Revista de Odontologia da UNESP
https://revodontolunesp.com.br/article/doi/10.1590/1807-2577.20260004
Revista de Odontologia da UNESP
Review Article

Proposta de termo de consentimento livre e esclarecido para o tratamento ortodôntico com alinhadores no contexto do consultório odontológico

Proposed informed consent form for orthodontic clear aligner treatment in the dental office

Marcia Yuri KAWAUCHI; Eduardo Alvares DAINESI; Antônio do Rêgo CASTELO-BRANCO FILHO; Ricardo Henrique Alves da SILVA

Downloads: 0
Views: 9

Resumo

Resumo: Introdução: Diante das exigências ético-legais de transparência e informação ao paciente, este trabalho propõe um modelo de Termo de Consentimento Livre e Esclarecido (TCLE) específico para o tratamento ortodôntico com alinhadores, destinado ao uso no consultório odontológico, distinto dos modelos voltados à pesquisa científica.

Objetivo: Propor um TCLE para o tratamento com alinhadores ortodônticos na prática clínica odontológica.

Material e método: A elaboração do termo baseou-se em revisão integrativa da literatura, conduzida a partir da pergunta norteadora: “Quais são as evidências científicas disponíveis sobre indicações, conduta clínica, cuidados e possíveis situações indesejadas no tratamento ortodôntico com alinhadores, relevantes para a elaboração de um TCLE para uso clínico?” As buscas foram realizadas nas bases de dados PubMed e BVS (Biblioteca Virtual em Saúde), considerando publicações dos últimos cinco anos.

Resultado: Foram selecionados 33 artigos, sendo 29 revisões sistemáticas e quatro textos completos. As revisões sistemáticas referiram-se aos procedimentos com alinhadores ortodônticos e os textos completos ao emprego de termo de consentimento na ortodontia. Os principais aspectos utilizados para a elaboração do TCLE foram indicação, conduta clínica, cuidados e as possíveis situações indesejadas.

Conclusão: Com base no conhecimento atual, o TCLE proposto compreende os principais pontos encontrados na literatura de forma simples e clara, além de permitir aos cirurgiões-dentistas individualizá-lo de acordo com cada paciente e suas particularidades. O documento contempla, ainda, orientações sobre o uso do Termo de Assentimento Livre e Esclarecido (TALE) para pacientes menores de idade.

Palavras-chave

Aparelho ortodôntico removível; alinhadores transparentes; ortodontia; termo de consentimento

Abstract

Abstract: Introduction: In light of the ethical and legal requirements for transparency and patient information, this study proposes a model Informed Consent Form (ICF) specifically for orthodontic treatment with aligners. This document is intended for clinical use in dental practices, distinguishing it from models designed for scientific research.

Objective: To propose an ICF for orthodontic aligner treatment in clinical dental practice.

Material and method: The development of the form was based on an integrative literature review guided by the question: "What scientific evidence is available regarding indications, clinical management, care, and potential adverse situations in orthodontic aligner treatment that are relevant to the development of an ICF for clinical use?" Searches were conducted in the PubMed and VHL (Virtual Health Library) databases, considering publications from the last five years.

Result: Thirty-three articles were selected, consisting of 29 systematic reviews and four full-text articles. The systematic reviews addressed procedures involving orthodontic aligners, while the full-text articles focused on the use of informed consent in orthodontics. The primary aspects utilized to draft the ICF were indications, clinical management, care, and potential adverse situations.

Conclusion: Based on current knowledge, the proposed ICF encompasses the main points identified in the literature in a simple and clear manner, while allowing dental surgeons to individualize the document according to each patient’s specific needs. Furthermore, the document includes guidelines on the use of the Informed Consent Term of Assent (TA) for minor patients.
 

Keywords

Orthodontic appliances removable; clear aligners; orthodontic; consent form

References

1 Brasil. Conselho Federal de Odontologia. Resolução CFO nº 118, de 11 de maio de 2012. Aprova o Código de Ética Odontológica. Diário Oficial da União. Brasília, 2012. Disponível em: https://website.cfo.org.br/wp-content/uploads/2012/07/codigo_etica_Atual.pdf. Acesso em: 8 out. 2025.

