Tooth ErosionNCT02533466
In Vivo Investigation of Initial Stages of Enamel Erosion
A study testing Sodium fluoride + potassium nitrate and Potassium nitrate in people with Tooth Erosion, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial summary
This exploratory study is designed to help develop a clinical model to measure the earlier stages of dietary acid medicated enamel loss. The study will use fluoride as positive control to explore the validity of this design. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Erosion
- What is being tested?
- Sodium fluoride + potassium nitrate and Potassium nitrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2015to 6 Nov 2015
- Phase
- Interventional
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
- Aged at least 18 years
- Good general and mental health with, in the opinion of the investigator or medically qualified designee no clinically significant and relevant abnormalities in medical history or upon oral examination.
- Absence of any condition that would impact the participant's safety or well-being, or affect the participant's ability to understand and follow study procedures and requirements.
- Two anterior maxillary teeth, without signs of toothwear or exposed dentine, facial restorations, abutments for fixed or removable partial dentures, full crowns or veneers, orthodontic bands or cracked enamel that would interfere with the study evaluations.
Who cannot join
- Pregnant or breast feeding women
- Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
- Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit
- Recent history (within the last year) of alcohol or other substance abuse
- Presence of a disease or medication which in the opinion of the investigator, will impact on assessments
- Gross periodontal disease, treatment of periodontal disease (including surgery) within 12 months of screening, scaling or root planning within 3 months of screening
Show all 9Show fewer
- Surface irregularities, discoloration due to trauma, restorations and hypo or hyperplasic areas which, in the opinion of the investigator or dental assessor, would prevent accurate impressions and grading
- Daily doses of a medication which, in the opinion of the investigator, could impact the assessment, for example acidic medications
- Any condition that would impact on the subject's safety or wellbeing or affect the individual's ability to understand and follow study procedures and requirements
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study to Investigate the Initial Stages of Enamel Erosion in Vivo
This exploratory study is designed to help develop a clinical model to measure the earlier stages of dietary acid medicated enamel loss. The study will use fluoride as positive control to explore the validity of this design.
- Conditions
- Tooth Erosion
- Being tested
- Sodium fluoride + potassium nitrate, Potassium nitrate
- 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 fluoride + potassium nitrateOther
Marketed toothpaste containing 1450ppm fluoride as sodium fluoride and 5% potassium nitrate
Potassium nitrateOther
Experimental toothpaste containing 5% potassium nitrate
| Study group | Role | What they receive |
|---|---|---|
| Test Product | Experimental | Subjects will apply a full ribbon of dentifrice and brush their teeth for 1 timed minute using a wetted toothbrush, swish the resulting slurry around the mouth for 30 seconds making sure it contacts the selected teeth, spit out slurry and rinse mouth for 10 seconds with water. Receives: Other: Sodium fluoride + potassium nitrate |
| Reference Product | Placebo comparator | Subjects will apply a full ribbon of dentifrice and brush their teeth for 1 timed minute using a wetted toothbrush, swish the resulting slurry around the mouth for 30 seconds making sure it contacts the selected teeth, spit out slurry and rinse mouth for 10 seconds with water. Receives: Other: Potassium nitrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Immediately Following an Acid Challenge
The impressions of the tooth surface were analysed using scanning electron microscopy (SEM) to investigate changes in the enamel surface topography to determine degree of early stage enamel erosion. Interrogation of the tooth surface via impressions using SEM followed by visual image analysis was used to investigate the enamel surface topography.
The Images were graded as follows:
- - No signs of surface erosive wear (no evidence of the "lock and key" structure)
- - Early signs of erosive surface changes
- - Mild signs of erosive surface changes (early signs of the "lock and key" structure).
- - Moderate signs of erosive surface changes
- - Severe signs of erosive surface changes ("lock and key" structure and enamel "pits") X - Not evaluable
Measured: Baseline, 30 minutes post dietary acid challenge
Secondary outcomes (9)
Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Following 2 Hours Post Acid Challenge.
The impressions of the tooth surface were analysed using scanning electron microscopy (SEM) to investigate changes in the enamel surface topography to determine degree of early stage enamel erosion. Interrogation of the tooth surface via impressions using SEM followed by visual image analysis was used to investigate the enamel surface topography.
