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CompletedNCT01128972Updated Jan 1, 2015Results posted

Evaluation of a Test Mouthwash and Dentifrice Regimen in an In-situ Model of Dental Erosion

A Phase 2 interventional study of Sodium fluoride and Sodium monoflurophosphate 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 2015-01-01.

Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

An in situ model will be used to evaluate and compare enamel remineralization of bovine enamel specimens.

02

Conditions studied

  • Tooth Erosion

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Keywords

  • enamel erosion
  • tooth remineralization
  • tooth erosion
03

In context

Tooth Erosion

47 studies on the registry are indexed under Tooth Erosion; 7 are open to participants now.

This study's enrollment of 36 is close to the median of 33 across 33 interventional studies indexed under Tooth Erosion.

Browse Tooth Erosion studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 118 are open to participants now.

Of its 264 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.

Browse GlaxoSmithKline studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Known or suspected intolerance or to the study materials (or closely related compounds) or any of their stated ingredients
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Investigator)
Enrollment
36 participants (actual)

Study arms

  • Experimental
    Test Dentifrice + Test Mouth Rinse (MR)

    Test fluoride dentifrice and test fluoride MR

    Drug: Sodium fluoride

  • Experimental
    Test Dentifrice + Sterile Water Rinse

    Test fluoride dentifrice and sterile water rinse

    Drug: Sodium fluoride · Drug: Sterile water

  • Experimental
    Placebo Dentifrice + Test MR

    Placebo dentifrice and test fluoride rinse

    Drug: Sodium fluoride

  • Active comparator
    Reference Dentifrice + Sterile Water Rinse

    Marketed fluoride dentifrice with sterile water rinse

    Drug: Sodium fluoride · Drug: Sodium monoflurophosphate · Drug: Sterile water

  • Placebo comparator
    Placebo Dentifrice + Sterile Water Rinse

    Placebo dentifrice and sterile water rinse

    Drug: Sterile water

Interventions

  • DrugSodium fluoride

    Test fluoride toothpaste and test fluoride mouth rinse

  • DrugSodium monoflurophosphate

    United Kingdom marketed fluoride toothpaste

  • DrugSterile water

    Sterile water rinse

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: Baseline, 4 hours post treatment in each treatment period.

Other outcomes

  1. Adjusted Mean Percent NER of Enamel Specimens Exposed to a Treatment Regimen of Placebo Dentifrice + Test MR Relative to: 1) Test Dentifrice +Test MR 2) Test Dentifrice + Sterile Water Rinse 3) Reference 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.

    Time frame: Baseline, 4 hours post treatment in each treatment period

  2. Adjusted Mean Percentage SMH Recovery of Enamel Specimens Exposed to Test Dentifrice + Test MR Relative to Following Treatment Regimens: 1) Test Dentifrice +Test MR 2) Test Dentifrice + Sterile Water 3) Reference Dentifrice +Sterile Water

    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.

    Time frame: Baseline, 4 hours post treatment in each treatment period

  3. Adjusted Mean Percent NER of Enamel Specimens Exposed to Test Dentifrice +Sterile Water Rinse and Reference 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.

    Time frame: Baseline, 4 hours post treatment in each treatment period

  4. Adjusted Mean Percent SMH Recovery of Enamel Specimens Exposed to Test Dentifrice +Sterile Water Rinse and Reference 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.

    Time frame: Baseline, 4 hours post treatment in each treatment period

07

Results

Posted Apr 25, 2013

Participant flow

Participants were recruited at the clinical site.