2 Brasil. Lei nº 8.078, de 11 de setembro de 1990. Dispõe sobre a proteção do consumidor e dá outras providências. Diário Oficial da União. Brasília, 1990. Disponível em: https://www.planalto.gov.br/ccivil_03/leis/l8078compilado.htm. Acesso em: 8 out. 2025.

3 Turra PHG, Silva RHA, Pinto PHV. Preenchedores faciais à base de ácido hialurônico: proposta de termo de consentimento livre e esclarecido. Aesthetic Orofacial Science. 2023;4(2):24-32. https://doi.org/10.51670/aos.v4i2.153.

4 Picoli FF, Franco A, Mundim-Picoli MBV, Paranhos LR, Silva RF. Why are Brazilian orthodontists prosecuted and convicted? An overview of the contemporary jurisprudence. Biosci J. 2020;36(5):1806-15. https://doi.org/10.14393/BJ-v36n5a2020-51168.

5 Desman AR, Fields HW, Ni A, Robinson FG, Skulski B, Firestone AR, et al. Rehearsal’s effect on long-term recall and comprehension of orthodontic informed consent. Am J Orthod Dentofacial Orthop. 2022 Feb;161(2):e114-26. https://doi.org/10.1016/j.ajodo.2021.06.013. PMid:34625316.

6 Skulski BN, Fields HW, Johnston WM, Robinson FG, Firestone A, Heinlein DJ. Rehearsal’s effect on recall and comprehension of orthodontic informed consent. Am J Orthod Dentofacial Orthop. 2021 Apr;159(4):e331-41. https://doi.org/10.1016/j.ajodo.2020.09.026. PMid:33573895.

7 Meade MJ, Dreyer CW. Orthodontic treatment consent forms: a readability analysis. J Orthod. 2022 Mar;49(1):32-8. https://doi.org/10.1177/14653125211033301. PMid:34325567.

8 Prado N, Waring D. Improving the orthodontic consent process: amending hospital policy and implementing change. J Orthod. 2019 Mar;46(1):34-8. https://doi.org/10.1177/1465312518815547. PMid:31056063.

9 Tiol-Carrillo A. Aspectos legales del consentimiento informado en odontología. Rev ADM. 2021;78(2):80-3. https://doi.org/10.35366/99282.

10 Meade MJ, Jensen S, Ju X, Hunter D, Jamieson L. Clear aligner therapy informed consent forms: A quality and readability evaluation. Int Orthod. 2024;22(2):100873. https://doi.org/10.1016/j.ortho.2024.100873. PMid:38713930.

11 Bakdach WMM, Haiba M, Hadad R. Changes in surface morphology, chemical and mechanical properties of clear aligners during intraoral usage: a systematic review and meta-analysis. Int Orthod. 2022 Mar;20(1):100610. https://doi.org/10.1016/j.ortho.2022.100610. PMid:35090857.

12 Nucera R, Dolci C, Bellocchio AM, Costa S, Barbera S, Rustico L, et al. Effects of composite attachments on orthodontic clear aligners therapy: a systematic review. Materials (Basel). 2022 Jan;15(2):533. https://doi.org/10.3390/ma15020533. PMid:35057250.

13 Brasil. Constituição. Constituição da República Federativa do Brasil de 1988. Brasília, DF: Presidência da República; 1988. Disponível em: https://www.planalto.gov.br/ccivil_03/constituicao/constituicao.htm. Acesso em: 8 out. 2025.

14 Iliadi A, Koletsi D, Eliades T. Forces and moments generated by aligner-type appliances for orthodontic tooth movement: a systematic review and meta-analysis. Orthod Craniofac Res. 2019 Nov;22(4):248-58. https://doi.org/10.1111/ocr.12333. PMid:31237410.

15 Galan-Lopez L, Barcia-Gonzalez J, Plasencia E. A systematic review of the accuracy and efficiency of dental movements with invisalign®. Korean J Orthod. 2019 May;49(3):140-9. https://doi.org/10.4041/kjod.2019.49.3.140. PMid:31149604.

