Tooth ErosionPhase 2NCT01128972
Evaluation of a Test Mouthwash and Dentifrice Regimen in an In-situ Model of Dental Erosion
A Phase 2 study testing Sodium fluoride, Sodium monoflurophosphate and Sterile water in people with Tooth Erosion, run by GlaxoSmithKline at 1 site in United States.
Trial summary
An in situ model will be used to evaluate and compare enamel remineralization of bovine enamel specimens. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Erosion
- What is being tested?
- Sodium fluoride, Sodium monoflurophosphate and Sterile water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Oct 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- An intact maxillary dental arch suitable for the retention of the palatal appliance and an intact mandibular dental arch - subjects may have fixed bridges replacing missing teeth
- No current active caries or periodontal disease that may compromise the study or the health of the subjects
- A gum base stimulated whole saliva flow rate greater than or equal to 0.8 mL/minute and an unstimulated whole saliva flow rate greater than or equal to 0.2 mL/minute
Who cannot join
- Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University School of Dentistry
Indianapolis, Indiana, 46202
About this study
An in situ model will be used to evaluate and compare enamel remineralization of bovine enamel specimens.
- Conditions
- Tooth Erosion
- Being tested
- Sodium fluoride, Sodium monoflurophosphate, Sterile water
- Keywords
- enamel erosion, tooth remineralization, tooth erosion
- Medical subject headings
- Tooth Erosion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium fluorideDrug
Test fluoride toothpaste and test fluoride mouth rinse
Sodium monoflurophosphateDrug
United Kingdom marketed fluoride toothpaste
Sterile waterDrug
Sterile water rinse
| Study group | Role | What they receive |
|---|---|---|
| Test Dentifrice + Test Mouth Rinse (MR) | Experimental | Test fluoride dentifrice and test fluoride MR Receives: Drug: Sodium fluoride |
| Test Dentifrice + Sterile Water Rinse | Experimental | Test fluoride dentifrice and sterile water rinse Receives: Drug: Sodium fluoride; Drug: Sterile water |
| Placebo Dentifrice + Test MR | Experimental | Placebo dentifrice and test fluoride rinse Receives: Drug: Sodium fluoride |
| Reference Dentifrice + Sterile Water Rinse | Active comparator | Marketed fluoride dentifrice with sterile water rinse Receives: Drug: Sodium fluoride; Drug: Sodium monoflurophosphate; Drug: Sterile water |
| Placebo Dentifrice + Sterile Water Rinse | Placebo comparator | Placebo dentifrice and sterile water rinse Receives: Drug: Sterile water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adjusted Mean Percent Net Erosion Resistance (NER) of Enamel Specimens Exposed to Test Dentifrice + Test MR Relative to: 1) Test Dentifrice+ Sterile Water Rinse 2) Reference Dentifrice+ Sterile Water Rinse 3) Placebo Dentifrice+ Sterile Water Rinse
Enamel specimens were exposed to dietary erosive challenge and set of five indentations within each specimen was measured. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine NER which compared the indentations values of enamel specimens at baseline (B), first erosive (E1) and second erosive challenge (E2). Percent NER was calculated by formula: [(E1-E2)/ (E1-B)]*100. Smaller the negative NER, better is treatment regimen in imparting resistance to enamel.
Measured: Baseline, 4 hours post treatment in each treatment period
Secondary outcomes (1)
Adjusted Mean Percentage Surface Microhardness (SMH) Recovery of Enamel Specimens Exposed to Test Dentifrice + Test MR Relative to: 1)Test Dentifrice+Sterile Water Rinse 2)Reference Dentifrice+Sterile Water Rinse 3)Placebo Dentifrice+ Sterile Water Rinse
SMH test was used to assess mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Percent SMH recovery was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first erosive challenge (E1) using formula: [(E1-R)/ (E1-B)]*100.
Measured: Baseline, 4 hours post treatment in each treatment period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2010 (estimated)
- Study startAug 2009
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tooth ErosionStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01128972
- Sponsor's protocol ID
- Z3480664
- Status last verified
- Dec 2014
- First submitted
- 30 Apr 2010
- Last updated
- 1 Jan 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Maggio B, Guibert RG, Mason SC, Karwal R, Rees GD, Kelly S, Zero DT. Evaluation of mouthrinse and dentifrice regimens in an in situ erosion remineralisation model. J Dent. 2010 Nov;38 Suppl 3:S37-44. doi: 10.1016/S0300-5712(11)70007-0.
