2^nd International Conference on Clinical Trials August 22-24, 2016 Philadelphia, Pennsylvania, USA

Biography:

Marina M J Romero-Prado has completed his PhD from Autonomous University of Madrid (UAM), Spain. She is a Molecular Biologist, Geneticist and works as a Professor and Director of a research team focused on pharmacogenetics of complex metabolic diseases at the Experimental and Clinical Therapeutics Institute in CUCS, University of Guadalajara. She has published her discoveries in expression regulation of growth hormone gene and molecular and cellular research about biological potential of mesenchymal stem cells. Her incursion as leader in clinical protocols has served to bind the basic and applied research in complementary medicine. 

Abstract:

Introduction: Previously we have shown that dietary flavonoids (DF) administrated to antihypertensive pharmacological therapy (AHT) have additional benefits on blood pressure, lipid profile, inflammation and obesity in hypertensive young people. In the present work, we compared the efficacy of this approach with DF on electrocardiography parameters on both gender patients from 20 to 50 years.

Material & Methods: 37 male and 42 female patients with hypertension grade I (n=27) or II (n=52) received 425.8±13.9 mg gallic acid equivalents (GAE) from dietary flavonoids were added to AHT based on captopril (50 mg/day) or telmisartan (40 mg/day) during 6 months. The standard electrocardiogram (ECG) 12-lead was recorded at 25 mm/s and 1 mV/cm measured at 0, 3 and 6 months of treatment. The ECGs criteria was: The Cornell voltage combination (CV)=(RaVL+SV3); the Cornell product (CP), considered as the product of QRS duration times the CV. The media changes between base line to the end of the study were considered as significant at P<0.05.

Results: By gender, the SBP diminution was significantly lower in women with AHT+DF vs. AHT (−40.5±8.4 vs. −30.65±9.2 mm Hg) (P=0.002). DBP reduction was different in women with ATH (−18.3±8.4 mm Hg) vs. ATH+DF (−20.6±5.1 mm Hg) (P=0.049); while men with AHT showed (−17.9±4.6) vs. ATH+DF (−21±5) (P=0.03).

Conclusion: By gender, male were the most favored than women in the CP diminution, so the response to DF added to AHT in BP and ECG parameters depends on patient’s gender.

Biography:

Joe Martinez serves as the CEO of Center Point Clinical Services. He brings over 30 years of successful leadership experience in the pharmaceutical, biotech and Medicaid industries. He instituted novel industry programs utilizing RWE (real world evidence) and health outcomes information to communicate product value information to health care decision-makers. His research abstracts and poster presentations have been accepted by national and international associations including ADA, ASCP, AMCP, AGS, AADE and AACE.

Abstract:

Currently, ‘patient-centricity’ has gathered visibility and momentum in the media, in the clinical industry and with regulatory authorities as a way to improve trial enrollment, patient retention and study outcomes. Many clinical trials must plan to over-enroll because according to a Tufts Study, 37% of sites under enroll, while 11% do not enroll even one patient. Patient-centricity has become known as “Direct-to-Patient” (DtP) when being discussed as part of a clinical trial protocol. While DtP places the patient at the center of the research process, it engages the patient more directly and can also address geographical challenges in trial operations and logistics. Important items to consider when successfully incorporating DtP into your next clinical trial include: Regulatory Considerations – Policies and acceptable processes vary by country and it’s advisable to begin a dialogue with the appropriate regulatory authority early in the trial planning process. Good Clinical Practices – Clear investigation plan to address the specifics of DtP, and considering a hybrid approach with an option to ‘opt out’. Privacy Laws – Understanding and appropriate guidance to comply with local and global data protection laws. Good Distribution Practices – Well-documented supply chain and processes to ensure chain of custody. Future trials will include a DtP component to address ongoing challenges of patient enrollment, retention, compliance and outcomes. In addition, a decreased number of study sites may provide added benefits of decreased trial costs, increased operational efficiency and enhanced data collection.