The Images were graded as follows:
- - No signs of surface erosive wear (no evidence of the "lock and key" structure)
- - Early signs of erosive surface changes
- - Mild signs of erosive surface changes (early signs of the "lock and key" structure).
- - Moderate signs of erosive surface changes
- - Severe signs of erosive surface changes ("lock and key" structure and enamel "pits") X - Not evaluable
Measured: Baseline, 2 hours post acid challenge
Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Following 4 Hours Post Acid Challenge
The impressions of the tooth surface were analysed using scanning electron microscopy (SEM) to investigate changes in the enamel surface topography to determine degree of early stage enamel erosion. Interrogation of the tooth surface via impressions using SEM followed by visual image analysis was used to investigate the enamel surface topography.
The Images were graded as follows:
- - No signs of surface erosive wear (no evidence of the "lock and key" structure)
- - Early signs of erosive surface changes
- - Mild signs of erosive surface changes (early signs of the "lock and key" structure).
- - Moderate signs of erosive surface changes
- - Severe signs of erosive surface changes ("lock and key" structure and enamel "pits") X - Not evaluable
Measured: Baseline, 4 hours post acid challenge
Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Following 7 Hours Post Acid Challenge
The impressions of the tooth surface were analysed using scanning electron microscopy (SEM) to investigate changes in the enamel surface topography to determine degree of early stage enamel erosion. Interrogation of the tooth surface via impressions using SEM followed by visual image analysis was used to investigate the enamel surface topography.
The Images were graded as follows:
- - No signs of surface erosive wear (no evidence of the "lock and key" structure)
- - Early signs of erosive surface changes
- - Mild signs of erosive surface changes (early signs of the "lock and key" structure).
- - Moderate signs of erosive surface changes
- - Severe signs of erosive surface changes ("lock and key" structure and enamel "pits") X - Not evaluable
Measured: Baseline, 7 hours post acid challenge
Change From Baseline of Salivary Calcium Concentration at 30 Mins Post Dietary Acid Challenge
Saliva stored at 0 - 20°C was used for determining calcium concentration
Measured: Baseline, 30 mins post dietary acid challenge
Change From Baseline of Salivary Calcium Concentration 7 Hours Post Dietary Acid Challenge
Saliva stored at 0 - 20°C was used for determining calcium concentration
Measured: Baseline, 7 hours post dietary acid challenge
Change From Baseline of pH Measurement at 30 Mins Post Dietary Acid Challenge
Saliva stored at 0 - 20°C was used for determining pH
Measured: Baseline, 30 mins post dietary acid challenge
Change From Baseline of pH Measurement 7 Hours Post Dietary Acid Challenge
Saliva stored at 0 - 20°C was used for determining pH
Measured: Baseline, 7 hours post dietary acid challenge
Change From Baseline in Buffering Capacity at 30 Mins Post Dietary Acid Challenge
Saliva was collected and stored at 0 - 20°C. A Saliva-check Buffer Kit was used to determine the buffer capacity. The colourimetric assay yielded a coloured pattern on a paper diagnostic using a 0-12 scale where 0-5 was deemed to be very low, 6-9 was deemed low and 10-12 was deemed normal-high.
Measured: Baseline, 30 mins post dietary acid challenge
Change From Baseline in Buffering Capacity 7 Hours Post Dietary Acid Challenge
Saliva was collected and stored at 0 - 20°C. A Saliva-check Buffer Kit was used to determine the buffer capacity. The colourimetric assay yielded a coloured pattern on a paper diagnostic using a 0-12 scale where 0-5 was deemed to be very low, 6-9 was deemed low and 10-12 was deemed normal-high.
