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CompletedNCT03296072Updated Sep 16, 2020Results posted

In Situ Erosion Study to Investigate the Effectiveness of an Experimental Toothpaste

A Phase 3 interventional study of 0.254% w/w sodium fluoride and 5% KNO3 and 0.454% w/w stannous fluoride in Tooth Erosion, sponsored by GlaxoSmithKline. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-09-16.

Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
62
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Tooth Erosion

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03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.
  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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.
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
62 participants (actual)

Study arms

  • Experimental
    Test product

    Participants will apply a full ribbon of the test product (1.5 grams \[g\]) containing 0.254% w/w sodium fluoride and 5% KNO3.

    Drug: 0.254% w/w sodium fluoride and 5% KNO3

  • Active comparator
    Comparator Product

    Participants will apply a full ribbon of the comparator product (1.5 g orally) containing 0.454% w/w stannous fluoride.

    Drug: 0.454% w/w stannous fluoride

  • Placebo comparator
    Placebo Product

    Participants will apply a full ribbon of the placebo (1.5 g orally) containing 5% KNO3.

    Drug: 5% KNO3

Interventions

  • Drug0.254% w/w sodium fluoride and 5% KNO3

    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.

  • Drug0.454% w/w stannous fluoride

    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.

  • Drug5% KNO3

    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.

05

What researchers measure

Primary outcomes

  1. % 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.

    Time frame: After 4 hrs following single exposure of treatment

Secondary outcomes

  1. % 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.

    Time frame: After 4 hrs following single exposure of treatment

  2. 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.

    Time frame: After 4 hrs following single exposure of treatment

  3. % 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.

    Time frame: After 4 hrs following single exposure of treatment

  4. % 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.

    Time frame: After 4 hrs following single exposure of treatment

  5. 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.

    Time frame: After 4 hrs following single exposure of treatment

06

Results

Posted Feb 20, 2019

Participant flow

Participants were recruited from one center in United States of America.

Treatment Period 1
Participant flow — Treatment Period 1
MilestoneTest Product/Comparator Product/Placebo ProductTest Product/Placebo Product/Comparator ProductComparator Product/Test Product/Placebo ProductComparator Product/Placebo Product/ Test ProductPlacebo Product/Test Product/Comparator ProductPlacebo Product/Comparator Product/Test Product
Started101110101011
Completed101110101011
Not completed000000
Treament Period 1: Wash Out Period
Participant flow — Treament Period 1: Wash Out Period
MilestoneTest Product/Comparator Product/Placebo ProductTest Product/Placebo Product/Comparator ProductComparator Product/Test Product/Placebo ProductComparator Product/Placebo Product/ Test ProductPlacebo Product/Test Product/Comparator ProductPlacebo Product/Comparator Product/Test Product
Started101110101011
Completed101110101011
Not completed000000
Treament Period 2
Participant flow — Treament Period 2
MilestoneTest Product/Comparator Product/Placebo ProductTest Product/Placebo Product/Comparator ProductComparator Product/Test Product/Placebo ProductComparator Product/Placebo Product/ Test ProductPlacebo Product/Test Product/Comparator ProductPlacebo Product/Comparator Product/Test Product
Started101110101011
Completed101110101011
Not completed000000
Treament Period 2: Wash Out Period
Participant flow — Treament Period 2: Wash Out Period
MilestoneTest Product/Comparator Product/Placebo ProductTest Product/Placebo Product/Comparator ProductComparator Product/Test Product/Placebo ProductComparator Product/Placebo Product/ Test ProductPlacebo Product/Test Product/Comparator ProductPlacebo Product/Comparator Product/Test Product
Started101110101011
Completed101110101011
Not completed000000
Treament Period 3
Participant flow — Treament Period 3
MilestoneTest Product/Comparator Product/Placebo ProductTest Product/Placebo Product/Comparator ProductComparator Product/Test Product/Placebo ProductComparator Product/Placebo Product/ Test ProductPlacebo Product/Test Product/Comparator ProductPlacebo Product/Comparator Product/Test Product
Started101110101011
Completed101110101011
Not completed000000

Outcome measures

Primary% 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.

Time frame:
After 4 hrs following single exposure of treatment
Reported as:
Least squares mean · Percentage SMHR
% 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)
Percentage SMHRTest ProductPlacebo Product
% 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)29.67 ± 1.1221.98 ± 1.12
Statistical analysis
  • Test Product vs Placebo Product · ANOVA · p = <.0001 · Difference of least square mean: 7.69 · 95% CI 5.18 to 10.19Difference is first-named treatment minus second-named treatment such that a positive difference favors the first named treatment.
Secondary% 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.

Time frame:
After 4 hrs following single exposure of treatment
Reported as:
Least squares mean · Percentage RER
% 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)
Percentage RERTest ProductPlacebo Product
% 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)-23.65 ± 1.96-56.94 ± 1.96
Statistical analysis
  • Test Product vs Placebo Product · ANOVA · p = <.0001 · Difference of least square mean: 33.29 · 95% CI 28.89 to 37.68Difference is first-named treatment minus second-named treatment such that a positive difference favors the first named treatment.
SecondaryEnamel 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.

