Revista de Odontologia da UNESP
https://revodontolunesp.com.br/article/doi/10.1590/1807-2577.00722
Revista de Odontologia da UNESP
Original Article

A double-blinded randomized clinical trial of pain perception during orthodontic treatment

Ensaio clínico randomizado duplo cego de percepção da dor durante tratamento ortodôntico

Silvana ROSSI; Milton SANTAMARIA JUNIOR; Giovana Cherubini VENEZIAN; Carolina Carmo de MENEZES; José Eduardo Prado de SOUZA; Silvia Amélia Scudeler VEDOVELLO

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Abstract

Abstract: Introduction: Orthodontic movement can cause painful symptoms, especially in the early stages of treatment.

Objective: This study aimed to compare the performance of chewing gum and ibuprofen in pain control during the initial period of orthodontic treatment.

Material and method: A randomized blind clinical trial, with an allocation ratio of 1:1, was developed with patients aged ≥18 years old. The sample size was established considering a significance level of 5% and test power of 80%, resulting in a minimum of 30 volunteers per group (n=90). Participants were paired regarding sex, age, the severity of malocclusion, defined by the Dental Health Component (DHC) of the Index of Orthodontic Treatment Need (IOTN), and crowding, determined by Little’s irregularity index. The sample was randomly allocated to three groups: Group I (control) placebo; Group II chewing gum; and Group III Ibuprofen. Pain perception was evaluated by the Visual Analog Scale (VAS) in the first 24, 36, and 48 hours after activation of the orthodontic appliance. The data were analyzed by generalized linear models for repeated measures in time.

Result: No statistically significant difference (p>0.05) was observed among the groups for the methods of pain therapy evaluated in 24, 36, and 48 hours post-activation.

Conclusion: There was no difference among the method used for pain control during the orthodontic treatment.

Keywords

Pain, fixed orthodontic appliances, analgesics, RCT

Resumo

Resumo: Introdução: A movimentação ortodôntica pode causar sintomatologia dolorosa, principalmente nas fases iniciais do tratamento.

Objetivo: Este estudo teve como objetivo comparar o desempenho da goma de mascar e do ibuprofeno no controle da dor durante o período inicial do tratamento ortodôntico.

Material e método: Foi desenvolvido um ensaio clínico randomizado cego, com razão de alocação de 1:1, com pacientes com idade ≥18 anos. O tamanho da amostra foi estabelecido considerando um nível de significância de 5% e poder do teste de 80%, resultando em um mínimo de 30 voluntários por grupo (n=90). Os participantes foram pareados quanto ao sexo, idade, gravidade da má oclusão, definida pelo Componente de Saúde Bucal (DHC) do Índice de Necessidade de Tratamento Ortodôntico (IOTN), e apinhamento, determinado pelo índice de irregularidade de Little. A amostra foi distribuída aleatoriamente em três grupos: Grupo I (controle) placebo; Goma de mascar Grupo II; e Grupo III Ibuprofeno. A percepção da dor foi avaliada pela Escala Visual Analógica (EVA) nas primeiras 24, 36 e 48 horas após a ativação do aparelho ortodôntico. Os dados foram analisados ​​por modelos lineares generalizados para medidas repetidas no tempo.

Resultado: Não foi observada diferença estatisticamente significativa (p>0.05) entre os grupos para os métodos de terapia da dor avaliados em 24, 36 e 48 horas pós-ativação. Conclusão: Não houve diferença entre o método utilizado para controle da dor durante o tratamento ortodôntico.
 

Palavras-chave

Dor, aparelos ortodônticos fixos, analgésicos, RCT

References

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Submitted date:
02/18/2022

Accepted date:
04/11/2022

628bd8b9a9539521d40c9882 rou Articles
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