Period I
Participant flow — Period I
MilestoneTest Dentifrice + Test Mouth Rinse (MR)Test Dentifrice + Sterile Water RinseReference Dentifrice + Sterile Water RinsePlacebo Dentifrice + Sterile Water RinsePlacebo Dentifrice + Test MR
Started77778
Completed77778
Not completed00000
Period II
Participant flow — Period II
MilestoneTest Dentifrice + Test Mouth Rinse (MR)Test Dentifrice + Sterile Water RinseReference Dentifrice + Sterile Water RinsePlacebo Dentifrice + Sterile Water RinsePlacebo Dentifrice + Test MR
Started77787
Completed77787
Not completed00000
Period III
Participant flow — Period III
MilestoneTest Dentifrice + Test Mouth Rinse (MR)Test Dentifrice + Sterile Water RinseReference Dentifrice + Sterile Water RinsePlacebo Dentifrice + Sterile Water RinsePlacebo Dentifrice + Test MR
Started77877
Completed77877
Not completed00000
Period IV
Participant flow — Period IV
MilestoneTest Dentifrice + Test Mouth Rinse (MR)Test Dentifrice + Sterile Water RinseReference Dentifrice + Sterile Water RinsePlacebo Dentifrice + Sterile Water RinsePlacebo Dentifrice + Test MR
Started78777
Completed78777
Not completed00000
Period V
Participant flow — Period V
MilestoneTest Dentifrice + Test Mouth Rinse (MR)Test Dentifrice + Sterile Water RinseReference Dentifrice + Sterile Water RinsePlacebo Dentifrice + Sterile Water RinsePlacebo Dentifrice + Test MR
Started87777
Completed87777
Not completed00000

Outcome measures

PrimaryAdjusted 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.

Time frame:
Baseline, 4 hours post treatment in each treatment period
Reported as:
Least squares mean · Percent NER
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
Percent NERTest Dentifrice + Test MRTest Dentifrice + Sterile Water RinseReference Dentifrice + Sterile Water RinsePlacebo Dentifrice + Sterile Water Rinse
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-2.88 ± 2.155-14.54 ± 2.155-29.48 ± 2.155-40.05 ± 2.155
Statistical analysis
  • Test Dentifrice + Test MR vs Test Dentifrice + Sterile Water Rinse · ANOVA · p = <0.0001 (No adjustments made for multiple comparisons as the primary comparison was pre-specified.) · Adjusted mean difference: 11.66 · 95% CI 7.09 to 16.24Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.
  • Test Dentifrice + Test MR vs Reference Dentifrice + Sterile Water Rinse · ANOVA · p = <0.0001 (No adjustments made for multiple comparisons as primary comparison was pre-specified.) · Adjusted mean difference: 26.6 · 95% CI 22.02 to 31.18Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.
  • Test Dentifrice + Test MR vs Placebo Dentifrice + Sterile Water Rinse · ANOVA · p = <0.0001 (No adjustments made for multiple comparisons as the primary comparison was pre-specified.) · Adjusted mean difference: 37.17 · 95% CI 32.59 to 41.74Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.
SecondaryAdjusted 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.

Time frame:
Baseline, 4 hours post treatment in each treatment period.
Reported as:
Least squares mean · Percent SMH
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
Percent SMHTest Dentifrice + Test MRTest Dentifrice + Sterile Water RinseReference Dentifrice + Sterile Water RinsePlacebo Dentifrice + Sterile Water Rinse
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 Rinse42.14 ± 1.39938.02 ± 1.39930.88 ± 1.39930.57 ± 1.399
Statistical analysis
  • Test Dentifrice + Test MR vs Test Dentifrice + Sterile Water Rinse · ANOVA · p = 0.0083 (No adjustments made for multiple comparisons as the primary comparison was pre-specified.) · Adjusted mean difference: 4.11 · 95% CI 1.07 to 7.15Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.
  • Test Dentifrice + Test MR vs Reference Dentifrice + Sterile Water Rinse · ANOVA · p = <0.0001 (No adjustments made for multiple comparisons as the primary comparison was pre-specified.) · Adjusted mean difference: 11.25 · 95% CI 8.22 to 14.29Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.
  • Test Dentifrice + Test MR vs Placebo Dentifrice + Sterile Water Rinse · ANOVA · p = <0.0001 (No adjustments made for multiple comparisons as the primary comparison was pre-specified.) · Adjusted mean difference: 11.56 · 95% CI 8.53 to 14.60Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.
Other pre-specifiedAdjusted Mean Percent NER of Enamel Specimens Exposed to a Treatment Regimen of Placebo Dentifrice + Test MR Relative to: 1) Test Dentifrice +Test MR 2) Test Dentifrice + Sterile Water Rinse 3) Reference 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.

