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Establishment of a Dental Effects of Hypophosphatasia Registry Thesis

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Establishment of a Dental Effects of Hypophosphatasia Registry Thesis Establishment of a Dental Effects of Hypophosphatasia Registry Thesis Presented in Partial Fulfillment of the Requirements for the Degree Master of Science in the Graduate School of The Ohio State University By Jennifer Laura Winslow, DMD Graduate Program in Dentistry The Ohio State University 2018 Thesis Committee Ann Griffen, DDS, MS, Advisor Sasigarn Bowden, MD Brian Foster, PhD Copyrighted by Jennifer Laura Winslow, D.M.D. 2018 Abstract Purpose: Hypophosphatasia (HPP) is a metabolic disease that affects development of mineralized tissues including the dentition. Early loss of primary teeth is a nearly universal finding, and although problems in the permanent dentition have been reported, findings have not been described in detail. In addition, enzyme replacement therapy is now available, but very little is known about its effects on the dentition. HPP is rare and few dental providers see many cases, so a registry is needed to collect an adequate sample to represent the range of manifestations and the dental effects of enzyme replacement therapy. Devising a way to recruit patients nationally while still meeting the IRB requirements for human subjects research presented multiple challenges. Methods: A way to recruit patients nationally while still meeting the local IRB requirements for human subjects research was devised in collaboration with our Office of Human Research. The solution included pathways for obtaining consent and transferring protected information, and required that the clinician providing the clinical data refer the patient to the study and interact with study personnel only after the patient has given permission. Data forms and a custom database application were developed. Results: The registry is established and has been successfully piloted with 2 participants, and we are now initiating wider recruitment. Conclusion: The registry provides a mechanism for collecting data from many sources to achieve a sample size that will provide a thorough descriptive analysis of the effects of ii HPP on the mixed and permanent dentition as well as the effects of enzyme replacement therapy on the dentition. The registry has been successfully piloted and we are now initiating a wider recruitment. The registry could also serve as a pilot for data collections on other rare disease with dental implications. iii Dedication This document is dedicated to my husband, Chris Winslow, my family, and my research mentor, Dr. Ann Griffen. iv Acknowledgments I would like to thank my husband for supporting me and having endless amounts of patience while I worked countless hours. I would like to thank the members of my committee for their time and support on this project. I would like to thank my sister for allowing me to use pictures of my adorable nieces for the recruitment materials. I would also like to thank Dr. Heidi Steinkamp and Jodee Coldren. Without all of these people, I would not have been able to develop this registry. I hope for things to continue to develop with this registry once I have graduated and help find answers for those with hypophosphatasia. v Vita May 2008 .......................................................Paradise High School 2012…………………………………………B.S. Biology, CSU, Chico 2016…………………………………………D.M.D., Midwestern University, Glendale 2016 to present ..............................................Dental Resident, Division of Pediatric Dentistry, The Ohio State University Fields of Study Major Field: Dentistry vi Table of Contents Abstract ............................................................................................................................... ii Dedication .......................................................................................................................... iv Acknowledgments............................................................................................................... v Vita ..................................................................................................................................... vi Fields of Study ................................................................................................................... vi Table of Contents .............................................................................................................. vii List of Tables ..................................................................................................................... ix List of Figures ..................................................................................................................... x Chapter 1. Introduction ....................................................................................................... 1 Chapter 2. Methods ............................................................................................................ 7 Chapter 3. Results ............................................................................................................ 14 Chapter 4. Discussion ...................................................................................................... 21 Chapter 5. Conclusion ...................................................................................................... 26 Bibliography ..................................................................................................................... 27 Appendix A. Study Brochure. ........................................................................................... 29 vii Appendix B. HPP Forms for the Participant ..................................................................... 32 Appendix C. Tooth Collection Flyer ................................................................................ 40 Appendix D. HPP Forms for the Dentist .......................................................................... 42 viii List of Tables Table 1: Patient Demographics ......................................................................................... 14 Table 2: HPP History ........................................................................................................ 15 Table 3: Dental History from Participants ........................................................................ 17 Table 4: Tooth loss in the primary dentition ..................................................................... 18 Table 5: Occlusion ............................................................................................................ 20 ix List of Figures Figure 1: Radiograph of missing upper incisors ............................................................... 18 Figure 2: Picture of exfoliated lower incisors ................................................................... 18 Figure 3: Tooth Chart........................................................................................................ 19 x Chapter 1. Introduction Hypophosphatasia (HPP) is a rare inherited metabolic disease that occurs because of a mutation in the gene, ALPL [1]. This results in a loss of function of the enzyme tissue non-specific alkaline phosphatase (TNSALP) [1]. TNSALP plays an important role in the development of mineralized tissues including the dentition [1]. TNSALP loss of function results in accumulation of inorganic pyrophosphate (PPi) and other extracellular phosphorylated substrates, including pyridoxal 5’-phosphate (PLP), and phosphoethanolamine (PEA) [1, 2]. Inorganic pyrophosphate acts as an inhibitor of hydroxyapatite formation, so failure to hydrolyze PPi impairs skeletal and dental mineralization [1, 3]. HPP can be inherited in an autosomal dominant or recessive fashion [1]. The mutations that occur are mostly missense mutations [1], and over 300 mutations have been identified [4]. TNSALP is expressed mainly in bone, adrenal glands, liver, teeth, and kidneys [1]. HPP ranges from mild to severe, with greater severity occurring with earlier onset, [1] which is reflected in lower levels of serum alkaline phosphatase (ALP) activity [3]. It is now recognized that HPP severity is a spectrum, but it has historically been classified into six different forms, mostly based on the age of onset of systemic symptoms. The six different forms of HPP are: perinatal, benign prenatal, infantile, childhood, adult, and odontohypophosphatasia (odonto-HPP) [3]. Perinatal occurs in utero or at birth [2]. This form is the most severe form and results in stillbirths, as it is 1 fatal due to almost complete absence of bone mineralization [2]. Benign prenatal also occurs in utero and can be detected through bone-related symptoms in the prenatal stage. This results in poor skeletal mineralization, but is not fatal [2]. The infantile form occurs before six months of age [2]. Severe bone deformities, rickets, respiratory issues, craniosynostosis, hypercalcemia, and nephrocalcinosis occur in this form [2]. Epileptic seizures may develop due to the inability to dephosphorylate pyridoxyl phosphate, and indicates a poor prognosis of survival [2]. The mortality rate is approximately 50% in the infantile form due to respiratory failure [5]. The childhood form of HPP ranges in presentation from minor, with premature primary tooth loss as the only symptom, to moderate HPP-related rickets, short stature, delayed walking, and pain in the lower limbs [2]. The adult form of HPP was originally described as developing during middle age with the onset of skeletal symptoms [2]. However, more recent reports indicate that nearly all patients diagnosed with the adult form of HPP report a history of early primary tooth loss and even
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