Clinical trial NCT05853211: Therapeutic Effects of Class II Elastics on Aligners in Different Vertical Skeletal Patterns
Official title: Therapeutic Effects of Class II Elastics on Aligners in Different Vertical Skeletal Patterns in Adult Patients: Retrospective Study.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
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
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2023-05-10
Enrollment: 80
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult with class II malocclusion treated with class II elastics

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in IMPA Mandibular incisor angle (degrees)
timeFrame: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months.
Secondary outcomes:
measure: Sex
timeFrame: 1 month
measure: Duration of treatment
timeFrame: 24 months
measure: Change in interproximal dental size
timeFrame: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
measure: Change in skeletal sagittal pattern ANB angle
timeFrame: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
measure: Change in skeletal sagittal pattern Ao-Bo
timeFrame: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
measure: Change in skeletal vertical pattern : FMA
timeFrame: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
measure: Change in skeletal vertical pattern : Sn Gogn
timeFrame: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
measure: Change in faciale anterior height
timeFrame: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
measure: Change in faciale posterior height
timeFrame: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
measure: Change in index Faciale height
timeFrame: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
measure: Change in nterincisal angle
timeFrame: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
measure: Change in plan of occlusion
timeFrame: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
measure: Age at the beginning of treatment
timeFrame: 1 month
measure: Age at the end of treatment
timeFrame: 24 months
measure: Change in von Spee curve
timeFrame: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
measure: Change in overall crowding
timeFrame: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
measure: Change in overjet
timeFrame: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
measure: Change in overbite
timeFrame: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
measure: Change in arch length
timeFrame: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
measure: CHange in class II quantity
timeFrame: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
measure: Change in space required
timeFrame: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
measure: Change in inter canine distance
timeFrame: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
measure: Change in inter premolar distance
timeFrame: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
measure: Change in inter molar distance
timeFrame: First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months
Other outcomes:
Locations:
city: Nancy
country: France
facility: DEON
state: Lorraine
Study officials:
affiliation: Central Hospital, Nancy, France
name: Bart VANDE VANNET
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.