Biography:

Songul Cetik is an Assistant Professor at Vocational Higher of Health Services, Mardin Artuklu University in Turkey. She has completed her graduation from Eskisehir Osmangazi University, Faculty of Arts and Sciences, Department of Biology, 2009. She has done her Post-graduation from Eskisehir Osmangazi University, Faculty of Science, 2014. 

Abstract:

Cardiotoxicity is one of the limiting side effects of this commonly used anticancer agent and cardio toxic effects of cyclophosphamide (CP) were found to be dose-related cardiac damage, morphologically defined as necrosis and bleeding. Hypericum triquetrifolium Turra (HT) has a phenolic component with anti-oxidative and anticarciogenic properties. This study aimed to investigate the possible protective effect of HT on CP-induced cardiotoxicity. Serum aspartate transaminase (AST), alanine transaminase (ALT), lactate dehydrogenase (LDH), malondialdehyde (MDA), creatine kinase-MB (CK-MB), total oxidant state (TOS), total antioxidant state (TAS) and oxidative stress index (OSI) were examined. Furthermore, the cardiac tissues were analyzed histologically. Albino rats (Wistar, 3-4 months old, male, weight 220±20 g healthy) were randomly divided into 9 groups, each including 7 animals: Group 1 (control) treated with 0.5 ml saline; Group 2 treated with 150 mg/kg CP; GroupS 3, 4 and 5 treated with 25, 50 and 100 mg/kg HT respectively; Groups 6, 7 and 8 treated with 25, 50 or 100 mg/kg HT+CP respectively; and Group 9 treated with 0.5 ml-0.2% DMSO. The results were analyzed by one way analysis of variance and Kruskal-Wallis one way analysis of variance on ranks test. Levels of AST, ALT, LDH, MDA, CK-MB, TOS and OSI were found high only in the CP groups. GSH and TAS levels were found low in the only CP groups. It was also observed that CP-induced cardiotoxicity was dose dependent. Hemorrhage, inflammatory cell infiltration and the separation of the muscle fibers in the heart tissue supported the biochemical data. With 25, 50, 100 mg/kg HT, there was an significant decrease in the CP toxicity; reduced inflammation and lipid peroxidation in the heart tissue and increase of serum glutathione (GSH) and total antioxidant capacity (TAS) levels were found when HT was applied. Based on these findings, it can be proposed that HT was a strong candidate in preventing the CP-induced cardiotoxicity but further clinical studies need be done in order to verify its application on humans. 

Biography:

Nicola Stagg has completed her PhD in Pharmacology and Toxicology from University of Arizona. She is a DABT Toxicologist in Drug Development with more than 8 years experience as a Nonclinical Toxicologist designing GLP and non-GLP toxicology studies, interpreting data, conducting mechanistic studies, submitting regulatory documents and presenting to regulatory agencies globally. She serves as a Lead Toxicologist for several antibody drug conjugate and large molecule oncology programs at Genentech. She has worked on over 20 different drug development programs. She is the author of 11 peer-reviewed journal articles, 2 patents and over 15 published abstracts. 

Abstract:

Antibody drug conjugates (ADC) consist of potent cytotoxic drugs conjugated to antibodies via chemical linkers, which enables specific targeting of tumor cells while reducing systemic exposure to the cytotoxic drug to improve the therapeutic window of chemotherapy drugs. The valine citrulline monomethyl auristatin E (vcMMAE) ADC platform (conventional linker-drug conjugation) has shown promising clinical activity in a variety of cancers, but peripheral neuropathy (PN) has been observed in the clinic but not in nonclinical toxicology studies. We evaluated four possible hypotheses for the lack of translatability of PN in nonclinical toxicology studies with conventional vcMMAE ADCs: 1) exposure differences; 2) sensitivity of the animal model; 3) differences in how ADC properties manifest; and 4) susceptibility of clinical population. The result of this hypothesis-based approach identified several challenges with trying to model the PN observed in late stage oncology patients in our nonclinical toxicology studies with MTI containing ADCs due to a combination of factors related to all four hypotheses. However, it also enabled us to more systematically determine if a better in vivo animal model could be employed to improve translatability. While many data gaps still remain; increasing duration of exposure and incorporating an expanded neurohistopathology assessment of peripheral nerves in our nonclinical toxicology studies may enable us to reproduce the PN observed with conventional vcMMAE ADCs. The ultimate goal is to be able to have a model to screen the next generation MTI-ADCs for reduced incidence and severity of peripheral neuropathy. 

