Mian Waqar Mustafa1, Suwipa Ungphaiboon2, Narubodee Phadoongsombut3, Kanokporn Pangsomboon4, Sureerat Chelae5, Sirima Mahattanadul1,6. 1. 1 Department of Clinical Pharmacy, Faculty of Pharmaceutical Sciences, Prince of Songkla University, Hat Yai, Thailand. 2. 2 Department of Pharmaceutical Technology, and Faculty of Pharmaceutical Sciences, Prince of Songkla University, Hat Yai, Thailand. 3. 3 Department of Pharmaceutical Chemistry, Faculty of Pharmaceutical Sciences, Prince of Songkla University, Hat Yai, Thailand. 4. 4 Department of Stomatology, Faculty of Dentistry, Prince of Songkla University, Hat Yai, Thailand. 5. 5 Division of Clinical Microbiology, Department of Pathology, Faculty of Medicine, Prince of Songkla University, Hat Yai, Thailand. 6. 6 Phytomedicine and Pharmaceutical Biotechnology Excellence Center, Faculty of Pharmaceutical Sciences, Prince of Songkla University, Hat Yai, Thailand.
Abstract
Objective: An alcohol-free mouthwash of curcuminoids purified from the turmeric (Curcuma longa Linn.) rhizome was formulated using a cosolvent system, comprising chitosan and polyethylene glycol (PEG) 400, and determined for its efficacy and safety in management of denture stomatitis (DS) in comparison with a chlorhexidine (CHX) mouthwash. Design: A single-center, randomized, controlled parallel-arm trial was conducted. Setting: The study took place at the Faculty of Dentistry, Prince of Songkla University, Hat-Yai, Thailand, between June 2016 and June 2017. Subjects: Participants were 20 years old or older adults of both genders, using removable dentures, and with a confirmed diagnosis of DS from an oral medicine specialist. Interventions: A total of 30 patients were randomly assigned to 3 different interventions, including the chitosan-curcuminoid (CHI-CUR) mouthwash, CHX mouthwash, and a vehicle formulation comprising chitosan and PEG 400. Ten milliliters of each intervention was given to the patient to be used for 30 sec, three times a day at 8 am, 12 pm, and 4 pm, for 2 weeks. Outcome measures: Outcome measures included complete relief of erythematous lesions under the denture and reduction in the number of candida colonies present in the denture-fitting surface. Results: Eight of 10 patients (80%) using the CHI-CUR mouthwash had a complete response after the 2-week treatment course compared with 30% of patients using the CHX mouthwash (p < 0.05). Both interventions exerted comparable anticandida efficacy. No oral or systemic adverse events that could possibly be related to the use of mouthwash were documented. Conclusions: The finding indicated that an alcohol-free CHI-CUR mouthwash may serve as a safe and potential topical therapeutic alternative in treating generalized or candida-associated DS.
RCT Entities:
Objective: An alcohol-free mouthwash of curcuminoids purified from the turmeric (Curcuma longa Linn.) rhizome was formulated using a cosolvent system, comprising chitosan and polyethylene glycol (PEG) 400, and determined for its efficacy and safety in management of denture stomatitis (DS) in comparison with a chlorhexidine (CHX) mouthwash. Design: A single-center, randomized, controlled parallel-arm trial was conducted. Setting: The study took place at the Faculty of Dentistry, Prince of Songkla University, Hat-Yai, Thailand, between June 2016 and June 2017. Subjects: Participants were 20 years old or older adults of both genders, using removable dentures, and with a confirmed diagnosis of DS from an oral medicine specialist. Interventions: A total of 30 patients were randomly assigned to 3 different interventions, including the chitosan-curcuminoid (CHI-CUR) mouthwash, CHX mouthwash, and a vehicle formulation comprising chitosan and PEG 400. Ten milliliters of each intervention was given to the patient to be used for 30 sec, three times a day at 8 am, 12 pm, and 4 pm, for 2 weeks. Outcome measures: Outcome measures included complete relief of erythematous lesions under the denture and reduction in the number of candida colonies present in the denture-fitting surface. Results: Eight of 10 patients (80%) using the CHI-CUR mouthwash had a complete response after the 2-week treatment course compared with 30% of patients using the CHX mouthwash (p < 0.05). Both interventions exerted comparable anticandida efficacy. No oral or systemic adverse events that could possibly be related to the use of mouthwash were documented. Conclusions: The finding indicated that an alcohol-free CHI-CUR mouthwash may serve as a safe and potential topical therapeutic alternative in treating generalized or candida-associated DS.