The effect of naproxen patches on relieving orthodontic pain by evaluation of VAS and IL-1β inflammatory factor: a split-mouth study

ABSTRACT Introduction: Pain related to orthodontic tooth movement is common and cause dissatisfaction and discomfort. Objective: The present study aimed to compare the efficacy of naproxen patches in pain control during orthodontic tooth separation, by means of visual analogue scale (VAS) and interleukin 1β (IL-1β) levels in gingival crevicular fluid (GCF). Methods: In this split-mouth triple-blind clinical trial, with 40 patients following separation, 5% naproxen or placebo patches were randomly placed on the upper right or left first molars every 8 hours. Pain intensity scores were determined after 2 and 6 hours, sleep time, 24 hours, days 2, 3 and 7 by the patients using a 100-mm VAS ruler. IL-1β levels in GCF were evaluated by ELISA at baseline, 1 and 24 hours and 7 days. Paired samples t-tests and two-way repeated measures ANOVA analysis of variance with a significance level of 0.05 were applied. Results: A total number of 30 patients (13 males and 17 females) finished the trial. Significant differences were found in pain scores (p< 0.0001) and IL-1β levels (p= 0.047) between naproxen and placebo groups. Lower pain scores were reported for the patients using naproxen patches at all time points, except 1 hour after separation. IL-1β levels were lower for the patients using naproxen patches only 1 hour after separation (p= 0.047). The peak of pain scores and IL-1β levels were calculated at 24 hours. Conclusion: In the light of VAS scores and IL-1β levels, naproxen patches reduced the pain caused by separator placement.

RESUMO Introdução: a dor relacionada à movimentação dentária ortodôntica é comum e causa insatisfação e desconforto. Objetivo: o presente estudo teve como objetivo avaliar a eficácia de curativos de naproxeno no controle da dor durante a separação ortodôntica dos dentes, por meio de escalas visuais analógicas (EVA) e dos níveis de interleucina 1β (IL-1β) no fluido crevicular gengival (FCG). Métodos: neste ensaio clínico, triplo-cego, boca dividida, com 40 pacientes após a separação dos dentes, foram aplicados, de forma aleatória, curativos com naproxeno a 5% ou placebo, nos primeiros molares superiores, direito ou esquerdo, a cada 8 horas. Os escores de intensidade da dor foram registrados pelos pacientes após 2 e 6 horas, durante o sono, após 24 horas, 2, 3 e 7 dias, usando uma EVA de 100 mm. Os níveis de IL-1β no FCG foram avaliados pelo ELISA no momento inicial, e após 1 e 24 horas e 7 dias. Foram aplicados testes t para amostras pareadas e ANOVA de duas vias para medidas repetidas, com nível de significância de 0,05. Resultados: no total, 30 pacientes (13 homens e 17 mulheres) terminaram o ensaio clínico. Diferenças significativas foram encontradas nos escores de dor (p< 0,0001) e níveis de IL-1β (p= 0,047) entre os grupos naproxeno e placebo. Índices mais baixos de dor foram relatados pelos pacientes que usaram curativos de naproxeno em todos os tempos avaliados, com exceção de 1 hora após a separação. Os níveis de IL-1β foram menores nos pacientes que usaram os curativos de naproxeno apenas 1 'hora após a separação (p= 0,047). Os picos dos escores de dor e dos níveis de IL-1β foram registrados 24 horas após a separação. Conclusão: considerando-se os escores das EVAs e os níveis de IL-1β, pode-se concluir que os curativos de naproxeno reduziram a dor causada pela instalação dos separadores ortodônticos.

The effect of naproxen patches on relieving orthodontic pain by evaluation of VAS and IL-1ß inflammatory factor: a split-mouth study.

INTRODUCTION: Pain related to orthodontic tooth movement is common and cause dissatisfaction and discomfort. Objective: The present study aimed to compare the efficacy of naproxen patches in pain control during orthodontic tooth separation, by means of visual analogue scale (VAS) and interleukin 1ß (IL-1ß) levels in gingival crevicular fluid (GCF). METHODS: In this split-mouth triple-blind clinical trial, with 40 patients following separation, 5% naproxen or placebo patches were randomly placed on the upper right or left first molars every 8 hours. Pain intensity scores were determined after 2 and 6 hours, sleep time, 24 hours, days 2, 3 and 7 by the patients using a 100-mm VAS ruler. IL-1ß levels in GCF were evaluated by ELISA at baseline, 1 and 24 hours and 7 days. Paired samples t-tests and two-way repeated measures ANOVA analysis of variance with a significance level of 0.05 were applied. RESULTS: A total number of 30 patients (13 males and 17 females) finished the trial. Significant differences were found in pain scores (p< 0.0001) and IL-1ß levels (p= 0.047) between naproxen and placebo groups. Lower pain scores were reported for the patients using naproxen patches at all time points, except 1 hour after separation. IL-1ß levels were lower for the patients using naproxen patches only 1 hour after separation (p= 0.047). The peak of pain scores and IL-1ß levels were calculated at 24 hours. CONCLUSION: In the light of VAS scores and IL-1ß levels, naproxen patches reduced the pain caused by separator placement.