OBJECTIVE: To determine the effects of decoction derived from the leaves of Nicotiana tabacum (L.) as a mouthwash on minor recurrent aphthous. METHODS: A randomized double-blinded placebo-controlled clinical trial was conducted on 60 patients with minor recurrent aphthous. Treatment comprised of application of tobacco or placebo mouthwash (10 mL 3 times a day) for 5 days. Clinical evaluation included pain level using a visual analog scale and ulcer size on days 1, 3, and 5 were measured. Adverse effects after mouthwash application were recorded, and the oral mucosa was examined by the investigator at each visit. RESULTS: A total of 54 subjects with the mean age (38 ± 10) years fulfilled the study. No minor and major adverse effects were observed. In the treatment group, ulcer pain score was decreased by 79.2% and 93.8% and ulcer size was reduced by 69.1% and 92.2% (days 3 and 5, respectively), which was significantly greater than the control group (P < 0.01). CONCLUSION: The decoction prepared with of Nicotiana tabacum leaves, used as mouthwash are well-tolerated and safe, and can be used for the management of recurrent aphthous.
RCT Entities:
OBJECTIVE: To determine the effects of decoction derived from the leaves of Nicotiana tabacum (L.) as a mouthwash on minor recurrent aphthous. METHODS: A randomized double-blinded placebo-controlled clinical trial was conducted on 60 patients with minor recurrent aphthous. Treatment comprised of application of tobacco or placebo mouthwash (10 mL 3 times a day) for 5 days. Clinical evaluation included pain level using a visual analog scale and ulcer size on days 1, 3, and 5 were measured. Adverse effects after mouthwash application were recorded, and the oral mucosa was examined by the investigator at each visit. RESULTS: A total of 54 subjects with the mean age (38 ± 10) years fulfilled the study. No minor and major adverse effects were observed. In the treatment group, ulcer pain score was decreased by 79.2% and 93.8% and ulcer size was reduced by 69.1% and 92.2% (days 3 and 5, respectively), which was significantly greater than the control group (P < 0.01). CONCLUSION: The decoction prepared with of Nicotiana tabacum leaves, used as mouthwash are well-tolerated and safe, and can be used for the management of recurrent aphthous.