Time frame:
After 4 hrs following single exposure of treatment
Reported as:
Least squares mean · Microgram fluoride per square centimeter
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)
Microgram fluoride per square centimeterTest ProductPlacebo Product
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)2.98 ± 0.091.17 ± 0.09
Statistical analysis
  • Test Product vs Placebo Product · ANOVA · p = <.0001 · Difference of least square mean: 1.81 · 95% CI 1.59 to 2.04Difference is first-named treatment minus second-named treatment such that a positive difference favors the first named treatment.
Secondary% 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.

Time frame:
After 4 hrs following single exposure of treatment
Reported as:
Least squares mean · Percentage SMHR
% SMHR (Comparison of 1150 Ppm Fluoride and 5% KNO3 Dentifrice Relative to Comparator Containing 1100 Ppm Fluoride)
Percentage SMHRTest ProductComparator Product
% SMHR (Comparison of 1150 Ppm Fluoride and 5% KNO3 Dentifrice Relative to Comparator Containing 1100 Ppm Fluoride)29.67 ± 1.1222.10 ± 1.12
Statistical analysis
  • Test Product vs Comparator Product · ANOVA · p = <.0001 · Difference of least square mean: 7.57 · 95% CI 5.07 to 11.07Difference is first-named treatment minus second-named treatment such that a positive difference favors the first named treatment.
Secondary% 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.

Time frame:
After 4 hrs following single exposure of treatment
Reported as:
Least squares mean · Percentage RER
% RER (Comparison of 1150 Ppm Fluoride and 5% KNO3 Dentifrice Relative to Comparator Containing 1100 Ppm Fluoride)
Percentage RERTest ProductComparator Product
% RER (Comparison of 1150 Ppm Fluoride and 5% KNO3 Dentifrice Relative to Comparator Containing 1100 Ppm Fluoride)-23.65 ± 1.96-34.63 ± 1.96
Statistical analysis
  • Test Product vs Comparator Product · ANOVA · p = <.0001 · Difference of least square mean: 10.98 · 95% CI 6.58 to 15.37Difference is first-named treatment minus second-named treatment such that a positive difference favors the first named treatment.
SecondaryEFU (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.

Time frame:
After 4 hrs following single exposure of treatment
Reported as:
Least squares mean · Microgram fluoride per square centimeter
EFU (Comparison of 1150 Ppm Fluoride and 5% KNO3 Dentifrice Relative to Comparator Containing 1100 Ppm Fluoride)
Microgram fluoride per square centimeterTest ProductComparator Product
EFU (Comparison of 1150 Ppm Fluoride and 5% KNO3 Dentifrice Relative to Comparator Containing 1100 Ppm Fluoride)2.98 ± 0.092.01 ± 0.09
Statistical analysis
  • Test Product vs Comparator Product · ANOVA · p = <.0001 · Difference of least square mean: 0.97 · 95% CI 0.75 to 1.20Difference is first-named treatment minus second-named treatment such that a positive difference favors the first named treatment.

Adverse events

Collected over 4 hours. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Test Product0/62 (0%)0/62 (0%)8/62 (12.9%)
Comparator Product0/62 (0%)0/62 (0%)6/62 (9.7%)
Placebo Product0/62 (0%)0/62 (0%)10/62 (16.1%)
Most frequent other events
Showing 10 of 22
Most frequent other events
EventTest ProductComparator ProductPlacebo Product
Oral Mucosal ErthyemaGastrointestinal disorders2/620/621/62
NasopharyngitisInfections and infestations2/621/620/62
Dental cariesGastrointestinal disorders0/620/621/62
Lip haematomaGastrointestinal disorders1/620/620/62
Mouth ulcerationGastrointestinal disorders0/621/620/62
Oral DiscomfortGastrointestinal disorders0/620/621/62
Oral PainGastrointestinal disorders0/620/621/62
ToothacheGastrointestinal disorders1/620/621/62
BronchitisInfections and infestations0/620/621/62
Gastrointestinal Bactetial OvergrowthInfections and infestations0/620/621/62

Baseline characteristics

Safety Population included all randomized participants who received at least 1 dose of study treatment. This population was based on the treatment the participant actually received.

Age, Continuous
Age, Continuous(Years)Overall Participants
Mean43.4 ± 13.38
Sex: Female, Male
Sex: Female, Male(Participants)Overall Participants
Female45
Male17
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Overall Participants
Hispanic or Latino4
Not Hispanic or Latino58
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Overall Participants
American Indian or Alaska Native0
Asian5
Native Hawaiian or Other Pacific Islander0
Black or African American14
White42
More than one race1
Unknown or Not Reported0
07

Study locations

1 site
  • GSK Investigational Site
    Indianapolis, Indiana 46202, United States
08

References and documents

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 documents

  • Study protocol · Nov 7, 2017
  • Statistical analysis plan · Feb 27, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — IPD for this study will be made available via the Clinical Study Data Request site.

Supporting information: Study protocol, Sap, Icf, Csr

09

Registry details

Key details

Study ID
NCT03296072
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Sep 28, 2017
Start date
Nov 13, 2017
Primary completion
Jan 16, 2018
Completion
Jan 16, 2018
Results posted
Feb 20, 2019
Last update
Sep 16, 2020

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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