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OBJECTIVES: This study aimed to evaluate the preventive and therapeutic effects of rebamipide gargle in comparison with benzydamine in head and neck cancer patients undergoing radiotherapy with or without chemotherapy. MATERIALS AND METHODS: Phase III randomized clinical trial was conducted from January 2021 till August 2022 on one hundred patients with head and neck cancer receiving high doses of radiotherapy. These patients were equally allocated into either rebamipide group or benzydamine group, The measured outcomes were the incidence of oral mucositis ≥ grade1, according to the WHO mucositis scale, in addition to the duration, and the onset of oral mucositis. RESULTS: There was no statistically significant difference between the two groups, regarding the incidence of a severe grade of oral mucositis (WHO grades 3), as well as the onset and duration of oral mucositis. Both gargles succeeded to prevent the development of WHO grade 4 oral mucositis. Side effects reported were mainly burning sensation in benzydamine group and nausea in rebamipide group. CONCLUSION: Rebamipide mouthwash was as beneficial as benzydamine mouthwash in minimizing the incidence of severe oral mucositis induced by treatment of head and neck cancer. However, rebamipide gargle proved to be superior to benzydamine in terms of reduction in the severity of the radiation-induced oral mucositis. TRIAL REGISTRATION: The trial was registered in the protocol Registration and Result system of Clinical Trials (Registration ID: NCT04685395)0.28-12-2020.
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Alanina , Bencidamina , Neoplasias de Cabeza y Cuello , Antisépticos Bucales , Quinolonas , Estomatitis , Humanos , Estomatitis/prevención & control , Estomatitis/etiología , Neoplasias de Cabeza y Cuello/radioterapia , Bencidamina/uso terapéutico , Masculino , Persona de Mediana Edad , Femenino , Quinolonas/uso terapéutico , Alanina/análogos & derivados , Alanina/uso terapéutico , Antisépticos Bucales/uso terapéutico , Quimioradioterapia/efectos adversos , Traumatismos por Radiación/prevención & control , Anciano , AdultoRESUMEN
BACKGROUND: This cross-sectional study aimed to determine the prevalence of different stages of periodontal diseases based on the recent classification in a sample of young adult obese Egyptian dental outpatients. METHODS: This study included 314 patients seeking dental treatment at the Diagnostic Center of the Dental hospital, Faculty of Dentistry, Cairo University. Validated oral health questionnaire for adults regarding their age, gender, level of education and oral health routines as well as oral health impact profile questionnaire for chronic periodontitis (OHIP-CP) were filled by all patients. Obesity parameters were also assessed through person's weight in kilograms, height in centimeters and waist circumference to determine the obesity stage. Diagnosis was made based on measurements of clinical periodontal parameters including a full mouth plaque index (PI), bleeding on probing (BoP), pocket depth (PD), clinical attachment level (CAL) and gingival recession depth (RD). Radiographic examination was performed using periapical radiographs. Ordinal logistic regression analysis was used to determine significant predictors of periodontal diseases and discriminant analysis was performed to predict periodontal disease classification. RESULTS: The age range in the study sample was 19-39 years old. The prevalence of different stages of periodontal diseases was 100%. Gingivitis was the most prevalent periodontal disease (63.7%) followed by Periodontitis Stage III (22.6%) then Stage II (11.1%). Stage I showed the least prevalence (2.5%). An increase in BMI was statistically associated with an increase in PD, CAL, RD, PI and vice versa (P-value < 0.05). The total OHIP-CP was 15.99 ± 3.06 for all participants. CONCLUSIONS: There was a statistically significant association between periodontal diseases and obesity in young adults, as well as a statistically significant direct correlation between BMI and periodontal parameters. Self-assessment of oral health and obesity were significant predictors of periodontal disease. CLINICAL TRIAL REGISTRATION ID: NCT04618068.