Biography:

Dr. Elena Landoni has completed his PhD at the age of 28 years from University of Milan and works as biostatistician at the Fondazione IRCCS Istituto Nazionale dei Tumori in Milan. Her research involves the application of machine learning methods for the analysis of high-dimensional ‘omics’ data. In particular, she is focused on the discovery and development of cancer molecular biomarkers, with implementation of feature selection algorithms together with the use of original and simple graphical representations of the results. Another area of her interests is nonparametric statistics, applied in particular to the fields of molecular biology and personalized medicine.

Abstract:

Background: Plasma miRNAs have the potential as cancer biomarkers but no consolidated guidelines for data mining in this field are available. The purpose of the study was to apply a supervised data analysis strategy in a context where prior knowledge is available, i.e. that of hemolysis-related miRNAs deregulation, so as to compare our results with existing evidence.

Results: We developed a structured strategy with innovative applications of existing bioinformatics methods for supervised analyses including: 1) the combination of two statistical (t- and Anderson-Darling) test results to detect miRNAs with significant fold change or general distributional differences in class comparison, which could reveal hidden differential biological processes worth to be considered for building predictive tools; and 2) a bootstrap selection procedure together with machine learning techniques in class prediction to guarantee the transferability of results and explore the interconnections among the selected miRNAs, which is important for highlighting their inherent biological dependences. The strategy was applied to develop a classifier for discriminating between hemolyzed and non hemolyzed plasma samples, defined according to a recently published hemolysis score. We identified five miRNAs with increased expression in hemolyzed plasma samples (miR-486-5p, miR-92a, miR-451, miR-16, and miR-22).

Conclusions: We identified four miRNAs previously reported in the literature as hemolysis related together with a new one (miR-22) which needs further investigations. Our findings confirm the validity of the proposed strategy and, in parallel, the hemolysis score capability to be used as pre-analytic hemolysis detector. R codes for implementing the approaches are provided.

Biography:

Abdoul Habib BEAVOGUI has completed his PhD at the in 2010 from Claude Bernard University in Lyon, France before returning to Guinea to set up a clinical research team at Maferinyah. He is the director of Maferinyah Training and Research Center in Rural Health, a public institution. He has participated to three clinical trials on Ebola in Guinea published more than 20 papers in reputed journals.

Abstract:

This study report on a portfolio of clinical research conducted in Guinea during the Ebola epidemic and draw the lessons learnt for the future from our perspective as Guinean medical researchers. We conducted a qualitative review of clinical research conducted in Guinea from June 2014 to July 2015, with a focus on vaccine and treatment studies. We also met with key stakeholders to discuss their views on the lessons learnt. Between June 2014 and July 2015, there was an increase in clinical research activities in Guinea. Three main types of clinical studies were undertaken during this period in Guinea: treatment studies (5 studies), vaccine studies (2 studies) rapid diagnosis test studies (9 studies) and natural history cohort studies (3 studies). Randomization was only possible in the WHO sponsored vaccine trial and with the JIKIMAPP trial (NIH/INSERM sponsored trial). The remaining trials (JIKI trial, Ebola_Tx trial and Interferon trial) used historical controls at their study sites for comparisons. Strong political will enabled a supportive environment for clinical research. Good complementarity between ethics and regulatory bodies reduced delays in the review processes for research consortia and communities (survivors for instance) were strongly involved in the research projects. The challenges included incorrect communication at the beginning of the outbreak, lack of proven treatment for Ebola, the debate about randomization, the high number of infections among health care workers, the lack of qualified human resources and sociocultural barriers and stigmatization against Ebola survivors along with governance issues.

