Metronidazole Modified-Release Therapy Using Two Different Polymeric Systems Gels or Films: Clinical Study for the Treatment of Periodontitis
Abstract
:1. Introduction
2. Materials and Methods
2.1. Materials
2.2. Methods
2.2.1. Clinical Trial Characteristics
2.2.2. Preparation of Film System Containing Metronidazole and Metronidazole Benzoate
2.2.3. Preparation of a Semi-Solid (Gel) System Containing Metronidazole and Metronidazole Benzoate
2.2.4. Storage Conditions of Film and Gel Formulations
2.2.5. Introduction of the Polymeric Devices Into the Periodontal Pockets
2.2.6. Quantification of Drug Present in the Gingival Crevicular Fluid
2.2.7. In Vivo Evaluation of Periodontal Intrapocket pH
2.2.8. Evaluation of Clinical Parameters Indicative of Periodontitis
2.2.9. Statistical Analysis
3. Results
3.1. Quantification of Drug in Gingival Fluid
3.2. Evaluation of Periodontal Intrapocket pH and Clinical Parameters
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Component | Concentration (%) |
---|---|
Zein | 6.00 |
Plasticizer | 1.20 |
Metronidazole | 0.37 |
Metronidazole Benzoate | 0.75 |
Hydroethanolic solution (1:9) | 91.7 |
Component | Concentration (%) |
---|---|
Myverol® 18-92k | 56.57 |
Lipophilic surfactant SPAN 60 (sorbitan monostearate) HLB = 4.7 | 2.33 |
Metronidazole | 5.00 |
Metronidazole Benzoate | 16.10 |
Water | 20.00 |
Formulation | Mean Concentration (µg/mL) ± SD | Median (Range) |
---|---|---|
Film | 49.03 ± 69.87 | 21.84 (3.95; 244.69) |
Gel | 21.77 ± 17.49 | 14.64 (5.75; 57.43) |
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Bastos, M.D.R.; Dotta, T.C.; Kubata, B.R.; Nascimento, C.d.; Macedo, A.P.; Figueiredo, F.A.T.d.; Rocha, M.M.; Peixoto, M.P.G.; Ferreira, M.P.; Freitas, O.d.; et al. Metronidazole Modified-Release Therapy Using Two Different Polymeric Systems Gels or Films: Clinical Study for the Treatment of Periodontitis. Pharmaceutics 2024, 16, 1108. https://doi.org/10.3390/pharmaceutics16091108
Bastos MDR, Dotta TC, Kubata BR, Nascimento Cd, Macedo AP, Figueiredo FATd, Rocha MM, Peixoto MPG, Ferreira MP, Freitas Od, et al. Metronidazole Modified-Release Therapy Using Two Different Polymeric Systems Gels or Films: Clinical Study for the Treatment of Periodontitis. Pharmaceutics. 2024; 16(9):1108. https://doi.org/10.3390/pharmaceutics16091108
Chicago/Turabian StyleBastos, Mônica Danielle Ribeiro, Tatiane Cristina Dotta, Beatriz Roque Kubata, Cássio do Nascimento, Ana Paula Macedo, Fellipe Augusto Tocchini de Figueiredo, Millena Mangueira Rocha, Maria Paula Garofo Peixoto, Maíra Peres Ferreira, Osvaldo de Freitas, and et al. 2024. "Metronidazole Modified-Release Therapy Using Two Different Polymeric Systems Gels or Films: Clinical Study for the Treatment of Periodontitis" Pharmaceutics 16, no. 9: 1108. https://doi.org/10.3390/pharmaceutics16091108