Measured: Baseline, 7 hours post dietary acid challenge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2015 (estimated)
- Study start1 Oct 2015
- Primary completion6 Nov 2015
- Study completion6 Nov 2015
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.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 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
- NCT02533466
- Sponsor's protocol ID
- 204739
- Status last verified
- Mar 2017
- First submitted
- 24 Aug 2015
- Last updated
- 2 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Investigate the Initial Stages of Enamel Erosion in Vivo
- ClinicalTrials.gov ID
- NCT02533466
- Acronym / sponsor ID
- 204739
- Conditions
- Tooth Erosion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2015
- Primary completion
- 6 Nov 2015 (actual)
- Study completion
- 6 Nov 2015 (actual)
- First posted
- 26 Aug 2015 (estimated)
- Results
- Posted 15 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This exploratory study is designed to help develop a clinical model to measure the earlier stages of dietary acid medicated enamel loss. The study will use fluoride as positive control to explore the validity of this design.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Product | Experimental | Other: Sodium fluoride + potassium nitrateSubjects will apply a full ribbon of dentifrice and brush their teeth for 1 timed minute using a wetted toothbrush, swish the resulting slurry around the mouth for 30 seconds making sure it contacts the selected teeth, spit out slurry and rinse mouth for 10 seconds with water. |
| Reference Product | Placebo comparator | Other: Potassium nitrateSubjects will apply a full ribbon of dentifrice and brush their teeth for 1 timed minute using a wetted toothbrush, swish the resulting slurry around the mouth for 30 seconds making sure it contacts the selected teeth, spit out slurry and rinse mouth for 10 seconds with water. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
- Aged at least 18 years
- Good general and mental health with, in the opinion of the investigator or medically qualified designee no clinically significant and relevant abnormalities in medical history or upon oral examination.
- Absence of any condition that would impact the participant's safety or well-being, or affect the participant's ability to understand and follow study procedures and requirements.
- Two anterior maxillary teeth, without signs of toothwear or exposed dentine, facial restorations, abutments for fixed or removable partial dentures, full crowns or veneers, orthodontic bands or cracked enamel that would interfere with the study evaluations.
Key exclusion criteria (9 listed)
- Pregnant or breast feeding women
- Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
- Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit
- Recent history (within the last year) of alcohol or other substance abuse
- Presence of a disease or medication which in the opinion of the investigator, will impact on assessments
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 fluoride + potassium nitrateMarketed toothpaste containing 1450ppm fluoride as sodium fluoride and 5% potassium nitrate | Other | Test Product |
| Potassium nitrateExperimental toothpaste containing 5% potassium nitrate | Other | Reference Product |
Primary outcome
Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Immediately Following an Acid Challenge
Time frame: Baseline, 30 minutes post dietary acid challenge
The impressions of the tooth surface were analysed using scanning electron microscopy (SEM) to investigate changes in the enamel surface topography to determine degree of early stage enamel erosion. Interrogation of the tooth surface via impressions using SEM followed by visual image analysis was used to investigate the enamel surface topography. The Images were graded as follows: 1. - No signs of surface erosive wear (no evidence of the "lock and key" structure) 2. - Early signs of erosive surface changes 3. - Mild signs of erosive surface changes (early signs of the "lock and key" structure). 4. - Moderate signs of erosive surface changes 5. - Severe signs of erosive surface changes ("lock and key" structure and enamel "pits") X - Not evaluable
9 secondary outcomes
Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Following 2 Hours Post Acid Challenge.
Time frame: Baseline, 2 hours post acid challenge
Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Following 4 Hours Post Acid Challenge
Time frame: Baseline, 4 hours post acid challenge
Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Following 7 Hours Post Acid Challenge
Time frame: Baseline, 7 hours post acid challenge
Change From Baseline of Salivary Calcium Concentration at 30 Mins Post Dietary Acid Challenge
Time frame: Baseline, 30 mins post dietary acid challenge
Change From Baseline of Salivary Calcium Concentration 7 Hours Post Dietary Acid Challenge
Time frame: Baseline, 7 hours post dietary acid challenge
Change From Baseline of pH Measurement at 30 Mins Post Dietary Acid Challenge
Time frame: Baseline, 30 mins post dietary acid challenge
Change From Baseline of pH Measurement 7 Hours Post Dietary Acid Challenge
Time frame: Baseline, 7 hours post dietary acid challenge
Change From Baseline in Buffering Capacity at 30 Mins Post Dietary Acid Challenge
Time frame: Baseline, 30 mins post dietary acid challenge
Change From Baseline in Buffering Capacity 7 Hours Post Dietary Acid Challenge
Time frame: Baseline, 7 hours post dietary acid challenge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 study testing Sodium fluoride + potassium nitrate and Potassium nitrate in people with Tooth Erosion, run by GlaxoSmithKline at 1 site in United Kingdom.
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 5 inclusion and 9 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 2 Aug 2017. 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 Kingdom. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jun 2017). 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?
Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Immediately Following an Acid Challenge (time frame: Baseline, 30 minutes post dietary acid challenge). 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 2 Aug 2017.