Biography:

Abstract:

Subject recruitment and retention in clinical studies are identified as major barriers to finishing clinical studies in a timely manner. Soaring drug development costs mean that each day a drug is delayed from reaching the market, sponsors are losing as much as $8M per day. Sponsors must find ways to save time in order to extend drug exclusivity. Using investigative sites in CEE for phase 1b to phase 4 clinical studies can ensure that studies are completed on time or ahead of time. Many sponsors are hesitant to use sites in CEE because they do not understand how to get predictable results, or because they have biases against anything outside of the US or Western Europe. This is known as the “streetlight effect.” As a result, less than 2% of all clinical studies take place in CEE. The goal of my presentation is to take out the mystery of conducting studies in CEE. I will describe the healthcare system, centralized medicine, which funnels patients into relatively few sites and encourages patient retention. I will explain why patients in CEE are eager to participate in clinical studies. I will explain why physicians are motivated to be the top enrolling sites. I will cover why the data from these sites is higher quality than data from other geographies. Finally, I will explain that while study-startup times are somewhat longer, they are predictable (unlike other geographies).

Biography:

Mohammadreza Sattari has completed his PhD from the School of Medicine of Cardiff University in the UK. He is a Clinical Toxicologist, Professor and Director of a research team focusing on clinical trials and bioequivalence studies at the Faculty of Pharmacy and hospitals of Tabriz University of Medical Sciences. He has published more than 50 papers in reputed journals and serving as an Editorial Board Member of repute.

Abstract:

The aim of the present study was to determine the concentrations of nitroglycerin(glyceryl trinitrate, GTN, CAS 55-63-0) and its two main stable metabolites;1,2-dinitroglycerin (1,2-glyceryl dinitrate, GDN, CAS 621-65-8) and 1,3-dinitroglycerin(1,3-GDN, CAS 623-87-0) in human plasma using a capillary gas chromatography method with an electron capture detection. Using the GC conditions, linear calibrations were obtained for 1,3-GDN from 0.14 to 3 ng/mL, for 1,2-GDN from 0.06 to 6 ng/mL, and for GTN from 0.01 to0.3 ng/mL in plasma samples by the following calibration curve equations:[y=0.1924x–0.0088 (r2=0.999)],[y=0.2273x+0.0164 (r2=0.995)],[y=17.434x–0.0751] for 1,3-GDN, 1,2-GDN, and GTN respectively. The calculated limits of quantification values for GTN, 1,2-GDN, and 1,3-GDN were 0.03 ng/mL, 0.2 ng/mL, and 0.15 ng/mL respectively. This method was verified with a bioequivalence study of an Iranian brand of oral sustained release nitroglycerin with an innovator formulation.

Biography:

Hetal Shah is a Pharmacologist with over 12 years of first-hand experience in the field of Medical Writing and Clinical Research Project Management. She is a Gold medalist and a PhD holder awarded by the Gujarat University. She has 20 odd publications to her credit including book chapters, research papers and review articles in national as well as international journals. She is a medical writing expert with high standards for quality and work ethics. She is extensively involved in developing scientific and regulatory documentation and publications for various international and national Pharmaceuticals & CROs. She is also an experienced trainer with practical approach to coaching, and conducts medical writing workshops customized for various topics and audiences’ needs. She is a member of the executive committee of All India Medical Writers Association (AIMWA) and the DIA Medical Writing Group of India.

