSH Terms

Conditions

Malocclusion, Angle Class II; Overbite

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Bart VANDE VANNET

  Central Hospital, Nancy, France

  STUDY DIRECTOR

Central Study Contacts

Bart VANDE VANNET, Phd

CONTACT

+32496284339; bart.vande-vannet@univ-lorraine.fr

Lou DEON

CONTACT

+33685327891; loudeon@yahoo.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 13, 2023
• First Posted: May 10, 2023
• Study Start: September 30, 2024
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: July 23, 2024

Record last verified: 2024-07

Locations

FR (1)