Tooth ErosionPhase 3NCT03296072
In Situ Erosion Study to Investigate the Effectiveness of an Experimental Toothpaste
A Phase 3 study testing 0.254% w/w sodium fluoride and 5% KNO3, 0.454% w/w stannous fluoride and 5% KNO3 in people with Tooth Erosion, run by GlaxoSmithKline at 1 site in United States.
Trial summary
This will be a randomized, controlled, single center, single- blind, 3 period, 3 treatment, cross-over, in situ design which consists of placing pre-eroded bovine enamel specimens intra orally using a palatal appliance and testing the remineralizing performance of the experimental (dentifrice containing 0.254 Percent… 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?
- 0.254% w/w sodium fluoride and 5% KNO3, 0.454% w/w stannous fluoride and 5% KNO3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Nov 2017to 16 Jan 2018
- Phase
- Phase 3
- 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
- Evidence of a personally signed and dated informed consent.
- Male and female participants who, at the time of screening, are between the ages of 18 and 65 years, inclusive.
- Participant who is willing and able to comply with scheduled visits, treatment plan, and other study procedures.
- 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 oral examination.
- Male participant able to father children and female participant of childbearing potential and at risk for pregnancy must agree to use a highly effective method of contraception throughout the study and for 5 days after the last dose of assigned treatment.
- Good oral health without lesions of the oral cavity that could interfere with the study evaluations.
Show all 9Show fewer
- Maxillary dental arch suitable for the retention of the palatal appliance
- Unstimulated salivary flow rate of at least 0.2 mL/minute and a stimulated salivary flow rate of at least 0.8 mL/minute.
- Understands and is willing, able and likely to comply with all study procedures and restrictions.
Who cannot join
- Participants who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or participants who are GSK employees directly involved in the conduct of the study.
- Participation in other studies involving investigational drug(s) within 30 days prior to screening visit.
- Participation in other studies involving investigational oral care or cosmetic products within 30 days prior to screening visit.
- Acute or chronic medical or psychiatric condition that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
- Pregnant female participant (self - reported).
- Breastfeeding female participant.
Show all 12Show fewer
- Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients. Unwilling or unable to comply with the lifestyle guidelines described in this protocol.
- Medication that may interfere significantly with the saliva flow in the judgment of the investigator. Should new medications that may interfere with the saliva flow be added, a second salivary flow test will be performed.
- Participant with any condition that would impact on their safety or wellbeing or affect their ability to understand and follow study procedures and requirements.
- Any sign of grossly carious lesions (active), moderate or severe periodontal conditions, or severe tooth wear. Participant presenting at screening with minor caries may continue in the study if their carious lesions are repaired prior to the first treatment visit of the study.
- Wears oral appliance or orthodontia (besides participants wearing permanent lower retainers, which are eligible).
- Recent history (within the last year) of alcohol or other substance abuse. Participant who has previously been enrolled in this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
GSK Investigational Site
Indianapolis, Indiana, 46202
About this study
Official title: A Randomized, Examiner Blind, Crossover, in Situ Erosion Study to Investigate the Efficacy of an Experimental Dentifrice in Remineralization of Previously Softened Enamel Compared to a Placebo Dentifrice
This will be a randomized, controlled, single center, single- blind, 3 period, 3 treatment, cross-over, in situ design which consists of placing pre-eroded bovine enamel specimens intra orally using a palatal appliance and testing the remineralizing performance of the experimental (dentifrice containing 0.254 Percent weight by weight [%, w/w] sodium fluoride (1150 parts per million [ppm] fluoride) and 5% KNO3 [potassium nitrate]), comparator (dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride) and placebo (Fluoride free placebo containing 5% KNO3 [0 ppm fluoride] ) dentifrices 2 and 4 hours (hrs) post treatment application, based on surface micro hardness measurements. This study will be carried out in healthy adults with a maxillary dental arch suitable for the retention of the palatal appliance.
