NEW EVIDENTIARY APPROACHES TO OLD CHALLENGES IN TMD/TMJ ARTHROPLASTY - - PowerPoint PPT Presentation

▶
new evidentiary approaches to old challenges in tmd tmj
SMART_READER_LITE
LIVE PREVIEW

NEW EVIDENTIARY APPROACHES TO OLD CHALLENGES IN TMD/TMJ ARTHROPLASTY - - PowerPoint PPT Presentation

Nov 08, 2022 112 likes •212 views

Lisa Torosyan, CDRH/FDA MDEpiNet, Oct 20, 2017 NEW EVIDENTIARY APPROACHES TO OLD CHALLENGES IN TMD/TMJ ARTHROPLASTY 1 TMD/TMJ Arthroplasty Biomarkers: Narrowing the Gap between Currently Available and Urgently Needed Poor predictability

slide-1
SLIDE 1

1

NEW EVIDENTIARY APPROACHES TO OLD CHALLENGES IN TMD/TMJ ARTHROPLASTY

Lisa Torosyan, CDRH/FDA MDEpiNet, Oct 20, 2017

slide-2
SLIDE 2

2

TMD/TMJ Arthroplasty Biomarkers: Narrowing the Gap between Currently Available and Urgently Needed

Ø Poor predictability of treatment outcomes as a main challenge:

Ø Inter-individual variability of TMD severity and clinical manifestations Ø Patient’s sex and other treatment outcome modifiers

Ø The need for diagnostic and prognostic TMJ Arthroplasty biomarkers:

Ø Intention-to-Treat (ITT) subpopulation for TMJ replacement Ø Predictive assessment of real-world device performance Ø Prevention and diagnostic/therapeutic management of adverse outcomes

Ø The promise of new (in silico) evidentiary approaches for facilitating Precision/Stratified Medicine applications to TMD/TMJ Arthroplasty

slide-3
SLIDE 3

3

TMJ – not just another joint:

genes involved in TMJ Abnormal Morphology and Osteoarthritis are also associated with Neurological Functions

Neurological Functions TMJ Morphology & Inflammation

Image created using Ingenuity Pathway Analysis

slide-4
SLIDE 4

4

TMD Heterogeneity:

a major factor that complicates treatment choices

Degenerative and ankylotic changes as indications for TMJ REPLACEMENT TMJ Osteoarthritis TMDs (eg, chronic pain – nociceptive, neuropathic, etc.)

slide-5
SLIDE 5

5

Patient-Procedure-Device Impacts

  • n TMJ Arthroplasty Outcomes:

faulty device or individual susceptibility?

Patient Procedure Device

?

?

slide-6
SLIDE 6

6

q GWAS hold great promise for advancing our understanding of the genetic contributions …, risk factors for susceptibility and prognosis, and the development of individualized dental [and craniofacial] medicine. q …however, we are still in the early stages of the translation of genomics to clinic [and regulatory] practice (Kim et al 2012).

The Great Promise of ‘Omic Research for TMD/TMJ Arthroplasty applications

slide-7
SLIDE 7

7

  • “A SNP in PTGS1 (rs3842803) showed the strongest association with global psychological
  • symptoms. However, … the SNP remained strongly associated only in African-Americans.”

High C

Demographic Challenges in TMD Biomarker Discovery,

  • r why pharmacogenetics needs pharmacoepidemiology
slide-8
SLIDE 8

8

Biomarker-based Evidentiary Approaches to TMD/TMJ Arthroplasty

ü Biological and clinical plausibility of study endpoints and biomarkers: ü Better understanding of molecular/mechanistic underpinnings ü Improved pre-selection of biomarker candidates for qualification and validation steps ü Clinical and regulatory relevance of putative TMD/TMJ Arthroplasty biomarkers: ü New druggable targets for different TMDs ü Well-defined target subpopulations (eg, ITT for TMJ Replacement) ü Proactive surveillance of adverse events in TMJ Arthroplasty ü Less burdensome and more effective preclinical testing of TMJ devices ü Cost/time-efficient solutions for TMD-related Precision Medicine applications (eg, biomarkers for individuals and sex/race-stratified subpopulations)

ü The guiding role of EPIDEMIOLOGIC EVIDENCE for effective discovery of biomarkers applicable to various subpopulations with TMD/TMJ Arthroplasty

slide-9
SLIDE 9

9

Pharmacoepidemiologic Promise

  • f Registry-based Networks

for TMD/TMJ Arthroplasty