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.
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.
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 |
Country | Name | City | State |
---|---|---|---|
France | DEON | Nancy | Lorraine |
Lead Sponsor | Collaborator |
---|---|
Central Hospital, Nancy, France |
France,
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
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06297109 -
Maxillary Patient Specific Implants in Bimaxillary Orthognathic Surgery
|
N/A | |
Recruiting |
NCT05227469 -
Myofunctional Therapy Twin Block
|
N/A | |
Completed |
NCT05356780 -
Predictability of Orthodontic Tooth Movement With Invisalign Aligners
|
||
Not yet recruiting |
NCT05467579 -
Mandibular Advancement Clear Aligner Treatment in Juvenile Idiopathic Arthritis Subjects
|
N/A | |
Completed |
NCT01530516 -
Crossbow Versus Forsus Springs in Mild to Moderate Class II Malocclusion Cases
|
N/A | |
Recruiting |
NCT04875104 -
Upper Sequential Distalization With TADs and Aligners
|
N/A | |
Completed |
NCT04175405 -
Low-level Laser Therapy With a 635nm Diode Laser on Orthodontic Mini-implants Stability.
|
N/A | |
Completed |
NCT02456220 -
Dentoskeletal Changes Associated With Herbst Appliance Therapy
|
N/A | |
Recruiting |
NCT05950581 -
Treatment of Skeletal Class II Malocclusion With Modified Twin-Block Appliance With Clear Plates
|
N/A | |
Completed |
NCT03645343 -
The Effect of Functional Treatment of Patients With Backward Positioned Chins on the Jaw Joint and Movements
|
N/A | |
Completed |
NCT04276402 -
Effect of Photobiomodulation by 808nm Diode Laser on the Stability of Orthodontic Mini-implants.
|
N/A | |
Completed |
NCT03239912 -
Treatment of Class II Malocclusion Combined With Low-level Laser
|
N/A | |
Recruiting |
NCT03773783 -
Study to Compare Two Functional Appliances for Class II Malocclusions
|
N/A | |
Recruiting |
NCT05499221 -
Bone Anchored Carriere Motion Appliance
|
N/A | |
Completed |
NCT03159962 -
Mandibular Response After Maxillary Orthopedic Expansion in Class II Growing Subjects
|
N/A | |
Active, not recruiting |
NCT02010346 -
The Effect of Timing on Orthodontic Treatment
|
N/A | |
Completed |
NCT06240923 -
"Three Dimensional Assessment of Maxillary Molars Following Distalization Using Two Different Approaches"
|
N/A | |
Completed |
NCT05298280 -
Vertical Effects in Class II Patients Treated With Distalization
|
N/A | |
Completed |
NCT04556448 -
RCT Comparing Invisalign and Traditional Orthodontic Treatment
|
N/A | |
Completed |
NCT03455634 -
Predictors Associated With Seeking Orthodontic Treatment, Compliance and Treatment Success
|
N/A |