Read the detailed description
The aim of this study is to investigate the performance of an experimental dentifrice formulation in promoting enamel remineralization and inhibiting post-treatment enamel demineralization in an in situ erosion model, in comparison with a fluoride-free placebo and with a marketed competitor dentifrice product. The study will have 4 visits, 1 screening visit to assess participants eligibility and 3 treatment visits to assess product efficacy, where the treatment product will be dispensed and used under the supervision of a suitably trained study site personnel. Prior to each treatment visit, there will be a washout period of a minimum of 3 days. During this period participants will use their own dentifrice for at least one day, and a fluoride free dentifrice (provided) for two days prior to the next scheduled visit (including in the morning of the scheduled visit) to minimize any carry-over effects of the fluoride toothpaste.
- Conditions
- Tooth Erosion
- Being tested
- 0.254% w/w sodium fluoride and 5% KNO3, 0.454% w/w stannous fluoride, 5% KNO3
- Medical subject headings
- Tooth Erosion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.254% w/w sodium fluoride and 5% KNO3Drug
Dentifrice containing 0.254% w/w sodium fluoride (1150 ppm fluoride) and 5% KNO3; plus 0.25% PVM/MA copolymer and 2.5% sodium lactate. Participants will brush it on the buccal surfaces of their natural teeth for 25 timed seconds and then swish the resulting toothpaste slurry around the mouth, without further brushing, for a timed period of 95 seconds. After expectorating the slurry, the participants will gently rinse their mouths with 15 millilitres [mL] of tap water for 10 seconds before expectorating again.
0.454% w/w stannous fluorideDrug
Dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants will brush it on the buccal surfaces of their natural teeth for 25 timed seconds and then swish the resulting toothpaste slurry around the mouth, without further brushing, for a timed period of 95 seconds. After expectorating the slurry, the participants will gently rinse their mouths with 15 mL of tap water for 10 seconds before expectorating again.
5% KNO3Drug
Fluoride free placebo dentifrice containing 5% KNO3 (0 ppm fluoride), 0.25% PVM/MA copolymer and 2.5% lactate. Participants will brush it on the buccal surfaces of their natural teeth for 25 timed seconds and then swish the resulting toothpaste slurry around the mouth, without further brushing, for a timed period of 95 seconds. After expectorating the slurry, the participants will gently rinse their mouths with 15 mL of tap water for 10 seconds before expectorating again.
| Study group | Role | What they receive |
|---|---|---|
| Test product | Experimental | Participants will apply a full ribbon of the test product (1.5 grams [g]) containing 0.254% w/w sodium fluoride and 5% KNO3. Receives: Drug: 0.254% w/w sodium fluoride and 5% KNO3 |
| Comparator Product | Active comparator | Participants will apply a full ribbon of the comparator product (1.5 g orally) containing 0.454% w/w stannous fluoride. Receives: Drug: 0.454% w/w stannous fluoride |
| Placebo Product | Placebo comparator | Participants will apply a full ribbon of the placebo (1.5 g orally) containing 5% KNO3. Receives: Drug: 5% KNO3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
% Surface Micro Hardness Recovery (SMHR; Comparison of 1150 Ppm Fluoride and 5% KNO3 Dentifrice Relative to a Fluoride Free Placebo Dentifrice to Enhance Remineralization of Enamel)
The %SMHR was calculated to assess the changes in mineralization status of enamel specimens. The mean indent length (micrometer) from five Knoop microindentations within each specimen was measured at baseline (B), after the first erosive challenge (E1), and after 2 and 4 hours intraoral phase (R). An increase in the indentation length compared to the baseline indicates softening of the enamel surface while decrease in the indentation length represents re-hardening of enamel surface. The %SMHR was calculated as : %SMHR = [(E1-R)/(E1-B)]*100. Greater values of %SMHR indicate that greater remineralization has occurred, thus higher values are more favorable.
Measured: After 4 hrs following single exposure of treatment
Secondary outcomes (5)
% Relative Erosion Resistance (RER; Comparison of 1150 Ppm Fluoride and 5% KNO3 Dentifrice Relative to a Fluoride Free Placebo Dentifrice to Inhibit Demineralization of Enamel)
The %RER was calculated to assess the ability of treated enamel specimens to provide a combined benefit in terms of enhanced remineralization and acid resistance of the enamel. The mean indent length (micrometer) from five Knoop microindentations within each specimen was measured at baseline (B), after the first erosive challenge (E1), and after the second erosive challenge (E2) (E2 is measured for after both 2 and 4 hours of remineralization). An increase in the indentation length compared to the baseline indicates softening of the enamel surface while decrease in the indentation length represents re-hardening of enamel surface. The %RER was calculated as : %RER = [(E1-E2)/ (E1-B)]*100. Higher values of %RER indicate greater resistance to erosion, thus higher values are more favorable.
