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Status unknownNCT05853211Updated Jul 23, 2024

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

An observational study in Malocclusion, Angle Class II, sponsored by Central Hospital, Nancy, France. Status unknown at 1 site in France. Open to participants aged 13 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-23.

Sponsored by Central Hospital, Nancy, France · Observational

The sponsor has not verified this record recently (last verified Jul 2024), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
80
Ages
13 Years and older
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • 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
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In context

Malocclusion, Angle Class II

127 studies on the registry are indexed under Malocclusion, Angle Class II; 18 are open to participants now.

This study's planned enrollment of 80 is above the median of 72 across 13 observational studies indexed under Malocclusion, Angle Class II.

Browse Malocclusion, Angle Class II studies →

Lead sponsor

Central Hospital, Nancy, France is the lead sponsor of 796 studies on the registry; 187 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
13 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Adult with class II malocclusion treated with class II elastics

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Incomplete data
  • Treatment with extractions, mini-screws, mini-plate or ortho-surgical treatment
  • Dental agenesis (excluding wisdom teeth)
  • Cranial-facial syndromes
05

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
80 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • Combination productAligner and inter-arch elastics

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

06

What researchers measure

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

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

Secondary outcomes

  1. Sex

    Sex

    Time frame: 1 month

  2. Duration of treatment

    Treatment time duration in month

    Time frame: 24 months

  3. Change in interproximal dental size

    Interproximal size in mm

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

  4. Change in skeletal sagittal pattern ANB angle

    Cephalometric measurements : angle between A, Na (nasion) and B in degrees

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

  5. Change in skeletal sagittal pattern Ao-Bo

    Cephalometric measurements : mesure in mm between Ao and Bo

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

  6. Change in skeletal vertical pattern : FMA

    Cephalometric measurements : angle in degrees between franckfort plan and mandibular plan.

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

  7. Change in skeletal vertical pattern : Sn Gogn

    Cephalometric measurements : angle in degrees between SN and GoGn

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

  8. Change in faciale anterior height

    Cephalometric measurements of faciale anterior height

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

  9. Change in faciale posterior height

    Cephalometric measurements of faciale posterior height

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

  10. Change in index Faciale height

    Cephalometric measurements, index HFP (faciale posterior heigth)/ HFA (faciale anterior height)

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

  11. Change in nterincisal angle

    Cephalometric measurements : measurement between manxillary and mandibular incisors.

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

  12. Change in plan of occlusion

    Cephalometric measurements : angle between SN and Op

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

  13. Age at the beginning of treatment

    Age

    Time frame: 1 month

  14. Age at the end of treatment

    Age

    Time frame: 24 months

  15. 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.

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

  16. 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.

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

  17. Change in overjet

    Measurements on impressions : in mm

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

  18. Change in overbite

    Measurements on impressions : in mm

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

  19. Change in arch length

    Measurements on impressions : distance between inter incisal point and mesiale face of 6.

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

  20. CHange in class II quantity

    Measurements on impressions : inter canine and inter molar relations

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

  21. Change in space required

    Measurements on impressions : sum of all mesiodistal diameter.

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

  22. Change in inter canine distance

    Measurements on impressions : distance between the canine in mm

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

  23. Change in inter premolar distance

    Measurements on impressions : distance between the premolars

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

  24. Change in inter molar distance

    Measurements on impressions : distance between the molars

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

07

Study locations

1 site
  • DEON
    Nancy, Lorraine 54000, France
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References and documents

Publications

  • 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. PubMed 23452973 ↗
  • 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. PubMed 31651082 ↗
  • 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. PubMed 28547915 ↗
  • 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. PubMed 30171391 ↗
  • 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. PubMed 34013659 ↗
  • 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. PubMed 26636248 ↗
  • 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. PubMed 35015923 ↗
  • 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. PubMed 36555949 ↗
  • 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. PubMed 32291482 ↗
  • 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. PubMed 36456944 ↗
  • 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. PubMed 12169031 ↗
  • 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. PubMed 18774080 ↗
  • 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. PubMed 34479824 ↗
  • 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. PubMed 35361187 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05853211
Responsible party
VANDE VANNET Bart (Professor, Central Hospital, Nancy, France) — Principal investigator
First posted
May 10, 2023
Start date
Sep 30, 2024 (estimated)
Primary completion
Oct 1, 2024 (estimated)
Completion
Oct 1, 2024 (estimated)
Last update
Jul 23, 2024

Study contacts

Bart VANDE VANNET, Phd
Contact
bart.vande-vannet@univ-lorraine.fr
+32496284339
Lou DEON
Contact
loudeon@yahoo.fr
+33685327891
Bart VANDE VANNET
study director · Central Hospital, Nancy, France

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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