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[Double blind placebo-controlled study on efficacy, acceptability and safety of mouthwash diclofenac in oral or periodontal postoperative period].

BACKGROUND
In a double blind clinical study the efficacy, acceptability and safety of a mouthwash containing diclofenac 0.074% DI-CO in patients undergone to oral or periodontal surgery was evaluated compared to placebo.


METHODS
The design was a randomised double blind controlled clinical study. The patients rinsed for 1 min twice a day with diclofenac mouthwash or placebo (15 mL) at least after 1 hour since the chlorhexidine rinse for 7 days. Indistinguishable bottles and same appearance of the formulations guaranteed the reliability of the blindness. Pain at 8.00 pm the day of surgery and at 8.00 am the following day, inflammatory condition 24 hours after intervention, acceptability and safety were the parameters evaluated. Fifty (30 M, 20 F), mean aged 31.7 years, with pain score at the end of anaesthesia effect equivalent to 3.25 (semi-quantitative scale) were treated. At baseline the vital characteristics and the severity of the clinical condition were homogeneous in the two groups.


RESULTS
The mean severity score was significantly lower on DI-CO than the one showed on placebo both at 8.00 pm the day of surgery (p=0.003) and at 8.00 am the following day (p= 0.001). The gingival inflammatory condition were significantly improved by DI-CO versus placebo (p<0.001). The good safety and pleasant palatability were similar for both treatments.


CONCLUSIONS
Diclofenac mouthwash presented very good efficacy and safety in the treatment of oral cavity phlogosis due to oral or periodontal surgery.