Abstract:

Medical writing has now evolved from being a sub-specialty service to a full-fledged line of business in the Healthcare Industry. A lucrative career option in itself, medical writing offers avenues not only as individual contributors, but also leadership and managerial positions. While, typically, medical writers develop documents individually or as a team, it would be worth extrapolating and comparing medical writing as an operation and treating each assignment as a project. With this, principles of project management usually applied to operational scenario can also be implemented to Medical writing profile and projects to further ease out and systematize the medical writing as a function. In medical writing, it is estimated that while 60% of a writer’s job is actually writing, 40% is project management. Hence, besides being technically equipped to execute the core activity i.e. draft the required document, project management skills are also desired in a medical writer. Project management is the application of knowledge, skills and techniques to execute projects effectively and efficiently. The concept of project management revolves around balancing The Triple constraints – Time, Scope, Cost; keeping Quality as the core. The discipline of project management is about providing the tools and techniques that enable the project team to organize their work to meet these constraints. Project management processes falls into five categories – Initiation, Planning & Design, Executing, Monitoring and Controlling, and Close-out. This presentation shall describe the extrapolation of project management concepts to Medical Writing as a function, and involve discussion on each aspect of project lifecycle in lines of a medical writing project, and a step-wise schedule of events/activities for handling a medical writing assignment from initiation to close.

Biography:

Nazila Bazrafshan has completed her M.Sc. in industrial engineering at Yazd University, Iran, in 2015. Her research interests are cancer treatment planning and medical decision-making.

Abstract:

Clinical trials play an increasingly important role in determining how treatment regimens are effective and safe. Treatment trials are the most common type of trials aimed at finding the best treatments causing the minimal side effects. They serve as a standard technique for evaluating chemotherapy treatment plans used to improve cancer treatment and care. Adaptive trials, on the other hand, test sequential treatments to select the appropriate treatment regimen in accordance with the patient’s condition. In fact, the intensity of advising the treatment regimen varies in response to the patient’s needs. We propose such a design using a Markov decision process (MDP) model for selecting the optimal policy of cancer chemotherapy treatment regimen according to the patient’s condition. The developed MDP model employs novel optimal cancer chemotherapy treatment regimens resulted from an optimization model which relies on previously published clinical trials. In this way, the MDP model benefits from the results of optimization model which propose the most-promising and cost-effective new chemotherapy combinations. Hence, the proposed approach takes the impact of the patient’s response to the treatment regimen into account and proposes the most-promising dynamic treatment regimens also costing reasonable. Results show that the proposed approach yields the optimal sequence of chemotherapy treatment regimens for a period of chemotherapy treatment which makes possible designing clinical trials for sequential treatments. Comparing to the existing implemented clinical trials, we show that our proposed design significantly improves both health outcomes and treatment costs of patients.

Biography:

Deepti Goel is M.Pharm (Pharmacology) and certified PMP (from world renowned institute, PMI International) by training with over 15 years of experience in Clinical Research specializing in the areas of Project Management and sponsor liasoning, People Management, GCP and regulatory training, S i t e training and development, SOPs creation and up gradation, GCP-Audits of sites.

Abstract:

A clinical trial site is an epicenter of clinical research, as the core action of clinical research in terms of subject screening, recruitment, retention, medical care and data entry etc. happens here. Alone a site can achieve nothing if not partnered by a committed, experienced and quality cautious investigator. But natural, they are the biggest stakeholders and success of any clinical trial rests heavily on them. Time and again sponsors and Clinical Research Organizations (CROs) have tried and used various parameters to assess and evaluate a site. These parameters have been subjective, objective, and pragmatic. With effect from the year 2013, Indian regulatory law, Schedule Y has enhanced the roles and responsibilities of Investigators and Institution's watchdog, i.e. Ethics Committee, which in turn has made a ‘‘site’’ more accountable. It is evident that the key stakeholders, e.g. sponsors, CROs, and regulators, are looking for objective data to support decisions like, which sites are the best and serve as long-term partners. After all, relationship between a sponsor and a site/investigator, if turns out be a win–win, goes a long way. It is imperative that site identifies its core action points, monitors its performance and improve. Having spent considerable years at sponsors/CROs and sites, author strongly believes that some data points need to be identified to assess site’s quality and functionality. We have attempted to lay down some practical yet important top metrics (data points), site should focus on as part of their own continuous improvement initiatives and also help decision makers like sponsor/CROs to get the right results by choosing the right clinical site.

