In Vivo Quantification of Dental Demineralisation Using OCT With and Without Esomeprazole

NCT00564330 | Completed Phase 1

• 1 other identifier: D9612L00118
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

Dental erosions in 30 male and female patients with proven abnormal gastrooesophageal reflux will be assessed clinically and using a novel optical coherence tomography (OCT) laser technique before and after double-blind randomization to antisecretory treatment with esomeprazole 20mg or placebo bid for 3 weeks. The primary objective is to quantify tooth substance loss as well as changes in optical reflectance and scattering of dental hard tissues with and without acid inhibition. Secondary objectives are: To compare standardised visual scoring with OCT quantification of reflux damage at the different time points on different teeth. To assess sex differences in OCT- quantified dental tissue loss.

Conditions

Tooth Erosion

Keywords

dental erosion; OCT; proton pump inhibitor

Outcome Measures

Primary Outcomes (1)

• Dental erosions by OCT

  3 weeks

Secondary Outcomes (1)

• OCT parameters

  3 weeks

Study Arms (2)

esomeprazole

ACTIVE COMPARATOR

Esomeprazole 20mg twice daily

Drug: Esomeprazole

placebo

PLACEBO COMPARATOR

Placebo tablet twice daily

Drug: Placebo

Interventions

Esomeprazole DRUG

20mg bid

Also known as: Nexium

esomeprazole

Placebo DRUG

Placebo bid

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Dental erosions with Lussi score greater than 1, diagnosed by dentist
• Provision of informed consent
• Male or female aged 18 or above years
• GORD defined by time with pH\<4 greater than 3.5% during 24 hours demonstrated by 24h-hour pH-metry in the last 6 months before the start of the study

You may not qualify if:

• Significant illness within 2 weeks of study begin as judged by investigator.
• Established or suspected non-reflux causes for dental erosions.
• Inability or unwillingness to give informed consent.
• Inability to attend all study.
• New dental treatment (including dental products) may not be begun from 2 weeks before study begin until the end of the study, except usual dental hygiene with usual toothpaste.
• Allergy to or other contraindication for treatment with esomeprazole.
• Substantial change or planned change in dietary pattern, esp. diets within 2 weeks of study start and for the duration of the entire study.
• Change or planned change in normal medication or use of herbal, mineral, vitamin preparations within 2 weeks of study start and until the end of the study.
• Congenital dental defects.
• Ongoing pregnancy or breast-feeding.

Sponsors & Collaborators

• Brain-Gut Research Group: lead
• Beckman Laser Institute University of California Irvine: collaborator

MeSH Terms

Conditions

Tooth Erosion

Interventions

Esomeprazole

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Tooth Wear

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Clive H. Wilder-Smith, MD

  Brain-Gut Research Group

  PRINCIPAL INVESTIGATOR

• Petra Wilder-Smith, Professor

  Beckman and Laser Institute, University of California, Irvine, USA

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2007
• First Posted: November 27, 2007
• Study Start: November 1, 2007
• Primary Completion: April 1, 2008
• Study Completion: May 1, 2008
• Last Updated: August 26, 2014

Record last verified: 2014-08