16 Shrivastava A, Mohanty P, Dash BP, Jena S, Sahoo N. Proficiency of clear aligner therapy: a systematic review and meta-analysis. Cureus. 2023 Sep;15(9):e45072. https://doi.org/10.7759/cureus.45072. PMid:37842499.

17 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):133-42. https://doi.org/10.1111/ocr.12353. PMid:31651082.

18 Brasil. Lei nº 10.406, de 10 de janeiro de 2002. Diário Oficial da União. Brasília, 2002. Disponível em: https://www.planalto.gov.br/ccivil_03/leis/2002/l10406compilada.htm. Acesso em: 8 out. 2025.

19 Putrino A, Barbato E, Galluccio G. Clear aligners: between evolution and efficiency-a scoping review. Int J Environ Res Public Health. 2021 Mar;18(6):2870. https://doi.org/10.3390/ijerph18062870. PMid:33799682.

20 Crego-Ruiz M, Jorba-García A. Assessment of the periodontal health status and gingival recession during orthodontic treatment with clear aligners and fixed appliances: a systematic review and meta-analysis. Med Oral Patol Oral Cir Bucal. 2023 Jul;28(4):e330-40. https://doi.org/10.4317/medoral.25760. PMid:36641738.

21 Llera-Romero AS, Adobes-Martín M, Iranzo-Cortés JE, Montiel-Company JM, Garcovich D. Periodontal health status, oral microbiome, white-spot lesions and oral health related to quality of life-clear aligners versus fixed appliances: a systematic review, meta-analysis and meta-regression. Korean J Orthod. 2023 Nov;53(6):374-92. https://doi.org/10.4041/kjod22.272. PMid:37989575.

22 Kaklamanos EG, Makrygiannakis MA, Athanasiou AE. Oral health-related quality of life throughout treatment with clear aligners in comparison to conventional metal fixed orthodontic appliances: a systematic review. Int J Environ Res Public Health. 2023 Feb;20(4):3537. https://doi.org/10.3390/ijerph20043537. PMid:36834235.

23 Zhang B, Huang X, Huo S, Zhang C, Zhao S, Cen X, et al. Effect of clear aligners on oral health-related quality of life: A systematic review. Orthod Craniofac Res. 2020 Nov;23(4):363-70. https://doi.org/10.1111/ocr.12382. PMid:32340082.

24 Oikonomou E, Foros P, Tagkli A, Rahiotis C, Eliades T, Koletsi D. Impact of aligners and fixed appliances on oral health during orthodontic treatment: a systematic review and meta-analysis. Oral Health Prev Dent. 2021 Dec;19:659-72. https://doi.org/10.3290/j.ohpd.b2403661. PMid:34874143.

25 Di Spirito F, D’Ambrosio F, Cannatà D, D’Antò V, Giordano F, Martina S. Impact of clear aligners versus fixed appliances on periodontal status of patients undergoing orthodontic treatment: a systematic review of systematic reviews. Healthcare (Basel). 2023 May;11(9):1340. https://doi.org/10.3390/healthcare11091340. PMid:37174882.

26 Gallucio G. Is the use of clear aligners a real critical change in oral health prevention and treatment? Clin Ter. 2021 Mar;172(2):113-5. https://doi.org/10.7417/CT.2021.2295. PMid:33763672.

27 Ma S, Wang Y. Clinical outcomes of arch expansion with Invisalign: a systematic review. BMC Oral Health. 2023 Aug;23(1):587. https://doi.org/10.1186/s12903-023-03302-6. PMid:37620781.

28 Bouchant M, Saade A, El Helou M. Is maxillary arch expansion with Invisalign® efficient and predictable? A systematic review. Int Orthod. 2023 Jun;21(2):100750. https://doi.org/10.1016/j.ortho.2023.100750. PMid:36989750.

29 Gonçalves A, Collard A, Monteiro F, Matos D, Carvalho Ó, Azevedo R, et al. Accuracy of Invisalign®on upper incisors: a systematic review. Turk J Orthod. 2023 Jun;36(2):126-33. https://doi.org/10.4274/TurkJOrthod.2022.2021.0254. PMid:37346374.