Measured: After 4 hrs following single exposure of treatment
Enamel Fluoride Uptake (EFU; Comparison of 1150 Ppm Fluoride and 5% KNO3 Dentifrice Relative to a Fluoride Free Placebo Dentifrice to Promote Fluoride Uptake in Enamel)
The EFU was measured to determine the amount of fluoride incorporation into the model erosive lesions. Each enamel specimen drilled to a depth of approximately 100 μm using a microdrill, through the entire lesion (four cores per specimen). The enamel powder pooled from four drilling samples was then, dissolved in a known volume of perchloric acid and immediately analyzed for fluoride content using a calibrated fluoride specific electrode. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores and expressed as microgram fluoride per square centimeter (μgF/cm^2). Higher values of EFU indicate greater incorporation of fluoride into the enamel and are thus more favorable.
Measured: After 4 hrs following single exposure of treatment
% SMHR (Comparison of 1150 Ppm Fluoride and 5% KNO3 Dentifrice Relative to Comparator Containing 1100 Ppm Fluoride)
The %SMHR was calculated to assess the changes in mineralization status of enamel specimens. The mean indent length (micrometer) from five Knoop microindentations within each specimen was measured at baseline (B), after the first erosive challenge (E1), and after 2 and 4 hours intraoral phase (R). An increase in the indentation length compared to the baseline indicates softening of the enamel surface while decrease in the indentation length represents re-hardening of enamel surface. The %SMHR was calculated as: %SMHR = [(E1-R)/(E1-B)]*100. Greater values of %SMHR indicate that greater remineralization has occurred, thus higher values are more favorable.
Measured: After 4 hrs following single exposure of treatment
% RER (Comparison of 1150 Ppm Fluoride and 5% KNO3 Dentifrice Relative to Comparator Containing 1100 Ppm Fluoride)
The %RER was calculated to assess the ability of treated enamel specimens to provide a combined benefit in terms of enhanced remineralization and acid resistance of the enamel. The mean indent length (micrometer) from five Knoop microindentations within each specimen was measured at baseline (B), after the first erosive challenge (E1), and after the second erosive challenge (E2) (E2 is measured for after both 2 and 4 hours of remineralization). An increase in the indentation length compared to the baseline indicates softening of the enamel surface while decrease in the indentation length represents re-hardening of enamel surface. The %RER was calculated as : %RER = [(E1-E2)/ (E1-B)]*100. Higher values of %RER indicate greater resistance to erosion, thus higher values are more favorable.
Measured: After 4 hrs following single exposure of treatment
EFU (Comparison of 1150 Ppm Fluoride and 5% KNO3 Dentifrice Relative to Comparator Containing 1100 Ppm Fluoride)
The EFU was measured to determine the amount of fluoride incorporation into the model erosive lesions. Each enamel specimen drilled to a depth of approximately 100 μm using a microdrill, through the entire lesion (four cores per specimen). The enamel powder pooled from four drilling samples was then, dissolved in a known volume of perchloric acid and immediately analyzed for fluoride content using a calibrated fluoride specific electrode. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores and expressed as microgram fluoride per square centimeter (μgF/cm^2). Higher values of EFU indicate greater incorporation of fluoride into the enamel and are thus more favorable.
Measured: After 4 hrs following single exposure of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2017
- Study start13 Nov 2017
- Primary completion16 Jan 2018
- Study completion16 Jan 2018
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 62 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
- NCT03296072
- Sponsor's protocol ID
- 208166
- Status last verified
- Aug 2020
- First submitted
- 25 Sep 2017
- Last updated
- 16 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD for this study will be made available via the Clinical Study Data Request site.