Biography:

Dr. Mistry is working as a Head Quality Assurance at Ahmadabad and Vadodara for BA/BE and Clinical Trials. He is doctorate in Chemistry and also Post Graduate Diploma in Export Import Management with International Finance. Mr. Mistry has over more than 15 years of experience in the area of Quality Systems applied in Pharmacology as BA & BE studies, Clinical Trials (Phase I to Phase III), R&D scales batches, Bioanalytical research (in vivo analysis), Analytical research (In vitro analysis), Formulation and Development for new drug enlargement in the line with GxPs Like GLP, GCP, cGMP etc. Dr..Mistry joined Accutest Research Laboratories as a Head Quality Assurance in 2006. He was previously associated with several reputed CROs and Pharma Companies like Lambda Therapeutics Ltd, BA research India, Alembic Ltd., Cadila Pharmaceuticals Ltd. He is also engage with Gujarat University for Clinical Research courses as a visiting faculty which is a joint venture with GSBTM and Gujarat University.

Abstract:

It has been observed many times despite of quality system, clinical research division and organization suffering with major non compliance and critical observation from regulatory agency/Vendor. Management supposes to add more quality persons as a investment towards improvement of quality. More often there are several reason for failure to build up quality system like people selection, audit style, chronicle negligence, qualification of auditors, personal behavior, more adage procedures etc. However there are remedies to improve the discussed reason. People selection play major role as the selected auditor will be part of organization. Audit style can be evaluated and make changes to improve and audit as per requirement. Positive team building can add value but be conscious about right role assignment for QA towards the user department. Some of chronic negligence affects the quality with unattended area. Improve the same periodic review of process add advantage as a self inspection. Qualification is must required as per the requirement of role which will be assigning to the auditor, experience can be superseded qualification but minimum qualification should be as rule. Behavioral issues can lead the bad or good culture vice versa with different auditor and user department and add or reduce value in team building. So it can be conclude that there are reasons for failure of quality system but with proper evaluation and handling it can be converting in good quality system.

Biography:

Jasser Alzhrani has completed his Master degree at the age of 29 years from Boonshoft School of Medicine, Wright State University. He is the manager of Drug Information Center, KSMC, Ministry of Health, KSA.

Abstract:

The ClinicalTrials.gov web site supply an appropriate link to look up any study results, however quantitative analyses’ format cannot be downloaded. Thus the purpose is to directly download study results from this web site and provides a link to retrieve all of the results in a sheet format in order to be analyzed properly and by analyzing them, then we describe the clinical trial activity in the Arabian Peninsula. An expert validated the outcome classification algorithms that we used in this against classification. We created databases of the study results ready for analysis by identifying the studies by intervention, population, or outcome of interest. However, this study is simply based upon the information that is in ClinicalTrials.gov. Therefore, our conclusion is that expanding the usefulness of the ClinicalTrials.gov registry by having a database ready for analysis. The benefit from doing this is increases the speed of comparative research.

Biography:

Mr Anwar has been working as researcher and clinical trial coordinator at Mekelle University and Addis abab univerisyt in Ethiopia. For the last three years he was working in one of the largest clinicla trial, Folate project, in addis ababa univeristy which was under collaborational support from Masachuseetes General Hospital, USA. Currently, I am a PhD fellow at universiyt of south australia and working with gene-environmental interaction.

