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

Therapeutic Effects of Class II Elastics on Aligners in Different Vertical Skelettal Patterns in Adult Patients: Retrospective Study.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Malocclusion, Angle Class II
• Intervention / Treatment: Combination product: Aligner and inter-arch elastics

Detailed Description

It is a non-interventional research involving the human person, research on existing data and / samples in the field of dentofacial orthopedics. This study analyzes the effects of rubber bands when combined with aligners in adult patients. This is a comparative retrospective study of radiographs and casts before and after orthodontic treatment. The patients studied are in Angle class II and adults. Two groups are analysed: patients treated with fixed (vestibular multi-attachment) and removable (Invisalign-type aligners) appliances.

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Bart VANDE VANNET, PhD; Phone Number: +32496284339; Email: bart.vande-vannet@univ-lorraine.fr
• Study Contact Backup: Name: Lou DEON; Phone Number: +33685327891; Email: loudeon@yahoo.fr

Study Locations

• France
  • Lorraine
    • Nancy, Lorraine, France, 54000
      • DEON
      • Contact: Lou DEON, Student; Phone Number: +33685327891; Email: loudeon@yahoo.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Adult with class II malocclusion treated with class II elastics

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Clear aligner; Patient with class II malocclusion, treated with class II elastics on aligners	Combination product: Aligner and inter-arch elastics; Correction of class II malocclusion by class II elastics on clear aligners
Fixed appliance; Patient with class II malocclusion, treated with class II elastics on fixed appliance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sex	Sex	1 month
Duration of treatment	Treatment time duration in month	24 months
Change in interproximal dental size	Interproximal size in mm	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	Cephalometric measurements : angle between A, Na (nasion) and B in degrees	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	Cephalometric measurements : mesure in mm between Ao and Bo	First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Change in skeletal vertical pattern : FMA	Cephalometric measurements : angle in degrees between franckfort plan and mandibular plan.	First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Change in skeletal vertical pattern : Sn Gogn	Cephalometric measurements : angle in degrees between SN and GoGn	First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Change in faciale anterior height	Cephalometric measurements of faciale anterior height	First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Change in faciale posterior height	Cephalometric measurements of faciale posterior height	First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Change in index Faciale height	Cephalometric measurements, index HFP (faciale posterior heigth)/ HFA (faciale anterior height)	First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Change in nterincisal angle	Cephalometric measurements : measurement between manxillary and mandibular incisors.	First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Change in plan of occlusion	Cephalometric measurements : angle between SN and Op	First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Age at the beginning of treatment	Age	1 month
Age at the end of treatment	Age	24 months
Change in von Spee curve	Measurements on impressions : it is the average of the distance between the highest point of the deepest cusp and the occlusal plane.	First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Change in overall crowding	Measurements on impressions : comparison of the sum of the mesiodistal diameters of 35 to 45 and the arch perimeter from the mesial face of 36 to the mesial face of 46.	First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Change in overjet	Measurements on impressions : in mm	First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Change in overbite	Measurements on impressions : in mm	First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Change in arch length	Measurements on impressions : distance between inter incisal point and mesiale face of 6.	First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
CHange in class II quantity	Measurements on impressions : inter canine and inter molar relations	First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Change in space required	Measurements on impressions : sum of all mesiodistal diameter.	First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Change in inter canine distance	Measurements on impressions : distance between the canine in mm	First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Change in inter premolar distance	Measurements on impressions : distance between the premolars	First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Change in inter molar distance	Measurements on impressions : distance between the molars	First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Investigators: Study Director: Bart VANDE VANNET, Central Hospital, Nancy, France

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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. Erratum In: J Orofac Orthop. 2020 Nov;81(6):447.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): May 30, 2024
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: April 13, 2023
• First Submitted That Met QC Criteria: May 8, 2023
• First Posted (Actual): May 10, 2023

Study Record Updates

• Last Update Posted (Actual): April 30, 2024
• Last Update Submitted That Met QC Criteria: April 29, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: adult; orthodontic; Invisalign; orthodontic appliance; aligner; inter-arch elastic; class II malocclusion; clear aligner; class II elastics; angle class II malocclusion
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion; Malocclusion, Angle Class II; Overbite
• Other Study ID Numbers: 2023PI022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No