Delan, W. K., I. H. Ali, M. Zakaria, B. Elsaadany, A. R. Fares, A. N. ElMeshad, and W. Mamdouh, "Investigating the bone regeneration activity of PVA nanofibers scaffolds loaded with simvastatin/chitosan nanoparticles in an induced bone defect rabbit model.", International journal of biological macromolecules, vol. 222, issue Pt B, pp. 2399-2413, 2022. Abstract

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.

Elsaadany, B., S. M. Anayb, K. Mashhour, M. Yossif, and F. 'heya Zahran, "Rebamipide gargle and benzydamine gargle in prevention and management of chemo-radiotherapy and radiotherapy-induced oral mucositis in head and neck cancer patients (randomized clinical trial).", BMC oral health, vol. 24, issue 1, pp. 645, 2024. Abstract

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.

Abbas, Y., B. Elsaadany, and N. Ghallab, "Prevalence of different stages of periodontal diseases among a sample of young adult obese Egyptian patients: a hospital based Cross-sectional study over 1 year.", BMC oral health, vol. 23, issue 1, pp. 573, 2023. Abstract

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.

Ahmed, E. M., S. Shafik, and B. Elsaadany, "Platelet-rich fibrin a new approach in management of persistent oral ulcers in blistering skin diseases.", Wound repair and regeneration : official publication of the Wound Healing Society [and] the European Tissue Repair Society, vol. 30, issue 4, pp. 491-497, 2022. Abstract

The present study designed to evaluate the healing power of platelet-rich fibrin (PRF) in terms of pain control and mucosal repair. A randomised, controlled, pilot clinical trial was conducted on 16 patients randomly distributed with 1:1 allocation ratio into two groups. The treatment group received PRF minced and mixed with orabase and the control group received clobetasol propionate 0.05% mixed with orabase. Pain reduction was evaluated as primary outcome along with mucositis healing as secondary outcome. A statistically significant difference in pain reduction was observed between the two groups (p ≤ 0.05). The clinical results at Day 7 has shown that PRF group had 100% pain reduction while, CP group had 32.5% reduction from base line. PRF offered superior clinical results providing rapid pain alleviation and accelerated ulcer healing compared to corticosteroids.

Delan, W. K., M. Zakaria, B. Elsaadany, A. N. ElMeshad, W. Mamdouh, and A. R. Fares, "Formulation of simvastatin chitosan nanoparticles for controlled delivery in bone regeneration: Optimization using Box-Behnken design, stability and in vivo study.", International journal of pharmaceutics, vol. 577, pp. 119038, 2020. Abstract

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.

Delan, W. K., M. Zakaria, B. Elsaadany, A. N. ElMeshad, W. Mamdouh, and A. R. Fares, "Formulation of simvastatin chitosan nanoparticles for controlled delivery in bone regeneration: Optimization using Box-Behnken design, stability and in vivo study.", International journal of pharmaceutics, vol. 577, pp. 119038, 2020. Abstract

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.

Shalaby, R. H., Y. Fathi, and B. Elsaadany, "Efficacy and safety of beta carotones in treatment of oral leukoplakia: systematic review and meta-analysis", Journal of oral research, vol. 8, issue (6), pp. 488-498, 2019.
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Elsaadany, B. A., M. Zakaria, and M. Mousa, "Transplantation of Bone Marrow-Derived Mesenchymal Stem Cells Preserve the Salivary Glands Structure after Head and Neck Radiation in Rats", open access macedonian journal of medical sciences, vol. 7, issue 10, pp. 1588-92, 2019.
Elsaadany, B., S. El Kholy, D. El Rouby, L. Rashed, and T. Shouman, "Effect of Transplantation of Bone Marrow Derived Mesenchymal Stem Cells and Platelets Rich Plasma on Experimental Model of Radiation Induced Oral Mucosal Injury in Albino Rats.", International journal of dentistry, vol. 2017, pp. 8634540, 2017. Abstract

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. . 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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