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Periodontitis Crónica , Enfermedades Periodontales , Adulto , Humanos , Adulto Joven , Estudios Transversales , Índice de Placa Dental , Egipto/epidemiología , Obesidad/complicaciones , Obesidad/epidemiología , Pérdida de la Inserción Periodontal/epidemiología , Enfermedades Periodontales/epidemiología , PrevalenciaRESUMEN
Patients with Sjögren's syndrome are at a higher risk to develop oral candidiasis than the general population. As antifungals have many side-effects, new approaches are needed to address this problem. This randomized controlled study aimed to evaluate the short-term efficacy of probiotics in the reduction of oral candidal growth in patients with SS. Thirty-two Sjogren's syndrome patients were randomly allocated in two groups receiving either Probiotics or placebo capsules twice a day for 5 weeks. The strains included in the probiotic capsule were Lactobacillus acidophilus, Lactobacillus bulgaricus, Streptococcus thermophilus and Bifidobacteriumbifidum. Oral rinse solution samples were collected and candidal levels were determined (CFU/mL) at baseline and after the 5-week experimental period. Pain, erythema and angular cheilitis were also assessed at baseline and after 2, 4 and 5-week. In the probiotic group, there was a statistically significant reduction of the candidal load from baseline to the 5th week respectively. However, the change in candidal load at the same time in the placebo group was not statistically significant. The tested probiotic product may represent an unconventional method to reduce candidal colonization, to prevent oral candidosis in patients with Sjogren's syndrome.Clinical trials registration ID NCT03840538 (https://clinicaltrials.gov/show/NCT03840538).
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Candidiasis Bucal , Probióticos , Síndrome de Sjögren , Humanos , Antifúngicos/efectos adversos , Candidiasis Bucal/prevención & control , Candidiasis Bucal/tratamiento farmacológico , Método Doble Ciego , Probióticos/uso terapéutico , Síndrome de Sjögren/complicaciones , Síndrome de Sjögren/tratamiento farmacológicoRESUMEN
This study aims at preparing electrospun PVA NFs incorporating simvastatin/chitosan nanoparticles (SIM CS NPs) as a controlled drug eluting scaffold for bone regeneration. Optimization was performed by Design Expert® software through establishing two factor, three level factorial design, where the independent variables were the applied voltage, flow rate and PVA solution/SIM CS NPs ratio. Formulation variables values for the optimized formula were 18KV, 0.5 mL/h, and 3:1 respectively. NFs diameter and mesh pore size were chosen as the dependent variables. The optimized NFs were evaluated morphologically, chemically, and physically. Additionally, in-vitro SIM release from the scaffolds was investigated along 24 days. Optimum NFs possessed 136 nm diameter size and 6.5 nm porosity. Also, they showed sustained SIM release for 24 days to achieve the desired goal in bone regeneration. The optimized NFs were implanted within induced bone defects in rabbits. In-vivo assessments were performed through cone beam computed tomography 3D images, bone density measurements, histological analysis and bone morphogenetic protein 2 (BMP 2) level. The obtained results proved the high potential of the optimized NFs in promoting bone regeneration compared to untreated group, non-medicated NFs group, free SIM group and NFs loaded with SIM group after 6 weeks of implantation.
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Quitosano , Nanofibras , Nanopartículas , Animales , Conejos , Simvastatina/farmacología , Regeneración Ósea , Andamios del TejidoRESUMEN
This study aims to formulate and optimize simvastatin loaded chitosan-tripolyphosphate nanoparticles (SIM CS-TPP NPs) using ionic gelation method to provide a local delivery system that controls and sustains the release of simvastatin in the desired dose to promote bone regeneration. Box-Behnken design was adopted for optimization of the formulation variables of the prepared nanoparticles namely, CS percentage, TPP percentage and homogenization time. The optimized formula was selected and characterized by transmission electronic microscopy, in-vitro release, swelling index and storage stability. The ability of the optimum formula to stimulate bone regeneration upon implantation in bone defect generated in rabbits was also evaluated. The optimum SIM CS-TPP NPs had particle size of 106 nm, zeta potential of 43.3 mv, polydispersity index of 0.295 and entrapment efficiency of 98.78% and also showed good storage stability over the first month in addition to controlled and steady release over 2 weeks that effectively delivered simvastatin in a therapeutic dose needed for bone regeneration. Cone beam computed tomography 3D images, bone density measurements and histopathological analysis confirmed the high potential of SIM CS-TPP NPs in promoting bone regeneration in the generated defects compared to both the non-medicated formula and untreated groups after 6 weeks of implantation.
