Tooth ErosionPhase 1/2NCT00564330
In Vivo Quantification of Dental Demineralisation Using OCT With and Without Esomeprazole
A Phase 1/2 study testing Esomeprazole in people with Tooth Erosion, run by Brain-Gut Research Group.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tooth Erosion
- What is being tested?
- Esomeprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Nov 2007to May 2008
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Significant illness within 2 weeks of study begin as judged by investigator.
- Established or suspected non-reflux causes for dental erosions.
- Inadequate exclusion of other causes for dental erosions (diet, psychiatric, bruxism, salivary abnormalities, vomiting, etc).
- 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.
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- Allergy to or other contraindication for treatment with esomeprazole.
- Use of proton pump inhibitors in 2 weeks or other acid inhibitory drugs in 3 days before study inclusion.
- 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.
About this study
Official title: In Vivo Quantification of Dental Demineralisation Using Optical Coherence Tomography Before and After Double-blind, Randomised Treatment With Esomeprazole or Placebo of Patients With Dental Erosions
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
- Conditions
- Tooth Erosion
- Being tested
- Esomeprazole, Placebo
- Keywords
- dental erosion, OCT, proton pump inhibitor
- Medical subject headings
- Tooth Erosion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsomeprazoleDrug
Also called Nexium
20mg bid
PlaceboDrug
Placebo bid
| Study group | Role | What they receive |
|---|---|---|
| esomeprazole | Active comparator | Esomeprazole 20mg twice daily Receives: Drug: Esomeprazole |
| placebo | Placebo comparator | Placebo tablet twice daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dental erosions by OCT
Measured: 3 weeks
Secondary outcomes (1)
OCT parameters
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2007 (estimated)
- Study startNov 2007
- Primary completionApr 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth ErosionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brain-Gut Research Group
- Sponsor type
- University, hospital or other
- Collaborators
- Beckman Laser Institute University of California Irvine
- Responsible party
- Sponsor
- Investigators
- Clive H. Wilder-Smith, MD, Principal investigator, Brain-Gut Research GroupPetra Wilder-Smith, Professor, Study director, Beckman and Laser Institute, University of California, Irvine, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00564330
- Sponsor's protocol ID
- D9612L00118
- Status last verified
- Aug 2014
- First submitted
- 26 Nov 2007
- Last updated
- 26 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Quantification of Dental Demineralisation Using Optical Coherence Tomography Before and After Double-blind, Randomised Treatment With Esomeprazole or Placebo of Patients With Dental Erosions
- ClinicalTrials.gov ID
- NCT00564330
- Acronym / sponsor ID
- D9612L00118
- Conditions
- Tooth Erosion
- Keywords
- dental erosion, OCT, proton pump inhibitor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Brain-Gut Research GroupUniversity, hospital or other
- Collaborators
- Beckman Laser Institute University of California Irvine
- Study start
- Nov 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 27 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| esomeprazole | Active comparator | Drug: EsomeprazoleEsomeprazole 20mg twice daily |
| placebo | Placebo comparator | Drug: PlaceboPlacebo tablet twice daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- Significant illness within 2 weeks of study begin as judged by investigator.
- Established or suspected non-reflux causes for dental erosions.
- Inadequate exclusion of other causes for dental erosions (diet, psychiatric, bruxism, salivary abnormalities, vomiting, etc).
- Inability or unwillingness to give informed consent.
- Inability to attend all study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EsomeprazoleAlso: Nexium20mg bid | Drug | esomeprazole |
| PlaceboPlacebo bid | Drug | placebo |
Primary outcome
Dental erosions by OCT
Time frame: 3 weeks
1 secondary outcome
OCT parameters
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Esomeprazole in people with Tooth Erosion, run by Brain-Gut Research Group.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dental erosions by OCT (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2014.