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CompletedNCT00564330Updated Aug 26, 2014

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

A Phase 1/2 interventional study of Esomeprazole and Placebo in Tooth Erosion, sponsored by Brain-Gut Research Group. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-08-26.

Sponsored by Brain-Gut Research Group · Phase 1/2, Interventional, and Diagnostic

Phase
Phase 1/2
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

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

02

Conditions studied

  • Tooth Erosion

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Keywords

  • dental erosion
  • OCT
  • proton pump inhibitor
03

In context

Tooth Erosion

47 studies on the registry are indexed under Tooth Erosion; 7 are open to participants now.

This study's enrollment of 30 is close to the median of 33 across 33 interventional studies indexed under Tooth Erosion.

Browse Tooth Erosion studies →

Lead sponsor

Brain-Gut Research Group is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Dental erosions with Lussi score greater than 1, diagnosed by dentist
  2. Provision of
  3. Male or female aged 18 or above years
  4. 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

Exclusion criteria

Exclusion Criteria:

  1. Significant illness within 2 weeks of study begin as judged by investigator.
  2. Established or suspected non-reflux causes for dental erosions.
  3. Inadequate exclusion of other causes for dental erosions (diet, psychiatric, bruxism, salivary abnormalities, vomiting, etc).
  4. Inability or unwillingness to give .
  5. Inability to attend all study.
  6. 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.
  7. Allergy to or other for treatment with esomeprazole.
  8. Use of proton pump inhibitors in 2 weeks or other acid inhibitory drugs in 3 days before study inclusion.
  9. Substantial change or planned change in dietary pattern, esp. diets within 2 weeks of study start and for the duration of the entire study.
  10. 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.
  11. Congenital dental defects.
  12. Ongoing pregnancy or breast-feeding.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
30 participants (actual)

Study arms

  • Active comparator
    esomeprazole

    Esomeprazole 20mg twice daily

    Drug: Esomeprazole

  • Placebo comparator
    placebo

    Placebo tablet twice daily

    Drug: Placebo

Interventions

  • DrugEsomeprazole

    20mg bid

    Also known as: Nexium

  • DrugPlacebo

    Placebo bid

06

What researchers measure

Primary outcomes

  1. Dental erosions by OCT

    Time frame: 3 weeks

Secondary outcomes

  1. OCT parameters

    Time frame: 3 weeks

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 26, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00564330
Lead sponsor
Brain-Gut Research Group
Collaborators
Beckman Laser Institute University of California Irvine
Responsible party
Sponsor
First posted
Nov 27, 2007
Start date
Nov 2007
Primary completion
Apr 2008
Completion
May 2008
Last update
Aug 26, 2014

Study contacts

Clive H. Wilder-Smith, MD
principal investigator · Brain-Gut Research Group
Petra Wilder-Smith, Professor
study director · Beckman and Laser Institute, University of California, Irvine, USA

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.

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Discussion

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