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Regeneración Ósea/efectos de los fármacos , Quitosano/análogos & derivados , Composición de Medicamentos/métodos , Nanopartículas/química , Simvastatina/química , Administración Oral , Animales , Disponibilidad Biológica , Densidad Ósea/efectos de los fármacos , Quitosano/química , Tomografía Computarizada de Haz Cónico , Portadores de Fármacos/química , Portadores de Fármacos/farmacología , Liberación de Fármacos , Estabilidad de Medicamentos , Masculino , Microscopía Electrónica de Transmisión , Tamaño de la Partícula , Conejos , Simvastatina/farmacocinética , Simvastatina/farmacología , Propiedades de SuperficieRESUMEN
BACKGROUND: The salivary glands are one of the radiation sensitive tissues during radiotherapy in the treatment of head and neck cancer. Within the first weeks of radiotherapy, the radiation causes progressive loss of gland function, then continue throughout the later of the patient's life. AIM: The present work was designed to discover the potential effect of bone marrow-derived mesenchymal stem cells (MSCs) injected locally and in decreasing the unwanted effects of radiation on rats salivary gland. MATERIAL AND METHODS: 6 rats used as the control group (N) and 12 rats had a single radiation dose of 13Gy in the head and neck then, they were equally allocated into two groups: Irradiated only as a group (C), Irradiated then treated with MSCs as a group (S). The animals were euthanised 7 days post radiation. Then, submandibular salivary glands were cut up; the histological examination was done. RESULTS: Histological examination of the treated group(S) shown an apparent improvement in the SG structure and function compared to the irradiated group (C), this improvement represented mainly as preserving acini diameter (mean diameter in µm group (C) 183.1 ± 4.5, in group (S) 356.3 ± 33.5 while, in (N) group 408.9 ± 5.9) and decrease in fibrotic areas in the gland (mean fibrosis parentage in group (C) 26.5 ± 5.9 in (C) group , in group (S) 11.7 ± 4.13 while in (N) group 0.2 ± 0.31). CONCLUSION: BM-MSCs has revealed to be promising in mitigating the side effects of radiotherapy on salivary glands structure.
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BACKGROUND: Oral chronic graft versus host disease (cGVHD) is a major complication in transplantation community, a problem that can be addressed with topical intervention. Topical corticosteroids are the first line of treatment although the choice remains challenging as none of the available treatments is supported by strong clinical evidence. OBJECTIVE: This systematic review aims to determine the clinical efficacy and safety of topical corticosteroids for the management of the mucosal alterations of oral cGVHD. DATA SOURCES: Electronic search of different databases was conducted: PubMed, Cochrane library, Grey literature, WHO, and clinical trials.gov for clinical trial registration as well as hand search in the references of relevant articles up to November 2016. DATA EXTRACTION: Extracted pieces of information were intervention, population, sample sizes, and outcomes. DATA SYNTHESIS: Six studies were included: 2 randomized clinical trials (RCTs), 3 cohort studies, and 1 pre-post clinical trial. RESULTS: There is a limited evidence concerning clinical efficacy of topical corticosteroids. Clobetasol, dexamethasone, and budesonide were the topical corticosteroid of choice. The highest level of evidence score was given to clobetasol followed by budesonide with a lower evidence level. CONCLUSION: All three topical corticosteroid preparations are effective for management of oral chronic GVHD with minimal easily avoided side effects.
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Normal tissue damage following radiotherapy is still a major problem in cancer treatment. Therefore, the current work aimed at exploring the possible role of systemically injected bone marrow derived mesenchymal stem cells (BM-MSCs) and/or locally injected platelet rich plasma (PRP) in ameliorating the side effects of ionizing radiation on the rat's tongue. Twelve rats served as control group (N) and 48 rats received a single radiation dose of 13 Gy to the head and neck region; then, they were equally divided into 4 experimental groups: irradiated only (C), irradiated + MSCs (S), irradiated + (PRP) (P), and combined group (PS). Animal scarification occurred in 3 and 7 days after radiation. Then, tongues were dissected and examined histologically and for expression of bcl-2 by RT-PCR. Histological examination of the treated groups (S), (P), and (PS) revealed an obvious improvement in the histological structure of the tongue, compared to group (C), in addition to upregulated expression of bcl-2, indicating decreased apoptotic activity. Conclusion. BM-MSCs and PRP have shown positive effect in minimizing the epithelial atrophy of normal oral mucosa after regional radiotherapy, which was emphasized by decreasing apoptotic activity in these tissues. Nevertheless, combined use of BM-MSCs and PRP did not reveal the assumed synergetic effect in oral tissue protection.
