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Study aim
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Determine the effect of Naproxen patch on relieving orthodontic pain by evaluation of VAS and IL-1β inflammatory factor
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Design
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Split-mouth triple-blind clinical trial
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Settings and conduct
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In this split-mouth triple-blind clinical trial, for 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 on 2 & 6 hours, sleep time, 24 hours, days 2, 3 and 7 by the patients using 100 mm VAS. Levels of IL-1β in GCF were evaluated by ELISA at baseline, 1 and 24 hours and 7 days. Paired samples t and two-way repeated measures ANOVA analysis of variance tests with a significance level of 0.05 were applied.
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Participants/Inclusion and exclusion criteria
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The inclusion criteria were: Generally healthy patients, No periodontal or endodontic disease, Presence of bilateral first and second maxillary molars and second maxillary premolars, Tight posterior teeth contacts with no spacing, Presence of antagonist teeth without posterior open bite, No psychologic or mental disorder. Patients who did not participate in the follow-up sessions, had no pain on both sides, took systemic or topical painkillers except prescribed patches, removed separators, did not use patches as prescribed, and did not fill VAS questionnaire on time or lacked cooperation were excluded.
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Intervention groups
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5% Naproxen or placebo patches were randomly placed on the upper right or left first molars every 8 hours.
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Main outcome variables
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The pain related to the orthodontic tooth movement is common and cause dissatisfaction and discomfort. The present study aimed to compare the efficacy of Naproxen patch in pain control during orthodontic tooth separation by the Visual Analogue Scale (VAS) and Interleukin 1β (IL-1β) levels of Gingival Crevicular Fluid (GCF).