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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05853211
Other study ID # 2023PI022
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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 allClick 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
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