• Oral Surg Oral Med O · Oct 1997

    Randomized Controlled Trial Comparative Study Clinical Trial

    Sustained relief of oral aphthous ulcer pain from topical diclofenac in hyaluronan: a randomized, double-blind clinical trial.

    • M A Saxen, W T Ambrosius, Rehemtula al-KF, A L Russell, and G J Eckert.
    • Department of Oral Surgery, Medicine and Pathology, Indiana University School of Dentistry, Indianapolis, Ind., USA.
    • Oral Surg Oral Med O. 1997 Oct 1; 84 (4): 356-61.

    ObjectivesThe purpose of this study was to test the hypothesis that topically applied 3% diclofenac in 2.5% hyaluronan reduces aphthous ulcer pain.Study DesignA randomized, double-blind, single dose study of 60 healthy adults with aphthous ulcers in three treatment groups--3% diclofenac in 2.5% hyaluronan, 2.5% hyaluronan, 3% viscous lidocaine--was undertaken. Visual analogue scale pain scores were obtained before and after gel application and hourly, for up to 8 hours after gel application. Statistical analysis was performed with repeated measures ANOVA with square root transformation and Bonferroni correction.ResultsA 48% overall reduction in pain (p < 0.01) was observed 10 minutes after gel application; however, no significant difference was found between the three topical agents. A 35% to 52% pain reduction (p < 0.01) was reported 2 to 6 hours after the application of diclofenac in hyaluronan, whereas hyaluronan gel alone and viscous lidocaine failed to produce significant VAS reductions.ConclusionsA dose of 3% diclofenac in 2.5% hyaluronan is an effective and novel treatment for this common, painful disorder.

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