A Single-Centered, Randomized, Double blinded, controlled trial to Evaluate The Analgesic Effect of Naproxen and Tramadol in Reducing Post-Operative Endodontic Pain in Single-Visit Endodontic Treatment of Asymptomatic Vital Anterior Teeth.

Date

2012-8

Type

Master Thesis

Thesis title

Author(s)

Khaled Ali K. Elhenshiri

Abstract

Introduction Post-operative pain following root canal treatment (RCT) is a critical concern, often stemming from periapical inflammation. Non-steroidal anti-inflammatory drugs (NSAIDs) are standardly employed, yet the comparative efficacy of potent NSAIDs versus weak opioid analgesics in this specific context remains under-investigated. This study aimed to compare the effectiveness of a single oral dose of Naproxen (NSAID) and Tramadol (weak opioid) against a placebo for reducing post-obturation pain after single-visit non-surgical endodontic treatment of asymptomatic vital anterior teeth. Methods This was a single-center, randomized, double-blinded, placebo-controlled clinical trial. Healthy individuals aged 20 to 50 years undergoing single-appointment non-surgical RCT on asymptomatic vital anterior teeth were randomly allocated into three treatment arms: Naproxen 500mg, Tramadol 100mg, or lactose placebo. The assigned medication was administered immediately post-operatively. The primary outcome, post-operative pain reduction, was measured using a Visual Analog Scale (VAS) from baseline (treatment completion) over a four-day observation period. All endodontic procedures adhered to a standardized protocol performed by trained endodontists. Results Analysis of the post-operative pain scores revealed a statistically significant difference among the three groups at the 24-hour time point ($P < 0.05$). Specifically, the Naproxen 500mg group reported the lowest mean pain scores, demonstrating superior analgesic efficacy compared to both the Tramadol 100mg and placebo groups. The pain reduction achieved by the Tramadol 100mg group was observed to be moderate but was not statistically different from the lactose placebo group ($P > 0.05$). The incidence of severe pain was lowest in the Naproxen group. Conclusion A single oral dose of Naproxen 500mg is significantly more effective than both Tramadol 100mg and a lactose placebo in managing post-operative pain following single-appointment root canal treatment of asymptomatic vital anterior teeth. These results strongly endorse the use of Naproxen (an NSAID) as a preferred first-line analgesic over Tramadol (a weak opioid) for effective pain control in this common endodontic procedure, leading to the rejection of the null hypothesis