Publications
Creeth JE, Burnett GR, Souverain A, Gomez-Pereira P, Zero DT, Lippert F, Hara AT. In situ efficacy of an experimental toothpaste on enamel rehardening and prevention of demineralisation: a randomised, controlled trial. BMC Oral Health. 2020 Apr 17;20(1):118. doi: 10.1186/s12903-020-01081-y.
PubMed 32303206
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Examiner Blind, Crossover, in Situ Erosion Study to Investigate the Efficacy of an Experimental Dentifrice in Remineralization of Previously Softened Enamel Compared to a Placebo Dentifrice
- ClinicalTrials.gov ID
- NCT03296072
- Acronym / sponsor ID
- 208166
- Conditions
- Tooth Erosion
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 13 Nov 2017 (actual)
- Primary completion
- 16 Jan 2018 (actual)
- Study completion
- 16 Jan 2018 (actual)
- First posted
- 28 Sep 2017 (actual)
- Results
- Posted 20 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This will be a randomized, controlled, single center, single- blind, 3 period, 3 treatment, cross-over, in situ design which consists of placing pre-eroded bovine enamel specimens intra orally using a palatal appliance and testing the remineralizing performance of the experimental (dentifrice containing 0.254 Percent weight by weight [%, w/w] sodium fluoride (1150 parts per million [ppm] fluoride) and 5% KNO3 [potassium nitrate]), comparator (dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride) and placebo (Fluoride free placebo containing 5% KNO3 [0 ppm fluoride] ) dentifrices 2 and 4 hours (hrs) post treatment application, based on surface micro hardness measurements. This study will be carried out in healthy adults with a maxillary dental arch suitable for the retention of the palatal appliance.
Detailed description
The aim of this study is to investigate the performance of an experimental dentifrice formulation in promoting enamel remineralization and inhibiting post-treatment enamel demineralization in an in situ erosion model, in comparison with a fluoride-free placebo and with a marketed competitor dentifrice product. The study will have 4 visits, 1 screening visit to assess participants eligibility and 3 treatment visits to assess product efficacy, where the treatment product will be dispensed and used under the supervision of a suitably trained study site personnel. Prior to each treatment visit, there will be a washout period of a minimum of 3 days. During this period participants will use their own dentifrice for at least one day, and a fluoride free dentifrice (provided) for two days prior to the next scheduled visit (including in the morning of the scheduled visit) to minimize any carry-over effects of the fluoride toothpaste.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test product | Experimental | Drug: 0.254% w/w sodium fluoride and 5% KNO3Participants will apply a full ribbon of the test product (1.5 grams [g]) containing 0.254% w/w sodium fluoride and 5% KNO3. |
| Comparator Product | Active comparator | Drug: 0.454% w/w stannous fluorideParticipants will apply a full ribbon of the comparator product (1.5 g orally) containing 0.454% w/w stannous fluoride. |
| Placebo Product | Placebo comparator | Drug: 5% KNO3Participants will apply a full ribbon of the placebo (1.5 g orally) containing 5% KNO3. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Evidence of a personally signed and dated informed consent.
- Male and female participants who, at the time of screening, are between the ages of 18 and 65 years, inclusive.
- Participant who is willing and able to comply with scheduled visits, treatment plan, and other study procedures.
- 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 oral examination.
- Male participant able to father children and female participant of childbearing potential and at risk for pregnancy must agree to use a highly effective method of contraception throughout the study and for 5 days after the last dose of assigned treatment.
Key exclusion criteria (12 listed)
- Participants who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or participants who are GSK employees directly involved in the conduct of the study.
- Participation in other studies involving investigational drug(s) within 30 days prior to screening visit.
- Participation in other studies involving investigational oral care or cosmetic products within 30 days prior to screening visit.
- Acute or chronic medical or psychiatric condition that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
- Pregnant female participant (self - reported).
