Danielle Ferreira Sobral-Souza1, Thayla Hellen Nunes Gouveia1, André Luís Condeles2, José Carlos Toledo Junior2, Bruno Vilela Muniz3, Michelle Franz-Montan3, Maria Cibelle Pauli4, Gislaine Ricci Leonardi5, Débora Alves Nunes Leite Lima6. 1. Department of Restorative Dentistry, Operative Dentistry Division, Piracicaba Dental School, University of Campinas - UNICAMP, P.O. BOX 52, Piracicaba, SP, 13414-903, Brazil. 2. Department of Chemistry, University of São Paulo - USP, Ribeirão Preto, SP, 140040-900, Brazil. 3. Department of Biosciences, Piracicaba Dental School, University of Campinas - UNICAMP, Piracicaba, SP, 13414-903, Brazil. 4. Department Translational Medicine, Federal University of São Paulo - UNIFESP, São Paulo, SP, Brazil. 5. Faculty of Pharmaceutical Sciences, University of Campinas - UNICAMP, Campinas, SP, Brazil. 6. Department of Restorative Dentistry, Operative Dentistry Division, Piracicaba Dental School, University of Campinas - UNICAMP, P.O. BOX 52, Piracicaba, SP, 13414-903, Brazil. dalima@unicamp.br.
Abstract
OBJECTIVE: To evaluate the physical-chemical (weight, pH, quantification of hydrogen peroxide) and mechanical (texture profile and rheology tests) properties of the experimental bleaching gel based on the bioadhesive polymer Aristoflex® AVC, after accelerated stability testing. MATERIALS AND METHODS: A total of 300 syringes of bleaching gels were divided into 5 groups (n = 60): Whiteness Perfect® 10%-FGM (WP); carbamide peroxide 10% with aristoflex (CPa); carbamide peroxide 10% with Carbopol (CPc); aristoflex thickener (A); and Carbopol thickener (C). According to the following requirements and time, the accelerated stability test was performed: in an incubator at 40 °C and 75% humidity per 1, 3, and 6 months, and baseline (refrigerator at 5 °C and 25% humidity). The variables were analyzed following the statistical tests: Two-way ANOVA and Tukey's test were applied to pH; weight data were analyzed using a mixed model for repeated measurements over time and the Tukey-Kramer test; one-way ANOVA and Tukey's test analyzed the rheology test; generalized linear models were used to quantify the peroxide amount and texture profile data. A significance level of 5% was considered. RESULTS: The experimental bleaches CPa and CPc had the highest pH values when compared to the others in 6 months. Thickeners A and C did not change the pH, weight, and active content over the accelerated stability times (p > 0.05). Furthermore, there was weight loss after 3 months of storage for CPa and CPc (p < 0.05). In the quantification of hydrogen peroxide, the WP group showed the highest values over time (p < 0.0001), only showing a significant loss after the 3rd month. Meanwhile, CPa and CPc showed a reduction in quantification from the 1st month. CONCLUSIONS: Temperature and humidity directly influenced the active content and properties of bleaching gels. In addition, the presence of components regardless of thickeners, such as stabilizers, in the commercial gel allowed for greater stability over time. CLINICAL RELEVANCE: The development of experimental bleaching gels for clinical use requires careful testing. Therefore, accelerated stability testing represents a valuable tool in the development and evaluation of cosmetic formulations.
OBJECTIVE: To evaluate the physical-chemical (weight, pH, quantification of hydrogen peroxide) and mechanical (texture profile and rheology tests) properties of the experimental bleaching gel based on the bioadhesive polymer Aristoflex® AVC, after accelerated stability testing. MATERIALS AND METHODS: A total of 300 syringes of bleaching gels were divided into 5 groups (n = 60): Whiteness Perfect® 10%-FGM (WP); carbamide peroxide 10% with aristoflex (CPa); carbamide peroxide 10% with Carbopol (CPc); aristoflex thickener (A); and Carbopol thickener (C). According to the following requirements and time, the accelerated stability test was performed: in an incubator at 40 °C and 75% humidity per 1, 3, and 6 months, and baseline (refrigerator at 5 °C and 25% humidity). The variables were analyzed following the statistical tests: Two-way ANOVA and Tukey's test were applied to pH; weight data were analyzed using a mixed model for repeated measurements over time and the Tukey-Kramer test; one-way ANOVA and Tukey's test analyzed the rheology test; generalized linear models were used to quantify the peroxide amount and texture profile data. A significance level of 5% was considered. RESULTS: The experimental bleaches CPa and CPc had the highest pH values when compared to the others in 6 months. Thickeners A and C did not change the pH, weight, and active content over the accelerated stability times (p > 0.05). Furthermore, there was weight loss after 3 months of storage for CPa and CPc (p < 0.05). In the quantification of hydrogen peroxide, the WP group showed the highest values over time (p < 0.0001), only showing a significant loss after the 3rd month. Meanwhile, CPa and CPc showed a reduction in quantification from the 1st month. CONCLUSIONS: Temperature and humidity directly influenced the active content and properties of bleaching gels. In addition, the presence of components regardless of thickeners, such as stabilizers, in the commercial gel allowed for greater stability over time. CLINICAL RELEVANCE: The development of experimental bleaching gels for clinical use requires careful testing. Therefore, accelerated stability testing represents a valuable tool in the development and evaluation of cosmetic formulations.