PubMed 21256403
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Test Mouthwash and Dentifrice Regimen in an In-situ Model of Dental Erosion
- ClinicalTrials.gov ID
- NCT01128972
- Acronym / sponsor ID
- Z3480664
- Conditions
- Tooth Erosion
- Keywords
- enamel erosion, tooth remineralization, tooth erosion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 24 May 2010 (estimated)
- Results
- Posted 25 Apr 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An in situ model will be used to evaluate and compare enamel remineralization of bovine enamel specimens.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Test Dentifrice + Test Mouth Rinse (MR) | Experimental | Drug: Sodium fluorideTest fluoride dentifrice and test fluoride MR |
| Test Dentifrice + Sterile Water Rinse | Experimental | Drug: Sodium fluoride, Drug: Sterile waterTest fluoride dentifrice and sterile water rinse |
| Placebo Dentifrice + Test MR | Experimental | Drug: Sodium fluoridePlacebo dentifrice and test fluoride rinse |
| Reference Dentifrice + Sterile Water Rinse | Active comparator | Drug: Sodium fluoride, Drug: Sodium monoflurophosphate, Drug: Sterile waterMarketed fluoride dentifrice with sterile water rinse |
| Placebo Dentifrice + Sterile Water Rinse | Placebo comparator | Drug: Sterile waterPlacebo dentifrice and sterile water rinse |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- An intact maxillary dental arch suitable for the retention of the palatal appliance and an intact mandibular dental arch - subjects may have fixed bridges replacing missing teeth
- No current active caries or periodontal disease that may compromise the study or the health of the subjects
- A gum base stimulated whole saliva flow rate greater than or equal to 0.8 mL/minute and an unstimulated whole saliva flow rate greater than or equal to 0.2 mL/minute
Key exclusion criteria (1 listed)
- Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
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 |
|---|---|---|
| Sodium fluorideTest fluoride toothpaste and test fluoride mouth rinse | Drug | Placebo Dentifrice + Test MR, Reference Dentifrice + Sterile Water Rinse, Test Dentifrice + Sterile Water Rinse, Test Dentifrice + Test Mouth Rinse (MR) |
| Sodium monoflurophosphateUnited Kingdom marketed fluoride toothpaste | Drug | Reference Dentifrice + Sterile Water Rinse |
| Sterile waterSterile water rinse | Drug | Placebo Dentifrice + Sterile Water Rinse, Reference Dentifrice + Sterile Water Rinse, Test Dentifrice + Sterile Water Rinse |
Primary outcome
Adjusted Mean Percent Net Erosion Resistance (NER) of Enamel Specimens Exposed to Test Dentifrice + Test MR Relative to: 1) Test Dentifrice+ Sterile Water Rinse 2) Reference Dentifrice+ Sterile Water Rinse 3) Placebo Dentifrice+ Sterile Water Rinse
Time frame: Baseline, 4 hours post treatment in each treatment period
Enamel specimens were exposed to dietary erosive challenge and set of five indentations within each specimen was measured. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine NER which compared the indentations values of enamel specimens at baseline (B), first erosive (E1) and second erosive challenge (E2). Percent NER was calculated by formula: [(E1-E2)/ (E1-B)]*100. Smaller the negative NER, better is treatment regimen in imparting resistance to enamel.
1 secondary outcome
Adjusted Mean Percentage Surface Microhardness (SMH) Recovery of Enamel Specimens Exposed to Test Dentifrice + Test MR Relative to: 1)Test Dentifrice+Sterile Water Rinse 2)Reference Dentifrice+Sterile Water Rinse 3)Placebo Dentifrice+ Sterile Water Rinse
Time frame: Baseline, 4 hours post treatment in each treatment period.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21256403Maggio B, Guibert RG, Mason SC, Karwal R, Rees GD, Kelly S, Zero DT. Evaluation of mouthrinse and dentifrice regimens in an in situ erosion remineralisation model. J Dent. 2010 Nov;38 Suppl 3:S37-44. doi: 10.1016/S0300-5712(11)70007-0.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sodium fluoride, Sodium monoflurophosphate and Sterile water in people with Tooth Erosion, run by GlaxoSmithKline at 1 site in United States.
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 3 inclusion and 1 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 1 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 phase mean?
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?
Yes. Results are posted in the registry (first posted 25 Apr 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Adjusted Mean Percent Net Erosion Resistance (NER) of Enamel Specimens Exposed to Test Dentifrice + Test MR Relative to: 1) Test Dentifrice+ Sterile Water Rinse 2) Reference Dentifrice+ Sterile Water Rinse 3) Placebo Dentifrice+ Sterile Water Rinse (time frame: Baseline, 4 hours post treatment in each treatment period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01128972, which also lists 1 linked publication.
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 1 Jan 2015.