Abstract:

There is a developing consensus on the effectiveness of various interventions for mental disorders in low and middle income countries, and it has been proposed that the main task that remains is to scale up these interventions. In this context we aimed to look at the quality and extent of intervention trials for selected priority mental and neurological disorders in sub-Saharan Africa. We used Medline databases. Randomized or non randomized clinical trials for the treatment of schizophrenia, depression, maternal depression, bipolar disorder and epilepsy/seizure disorders that involve pharmacotherapy, psychotherapy and physical therapy were included. An extensive list of search terms that identified locations, disorders, interventions and study types were employed. The qualities of the trials were appraised using the single component quality assessment of the CONSORT-statement and the Jadad scale. From 1136 studies identified, only 34 trials that fulfilled inclusion criteria were used for quality analysis. Most studies were clinical trials of treatments for epilepsy and conducted after 2006. In terms of region, the majority of studies were conducted in South Africa (22 of the 34). Pharmacotherapeutic interventions (71%), and conducted at a single center (53%) predominated. In terms of methodological quality in relation to the Jadad scale, 82% fulfill criteria for good methodological quality with a score of 3-5. However, the methodological quality according to the CONSORT criteria was more mixed. The overall quality of clinical trials conducted in Sub-Saharan Africa is encouraging despite the limited number. However, important quality limitations remain and have not improved over time. Establishing clinical trial centers in these countries may be one approach to improve quality and quantity of trials.

Biography:

Azza Saleh RADWAN is a Prof. of Clin. and Chem. Path. at TBRI, she is delegated as Head of the Central Directorate for Research and Health Development (RHD) in MoHPH, she is holding Diploma in TQM in Healthcare from AUC and certified as an International Trainer in Research Ethics from USA. She is the Coordinator of the National REC and the Higher REC. She is the Vice Chair of Aswan Heart Center - Magdy Yacoub Foundation REC, Air Force Specialized Hospital IRB and AFCM- IRB, she is a Faculty member in the Armed Medical School for Research and Medical Ethics.

Abstract:

Clinical trials are widely conducted in Egypt and all of them get approval from the National Research Ethics Committee affiliated to the Egyptian Ministry of Health and Population (MoHP-REC). This committee has been created by a ministerial decree in 2007 and has been renewed several times lately in April 2015, it reviewed all clinical trials conducted in Egypt before their start and follow them through progress report every 3 months. Our National REC has FWA 00016183.

Biography:

Moustafa Abdou Elsyad has completed his PhD at the age of 31 years from Mansoura University and postdoctoral studies from Faculty of Dentistry, Mansoura University, Mansoura, Egypt. He is An Associate Professor, of Removable Prosthodontics, Faculty of Dentistry, Mansoura University, Mansoura, Egypt. He has published more than 18 papers in reputed journals and has been serving as a reviewer in reputed journals of high impact factor in the field of implant prosthodontics .

Abstract:

This study aimed to compare the influence of resilient liner and clip attachments for bar-implant retained mandibular overdentures on opposing maxillary ridge after 5 years of denture wearing. Thirty edentulous male patients received 2 implants in the anterior mandible after being allocated into 2 equal groups using balanced randomization. After 3 months, implants were connected with resilient bars. New maxillary complete dentures were then constructed and mandibular overdentures were retained to the bars with either clips (group I, GI) or silicone resilient liners (group II, GII). The prosthetic and soft tissue complications of the maxillary dentures were recorded 6 months (T6m), 1 year (T1), 3 years (T3) and 5 years (T5) after overdenture insertion. Traced rotational tomograms were used for measurements of maxillary alveolar bone loss (R). Change in R immediately before (T0) and after 5 years (T5) of overdenture insertion was calculated. Maxillary denture relining times and frequency of flabby anterior maxillary ridge occurred significantly more often in GI compared to GII. The change of R in anterior part of maxilla was significantly higher than change of R in posterior part in both groups. GI showed significant resorption of anterior residual ridge compared to GII. Relining times and frequencies of flabby ridge were significantly correlated with change in R. Within the limitations of this study, resilient liner attachments for bar-implant retained mandibular overdentures are associated with decreased resorption and flabbiness of maxillary anterior residual ridge and fewer maxillary denture relining times when compared to clip attachments.