title: Methods to validate tooth-supporting regenerative therapies.
abstract: In humans, microbially induced inflammatory periodontal diseases are the primary initiators that disrupt the functional and structural integrity of the periodontium (i.e., the alveolar bone, the periodontal ligament, and the cementum). The reestablishment of its original structure, properties, and function constitutes a significant challenge in the development of new therapies to regenerate tooth-supporting defects. Preclinical models represent an important in vivo tool to critically evaluate and analyze the key aspects of novel regenerative therapies, including (1) safety, (2) effectiveness, (3) practicality, and (4) functional and structural stability over time. Therefore, these models provide foundational data that supports the clinical validation and the development of novel innovative regenerative periodontal technologies. Steps are provided on the use of the root fenestration animal model for the proper evaluation of periodontal outcome measures using the following parameters: descriptive histology, histomorphometry, immunostaining techniques, three-dimensional imaging, electron microscopy, gene expression analyses, and safety assessments. These methods will prepare investigators and assist them in identifying the key end points that can then be adapted to later stage human clinical trials.
authors.affiliation: Department of Periodontics and Oral Medicine, School of Dentistry, University of Michigan, Ann Arbor, MI, USA.
authors.forename: Miguel
authors.initials: M
authors.lastname: Padial-Molina
authors.forename: Julie T
authors.initials: JT
authors.lastname: Marchesan
authors.forename: Andrei D
authors.initials: AD
authors.lastname: Taut
authors.forename: Qiming
authors.initials: Q
authors.lastname: Jin
authors.forename: William V
authors.initials: WV
authors.lastname: Giannobile
authors.forename: Hector F
authors.initials: HF
authors.lastname: Rios
mesh_terms: D000818:Animals; D001861:Bone Regeneration / Q000502:physiology; D016557:Guided Tissue Regeneration, Periodontal / Q000379:methods*; D006801:Humans; D051381:Rats; D044968:Regenerative Medicine / Q000379:methods*; D023822:Tissue Engineering / Q000379:methods*