BACKGROUND: The systemic use of non-steroidal anti-inflammatory drugs are associated with various side-effects like hepatotoxicity, blood dyscrasias, nephrotoxicity and gastric irritability. Among these, gastric irritability is the most common and the most important one, which should be taken care of. Therefore, it may be preferable to use a local formulation such as a mouthwash to treat the inflammatory conditions of the oral cavity. AIM: To determine the efficacy and acceptability of 0.074% diclofenac mouthwash in relieving pain and inflammationof post-periodontal surgery patients. MATERIALS AND METHODS: The study was designed as a double-blind, placebo-controlled clinical trial. Twenty chronic periodontitis patients who were scheduled for full-mouth periodontal flap surgery were randomized to receive either diclofenac mouthwash or placebo to rinse with 15 ml of solution daily for a period of 7 days. Modified gingival index (Lobene 1986) was used to verify gingival inflammation and visual analog scale was used to assess pain. After the baseline measurements for all the parameters were recorded, spontaneous pain and burning were evaluated daily while redness and edema were recorded on the 3 rd and 7 th day from the day of treatment. RESULTS: Data obtained were analyzed statistically using paired " t" test for intragroup comparison and unpaired " t"-test for intergroup comparison. Spontaneous pain was significantly reduced by diclofenac mouthwash. Other parameters, i.e. gingival inflammation and swelling, had not shown significant reduction in scores in either group, although the reduction was higher in the test group. CONCLUSION: The new 0.074% diclofenac mouthwash is an effective and tolerable medicinal product for post-surgical symptomatic relief.
RCT Entities:
BACKGROUND: The systemic use of non-steroidal anti-inflammatory drugs are associated with various side-effects like hepatotoxicity, blood dyscrasias, nephrotoxicity and gastric irritability. Among these, gastric irritability is the most common and the most important one, which should be taken care of. Therefore, it may be preferable to use a local formulation such as a mouthwash to treat the inflammatory conditions of the oral cavity. AIM: To determine the efficacy and acceptability of 0.074% diclofenac mouthwash in relieving pain and inflammation of post-periodontal surgery patients. MATERIALS AND METHODS: The study was designed as a double-blind, placebo-controlled clinical trial. Twenty chronic periodontitispatients who were scheduled for full-mouth periodontal flap surgery were randomized to receive either diclofenac mouthwash or placebo to rinse with 15 ml of solution daily for a period of 7 days. Modified gingival index (Lobene 1986) was used to verify gingival inflammation and visual analog scale was used to assess pain. After the baseline measurements for all the parameters were recorded, spontaneous pain and burning were evaluated daily while redness and edema were recorded on the 3 rd and 7 th day from the day of treatment. RESULTS: Data obtained were analyzed statistically using paired " t" test for intragroup comparison and unpaired " t"-test for intergroup comparison. Spontaneous pain was significantly reduced by diclofenac mouthwash. Other parameters, i.e. gingival inflammation and swelling, had not shown significant reduction in scores in either group, although the reduction was higher in the test group. CONCLUSION: The new 0.074% diclofenac mouthwash is an effective and tolerable medicinal product for post-surgical symptomatic relief.