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 |
|---|---|---|
| 0.254% w/w sodium fluoride and 5% KNO3Dentifrice containing 0.254% w/w sodium fluoride (1150 ppm fluoride) and 5% KNO3; plus 0.25% PVM/MA copolymer and 2.5% sodium lactate. Participants will brush it on the buccal surfaces of their natural teeth for 25 timed seconds and then swish the resulting toothpaste slurry around the mouth, without further brushing, for a timed period of 95 seconds. After expectorating the slurry, the participants will gently rinse their mouths with 15 millilitres [mL] of tap water for 10 seconds before expectorating again. | Drug | Test product |
| 0.454% w/w stannous fluorideDentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants will brush it on the buccal surfaces of their natural teeth for 25 timed seconds and then swish the resulting toothpaste slurry around the mouth, without further brushing, for a timed period of 95 seconds. After expectorating the slurry, the participants will gently rinse their mouths with 15 mL of tap water for 10 seconds before expectorating again. | Drug | Comparator Product |
| 5% KNO3Fluoride free placebo dentifrice containing 5% KNO3 (0 ppm fluoride), 0.25% PVM/MA copolymer and 2.5% lactate. Participants will brush it on the buccal surfaces of their natural teeth for 25 timed seconds and then swish the resulting toothpaste slurry around the mouth, without further brushing, for a timed period of 95 seconds. After expectorating the slurry, the participants will gently rinse their mouths with 15 mL of tap water for 10 seconds before expectorating again. | Drug | Placebo Product |
Primary outcome
% Surface Micro Hardness Recovery (SMHR; Comparison of 1150 Ppm Fluoride and 5% KNO3 Dentifrice Relative to a Fluoride Free Placebo Dentifrice to Enhance Remineralization of Enamel)
Time frame: After 4 hrs following single exposure of treatment
The %SMHR was calculated to assess the changes in mineralization status of enamel specimens. The mean indent length (micrometer) from five Knoop microindentations within each specimen was measured at baseline (B), after the first erosive challenge (E1), and after 2 and 4 hours intraoral phase (R). An increase in the indentation length compared to the baseline indicates softening of the enamel surface while decrease in the indentation length represents re-hardening of enamel surface. The %SMHR was calculated as : %SMHR = [(E1-R)/(E1-B)]*100. Greater values of %SMHR indicate that greater remineralization has occurred, thus higher values are more favorable.
5 secondary outcomes
% Relative Erosion Resistance (RER; Comparison of 1150 Ppm Fluoride and 5% KNO3 Dentifrice Relative to a Fluoride Free Placebo Dentifrice to Inhibit Demineralization of Enamel)
Time frame: After 4 hrs following single exposure of treatment
Enamel Fluoride Uptake (EFU; Comparison of 1150 Ppm Fluoride and 5% KNO3 Dentifrice Relative to a Fluoride Free Placebo Dentifrice to Promote Fluoride Uptake in Enamel)
Time frame: After 4 hrs following single exposure of treatment
% SMHR (Comparison of 1150 Ppm Fluoride and 5% KNO3 Dentifrice Relative to Comparator Containing 1100 Ppm Fluoride)
Time frame: After 4 hrs following single exposure of treatment
% RER (Comparison of 1150 Ppm Fluoride and 5% KNO3 Dentifrice Relative to Comparator Containing 1100 Ppm Fluoride)
Time frame: After 4 hrs following single exposure of treatment
EFU (Comparison of 1150 Ppm Fluoride and 5% KNO3 Dentifrice Relative to Comparator Containing 1100 Ppm Fluoride)
Time frame: After 4 hrs following single exposure of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32303206Creeth JE, Burnett GR, Souverain A, Gomez-Pereira P, Zero DT, Lippert F, Hara AT. In situ efficacy of an experimental toothpaste on enamel rehardening and prevention of demineralisation: a randomised, controlled trial. BMC Oral Health. 2020 Apr 17;20(1):118. doi: 10.1186/s12903-020-01081-y.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.
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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 3 study testing 0.254% w/w sodium fluoride and 5% KNO3, 0.454% w/w stannous fluoride and 5% KNO3 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 9 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 16 Sep 2020. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 20 Feb 2019). 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?
% Surface Micro Hardness Recovery (SMHR; Comparison of 1150 Ppm Fluoride and 5% KNO3 Dentifrice Relative to a Fluoride Free Placebo Dentifrice to Enhance Remineralization of Enamel) (time frame: After 4 hrs following single exposure of treatment). 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 NCT03296072, 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 16 Sep 2020.