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

Malocclusion, Angle Class II Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05853211
• Other study ID #: 2023PI022
• Status: Not yet recruiting
• Start date: May 30, 2024
• Est. completion date: July 1, 2024

Study information

• Verified date: April 2024
• Source: Central Hospital, Nancy, France
• Contact: Bart VANDE VANNET, Phd
• Phone: +32496284339
• Email: bart.vande-vannet[@]univ-lorraine.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: July 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malocclusion
• Malocclusion, Angle Class II

Intervention

Combination Product:
• Aligner and inter-arch elastics
Correction of class II malocclusion by class II elastics on clear aligners

Locations

Country	Name	City	State
France	DEON	Nancy	Lorraine

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

References & Publications (14)

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. — View Citation

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. — View 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. — View 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. Erratum In: J Orofac Orthop. 2020 Nov;81(6):447. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Sex	Sex	1 month
Secondary	Duration of treatment	Treatment time duration in month	24 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Age at the beginning of treatment	Age	1 month
Secondary	Age at the end of treatment	Age	24 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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