30 Padmanabhan A, Khan Y, Lambate VKU, Naveed N, Singh M, et al. Efficacy of clear aligners in treating Class III malocclusion with mandibular molar distalization: a systematic review. Cureus. 2023 Nov;15(11):e48134. https://doi.org/10.7759/cureus.48134. PMid:38046776.

31 Inchingolo AM, Inchingolo AD, Carpentiere V, Del Vecchio G, Ferrante L, Di Noia A, et al. Predictability of dental distalization with clear aligners: a systematic review. Bioengineering (Basel). 2023 Dec;10(12):1390. https://doi.org/10.3390/bioengineering10121390. PMid:38135981.

32 Jaber ST, Hajeer MY, Sultan K. Treatment effectiveness of clear aligners in correcting complicated and severe malocclusion cases compared to fixed orthodontic appliances: a systematic review. Cureus. 2023 Apr;15(4):e38311. https://doi.org/10.7759/cureus.38311. PMid:37128600.

33 Iliadi A, Koletsi D, Papageorgiou SN, Eliades T. Safety considerations for thermoplastic-type appliances used as orthodontic aligners or retainers. A systematic review and meta-analysis of clinical and in-vitro research. Materials (Basel). 2020 Apr;13(8):1843. https://doi.org/10.3390/ma13081843. PMid:32295303.

34 Peter E, Monisha J, George SA. Bisphenol-A release from thermoplastic clear aligner materials: a systematic review. J Orthod. 2023 Sep;50(3):276-86. https://doi.org/10.1177/14653125231160570. PMid:36922722.

35 Yazdi M, Daryanavard H, Ashtiani AH, Moradinejad M, Rakhshan V. A systematic review of biocompatibility and safety of orthodontic clear aligners and transparent vacuum-formed thermoplastic retainers: Bisphenol-A release, adverse effects, cytotoxicity, and estrogenic effects. Dent Res J (Isfahan). 2023 Mar;20(1):41. https://doi.org/10.4103/1735-3327.372658. PMid:37180685.

36 Fang X, Qi R, Liu C. Root resorption in orthodontic treatment with clear aligners: a systematic review and meta-analysis. Orthod Craniofac Res. 2019 Nov;22(4):259-69. https://doi.org/10.1111/ocr.12337. PMid:31323701.

37 Gandhi V, Mehta S, Gauthier M, Mu J, Kuo CL, Nanda R, et al. Comparison of external apical root resorption with clear aligners and pre-adjusted edgewise appliances in non-extraction cases: a systematic review and meta-analysis. Eur J Orthod. 2021 Jan;43(1):15-24. https://doi.org/10.1093/ejo/cjaa013. PMid:32077935.

38 Li Q, Du Y, Yang K. Comparison of pain intensity and impacts on oral health-related quality of life between orthodontic patients treated with clear aligners and fixed appliances: a systematic review and meta-analysis. BMC Oral Health. 2023 Nov;23(1):920. https://doi.org/10.1186/s12903-023-03681-w. PMid:38001455.

39 Cardoso PC, Espinosa DG, Mecenas P, Flores-Mir C, Normando D. Pain level between clear aligners and fixed appliances: a systematic review. Prog Orthod. 2020 Jan;21(1):3. https://doi.org/10.1186/s40510-019-0303-z. PMid:31956934.

40 Raghavan S, Abu Alhaija ES, Duggal MS, Narasimhan S, Al-Maweri SA. White spot lesions, plaque accumulation and salivary caries-associated bacteria in clear aligners compared to fixed orthodontic treatment. A systematic review and meta- analysis. BMC Oral Health. 2023 Aug;23(1):599. https://doi.org/10.1186/s12903-023-03257-8. PMid:37635207.

41 Ali Baeshen H, El-Bialy T, Alshehri A, Awadh W, Thomas J, Dhillon H, et al. The effect of clear aligners on speech: a systematic review. Eur J Orthod. 2023 Feb;45(1):11-9. https://doi.org/10.1093/ejo/cjac018. PMid:35522548.
 


Submitted date:
01/29/2026

Accepted date:
04/14/2026

6a4baef6a953952a683243b7 rou Articles
Links & Downloads

Rev. odontol. UNESP

Share this page
Page Sections