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OBJECTIVES: For over a century, a heated debate existed over the possibility of malignant transformation of oral lichen planus (OLP). We performed this meta-analysis to evaluate the malignant potential of OLP and oral lichenoid lesions (OLL) and investigate the possible risk factors for OLP malignant transformation into oral squamous cell carcinoma (OSCC). MATERIALS AND METHODS: We searched Medline, Scopus, and Web of Knowledge for relevant observational studies. Data on OLP malignant transformation were calculated as a pooled proportion (PP), using the Der-Simonian Liard method. We performed subgroup analyses by OLP diagnostic criteria, site, and clinical type, using Open Meta[Analyst] software. Data on possible risk factors for malignant transformation were pooled as odds ratios (ORs), using Comprehensive Meta-Analysis software. RESULTS: Pooling data for OLP malignant transformation from 57 studies (19,676 patients) resulted in an overall PP of 1.1% [95% CI: 0.9%, 1.4%], while pooling data from 14 recent studies that used the World Health Organization-2003 diagnostic criteria resulted in an overall-PP of 0.9% [95% CI: 0.5%, 1.3%]. The risk of malignant transformation was higher (PP=2.5%, 95% CI [1%, 4%]) in OLL patients (419 patients). A significant increase of malignant transformation risk was noted among smokers (OR=2, 95% CI [1.25, 3.22]), alcoholics (OR=3.52, 95% CI [1.54, 8.03]), and HCV-infected patients (OR=5, 95% CI [1.56, 16.07]), compared to patients without these risk factors. CONCLUSION: A small subset of OLP patients (1.1%) develop OSCC; therefore, regular follow-up for these patients is recommended. A higher incidence of malignant transformation was found among smokers, alcoholics, and HCV-infected patients; however, these associations should be further investigated.
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Carcinoma de Células Escamosas/patología , Transformación Celular Neoplásica , Liquen Plano Oral/patología , Neoplasias de la Boca/patología , Anciano , Femenino , Humanos , Masculino , Persona de Mediana EdadRESUMEN
Objectives: A systematic review was conducted to evaluate effectiveness and safety of beta carotenes for the treatment of oral leukoplakia regarding clinical resolution and prevention of malignant transformation. Material and Methods: The systematic search was conducted in three electronic databases and the study's selection was performed according to pre-set eligibility criteria. Four studies evaluating the efficacy of beta carotenes in oral leukoplakia compared to placebo were included in the review; three of which were assigned for quantitative analysis. Data were extracted, tabulated, quality assessed and statistically analyzed. Results: The meta-analysis revealed that when comparing clinical resolution the beta carotene group favored was favored compared to placebo, with statistically significant difference. However, a meta-analysis comparing beta carotene and placebo groups regarding malignant transformation as a primary outcome failed to show any significant benefit. Furthermore, results showed evidence of beta carotene safety. Conclusion: the overall quality of evidence about efficacy of beta carotene in oral leukoplakia treatment was not high. However, given the obvious safety of this agent, data suggests it could have a promising effect in clinical improvement of oral leukoplakia lesions. However, no evidence supporting its benefits in reducing risk of malignant transformation in these lesions was found. Therefore, further long term, well designed randomized clinical trials are highly recommended.
Objetivos: Se realizó una revisión sistemática para evaluar la efectividad y la seguridad de los betacarotenos para el tratamiento de la leucoplasia oral en relación con la resolución clínica y la prevención de la transformación maligna. Material y Métodos: la búsqueda sistemática se realizó en tres bases de datos electrónicas y la selección del estudio se realizó de acuerdo con los criterios de elegibilidad preestablecidos. En la revisión se incluyeron cuatro estudios que evaluaban la eficacia de los betacarotenos en la leucoplasia oral en comparación con el placebo; tres de los cuales fueron asignados para el análisis cuantitativo. Los datos fueron extraídos, tabulados, su calidad evaluada y analizados estadísticamente. Resultados: El metanálisis reveló que al comparar la resolución clínica, el grupo de betacaroteno fue favorecido en comparación con el placebo, con una diferencia estadísticamente significativa. Sin embargo, un metaanálisis que comparó los grupos de betacaroteno y placebo con respecto a la transformación maligna como resultado primario no mostró ningún beneficio significativo. Además, los resultados mostraron evidencia de seguridad de betacaroteno. Conclusión: La calidad general de la evidencia sobre la eficacia del betacaroteno en el tratamiento de la leucoplasia oral no es alta. Sin embargo, dada la obvia seguridad de este agente, los datos sugieren que podría tener un efecto prometedor en la mejora clínica de las lesiones de leucoplasia oral. Sin embargo, no se encontraron pruebas que respalden sus beneficios en la reducción del riesgo de transformación maligna en estas lesiones. Por lo tanto, se recomiendan ensayos clínicos aleatorios bien diseñados a largo plazo.