Danielle da Nóbrega Alves1, Ana Karoline Vieira Melo2, Adriano Francisco Alves3, Maria Rejane Cruz de Araújo2, Rubens da Silva Araújo4, Ricardo Dias de Castro5. 1. Department of Clinical and Social Dentistry, Graduate Program in Natural and Synthetic Bioactive Products (PgPNSB), Health Sciences Center, Federal University of Paraiba, João Pessoa, PB, Brazil. 2. Department of Clinical and Social Dentistry, Federal University of Paraiba, João Pessoa, Brazil. 3. Department of Physiology and Pathology, Health Sciences Center, Federal University of Paraiba, João Pessoa, PB, Brazil. 4. Health Sciences Center, Federal University of Paraiba, João Pessoa, PB, Brazil. 5. Department of Clinic and Social Dentistry, Health Sciences Center, Federal University of Paraiba, Campus I, João Pessoa, PB, 58051-970, Brazil. rcastro@ccs.ufpb.br.
Abstract
OBJECTIVE: To advance studies on the effect of a new pharmaceutical formulation for the treatment of oral fungal infections, we evaluated the safety and tolerability of orabase ointment containing cinnamaldehyde for use on the oral mucosa. MATERIAL AND METHODS: A clinical trial (phase I) was carried out on 35 individuals with healthy oral mucosa divided into three groups: ointments at 200 µg/mL, n = 12; 300 µg/mL, n = 11; and 400 µg/mL, n = 12. Product safety was assessed using three parameters: (a) clinical evolution as recorded by trained examiners; (b) evolution of the inflammatory process as registered by an exfoliative cytology exam and analyzed by trained pathologists; (c) mucosal swab to count Candida spp. colony-forming units (CFU). These parameters were analyzed both beforehand and at 15 days of treatment. RESULTS: The three ointment concentrations evaluated did not trigger inflammatory processes. The mycological analyses revealed a reduction of at least 99% in the number of Candida spp. CFU. In the exfoliative cytology analyses, the cells were found to be healthy. Participants reported a pleasant taste, yet 17% reported a slight burning sensation when applying the product. CONCLUSIONS: The ointment is safe and tolerable for use on healthy oral mucosa. TRIAL REGISTRATION: Registration number: RBR-7zwzs3. CLINICAL RELEVANCE: The ointment proved to be safe and tolerable for use on oral mucosa, encouraging studies to evaluate its clinical efficacy in patients with oral candidiasis, and contributing to a new therapeutic proposal for the treatment of fungal infections caused by Candida spp.
OBJECTIVE: To advance studies on the effect of a new pharmaceutical formulation for the treatment of oral fungal infections, we evaluated the safety and tolerability of orabase ointment containing cinnamaldehyde for use on the oral mucosa. MATERIAL AND METHODS: A clinical trial (phase I) was carried out on 35 individuals with healthy oral mucosa divided into three groups: ointments at 200 µg/mL, n = 12; 300 µg/mL, n = 11; and 400 µg/mL, n = 12. Product safety was assessed using three parameters: (a) clinical evolution as recorded by trained examiners; (b) evolution of the inflammatory process as registered by an exfoliative cytology exam and analyzed by trained pathologists; (c) mucosal swab to count Candida spp. colony-forming units (CFU). These parameters were analyzed both beforehand and at 15 days of treatment. RESULTS: The three ointment concentrations evaluated did not trigger inflammatory processes. The mycological analyses revealed a reduction of at least 99% in the number of Candida spp. CFU. In the exfoliative cytology analyses, the cells were found to be healthy. Participants reported a pleasant taste, yet 17% reported a slight burning sensation when applying the product. CONCLUSIONS: The ointment is safe and tolerable for use on healthy oral mucosa. TRIAL REGISTRATION: Registration number: RBR-7zwzs3. CLINICAL RELEVANCE: The ointment proved to be safe and tolerable for use on oral mucosa, encouraging studies to evaluate its clinical efficacy in patients with oral candidiasis, and contributing to a new therapeutic proposal for the treatment of fungal infections caused by Candida spp.
Authors: Saad F Alrayyes; Hammad M Alruwaili; Ibrahim A Taher; Khaled M Elrahawy; Abdulrahman H Almaeen; Awad O Ashekhi; Mohammad Khursheed Alam Journal: BMC Oral Health Date: 2019-05-22 Impact factor: 2.757