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  • 1. American Journal of Gastroenterology Quantification of dental erosions in patients with GERDusing Optical Coherence Tomography before and afterdouble-blind, randomised treatment with esomeprazole or placeboFoJournal: American Journal of Gastroenterology r Manuscript ID:draft Pe Manuscript Type:Randomized,controlled trials Keywords: dental erosions, Acid suppressive therapy, drug therapy, GERD Manuscript Section: Esophagus erRe viewScholarOne, 375 Greenbrier Drive, Charlottesville, VA, 22901

2. Page 1 of 25American Journal of Gastroenterology Wilder-Smith C et al Dental erosions in GERD Quantification of dental erosions in patients with GERD using Optical Coherence Tomography before and after double-blind, randomised treatment with esomeprazole or placebo Short running title: Dental erosions in GERD Clive H. Wilder-Smith1, Petra Wilder-Smith2, Hilari Kawakami-Wong2, Julia Voronets3, Kathy Osann4, Adrian Lussi3.Fo 1 Brain-Gut Research Group and Gastroenterology Group Practice, Bern, Switzerland rP 2 Beckman Laser Institute, University of California, Irvine, USA 3 Department of Preventive, Restorative and Pediatric Dentistry University of Bern, Bern, ee Switzerland 4 Medical School, University of California, Irvine, USA rR Address for correspondence: Clive H. Wilder-Smith, MD. Brain-Gut Research Group,ev Bubenbergplatz 11, CH-3011 Bern, Switzerland. Email: cws@braingut.com iew What is current knowledge: Dental erosions are increasingly discovered in GERD patients and are quite common Patients with dental erosions often have undiscovered GERD What is new here: Dental enamel erosion and demineralization can be reliably quantified using optical coherence tomography Significant dental enamel loss is seen within 3 weeks of observation without treatment Esomeprazole partly prevented this dental enamel loss.1 of 18 ScholarOne, 375 Greenbrier Drive, Charlottesville, VA, 22901 3. American Journal of Gastroenterology Page 2 of 25Wilder-Smith C et al Dental erosions in GERDAbstractDental erosion, the chemical dissolution of enamel without bacterial involvement, is anunderreported manifestation of gastroesophageal reflux disease (GERD), as well as ofrecurrent vomiting and dietary habits. It leads to loss of tooth substance, hypersensitivity,functional impairment and even tooth fracture. To date, dental erosions have only beenassessed using very basic visual methods and no evidence-based guidelines or studies existregarding the prevention or treatment of GERD-related dental erosions. In this randomized,double-blind study we used optical coherence tomography (OCT) to quantify dental tissueFodemineralization and enamel loss before and after 3 weeks of acid-suppressive treatmentwith esomeprazole 20 mg bid or placebo in 30 patients presenting to the Berne University rPDental Clinic with advanced dental erosions and an abnormal acid exposure by 24hesophageal pH-manometry (defined as >4% of 24h period with pH1 (see Table 1), exclusion of other causes for dental erosions (diet, psychiatric, bruxism, salivary abnormalities,vomiting), written patient informed consent,and documentation of increased gastroesophageal reflux defined as more than 4% of the 24h esophageal pH-metry period with a pH2/week), n patientsrPReflux disease 3.2 2 / 3.8 3 5.0 4 / 5.4 4questionnaire score pre/ eeafter 3-week treatment(max. score=60)(ref. 55)# rR24h esophageal pH-metry:% time pH1)(ref. 54)##mean SD2 of 3 ScholarOne, 375 Greenbrier Drive, Charlottesville, VA, 22901 22. Page 21 of 25American Journal of GastroenterologyWilder-Smith C et al Dental erosions in GERDTable 3: Pre- and post treatment enamel thickness and optical reflectance intensity Pre-treatment Post-treatmentChange Mean measured enamel thickness at probe location SEMEsomeprazole 2142.6 m 0.162135.4 m 0.167.2 m 0.16 *N=167 teethPlacebo2215.9 m 0.172200.6 m 0.17 15.3 m 0.18 *N= 193 teeth FoMean measured optical intensity at probe location SEMEsomeprazole 55.8879 dB 0.769054.7659 dB 0.7600 -1.1220 dB 0.7691 #rPN=167 teethPlacebo52.2864 dB + 0.540454.3454 dB + 0.5339 +2.0590 dB 0.5329 #eeN=193 teethrR*p=0.013#p=0.012ev iew 3 of 3ScholarOne, 375 Greenbrier Drive, Charlottesville, VA, 22901 23. American Journal of GastroenterologyPage 22 of 25 Wilder-Smith C et al Dental erosions in GERDFigure LegendsFigure 2: Typical in vivo OCT images of the same tooth before and after 3-week treatmentwith placebo showing pre-study enamel thickness and post-study enamel loss (green lines)Figure 3Figure 3a: In vivo OCT images with pseudo-color superimposition of the same tooth beforeand after 3-week treatment with placebo. The optical signal near the tooth surface has Foincreased as shown by the greater preponderance of green versus blue.rPFigure 3b: In vivo OCT images with pseudo-color superimposition of the same tooth beforeand after 3-week treatment with esomeprazole 20mg bid. The optical signal near the tootheesurface has decreased as shown by the reduced preponderance of red versus green. rR eview1 of 2 ScholarOne, 375 Greenbrier Drive, Charlottesville, VA, 22901 24. Page 23 of 25 American Journal of Gastroenterology Wilder-Smith C et al Dental erosions in GERDFigure 1: Study flowchartVisit number1