Time frame:
Baseline, 4 hours post treatment in each treatment period
Reported as:
Least squares mean · Percent NER
Adjusted Mean Percent NER of Enamel Specimens Exposed to a Treatment Regimen of Placebo Dentifrice + Test MR Relative to: 1) Test Dentifrice +Test MR 2) Test Dentifrice + Sterile Water Rinse 3) Reference Dentifrice +Sterile Water Rinse
Percent NERPlacebo Dentifrice + Test MRTest Dentifrice + Test MRTest Dentifrice + Sterile Water RinseReference Dentifrice + Sterile Water RinsePlacebo Dentifrice + Sterile Water Rinse
Adjusted Mean Percent NER of Enamel Specimens Exposed to a Treatment Regimen of Placebo Dentifrice + Test MR Relative to: 1) Test Dentifrice +Test MR 2) Test Dentifrice + Sterile Water Rinse 3) Reference Dentifrice +Sterile Water Rinse-3.76 ± 2.155-2.88 ± 2.155-14.54 ± 2.155-29.48 ± 2.155-40.05 ± 2.155
Statistical analysis
  • Placebo Dentifrice + Test MR vs Test Dentifrice + Test MR · ANOVA · p = 0.7041 (No adjustments made for multiple comparisons as the primary comparison was pre-specified.) · Adjusted mean difference: -0.88 · 95% CI -5.46 to 3.69Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.
  • Placebo Dentifrice + Test MR vs Test Dentifrice + Sterile Water Rinse · ANOVA · p = <0.0001 (No adjustments made for multiple comparisons as the primary comparison was pre-specified.) · Adjusted mean difference: 10.78 · 95% CI 6.21 to 15.36Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.
  • Placebo Dentifrice + Test MR vs Reference Dentifrice + Sterile Water Rinse · ANOVA · p = <0.0001 (No adjustments made for multiple comparisons as the primary comparison was pre-specified.) · Adjusted mean difference: 25.72 · 95% CI 21.14 to 30.29Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
  • Placebo Dentifrice + Test MR vs Placebo Dentifrice + Sterile Water Rinse · ANOVA · p = <0.0001 (No adjustments made for multiple comparisons as the primary comparison was pre-specified.) · Adjusted mean difference: 36.29 · 95% CI 31.71 to 40.86Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.
Other pre-specifiedAdjusted Mean Percentage SMH Recovery of Enamel Specimens Exposed to Test Dentifrice + Test MR Relative to Following Treatment Regimens: 1) Test Dentifrice +Test MR 2) Test Dentifrice + Sterile Water 3) Reference Dentifrice +Sterile Water

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.

Time frame:
Baseline, 4 hours post treatment in each treatment period
Reported as:
Least squares mean · Percent SMH
Adjusted Mean Percentage SMH Recovery of Enamel Specimens Exposed to Test Dentifrice + Test MR Relative to Following Treatment Regimens: 1) Test Dentifrice +Test MR 2) Test Dentifrice + Sterile Water 3) Reference Dentifrice +Sterile Water
Percent SMHPlacebo Dentifrice + Test MRTest Dentifrice + Test MRTest Dentifrice + Sterile Water RinseReference Dentifrice + Sterile Water RinsePlacebo Dentifrice + Sterile Water Rinse
Adjusted Mean Percentage SMH Recovery of Enamel Specimens Exposed to Test Dentifrice + Test MR Relative to Following Treatment Regimens: 1) Test Dentifrice +Test MR 2) Test Dentifrice + Sterile Water 3) Reference Dentifrice +Sterile Water37.75 ± 1.39942.14 ± 1.39938.02 ± 1.39930.88 ± 1.39930.57 ± 1.399
Statistical analysis
  • Placebo Dentifrice + Test MR vs Test Dentifrice + Test MR · ANOVA · p = 0.0049 (No adjustments made for multiple comparisons as the primary comparison was pre-specified.) · Adjusted mean difference: -4.39 · 95% CI -7.43 to -1.35Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment
  • Placebo Dentifrice + Test MR vs Test Dentifrice + Sterile Water Rinse · ANOVA · p = 0.8571 (No adjustments made for multiple comparisons as the primary comparison was pre-specified.) · Adjusted mean difference: -0.28 · 95% CI -3.31 to 2.76Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
  • Placebo Dentifrice + Test MR vs Reference Dentifrice + Sterile Water Rinse · ANOVA · p = <0.0001 (No adjustments made for multiple comparisons as the primary comparison was pre-specified.) · Adjusted mean difference: 6.87 · 95% CI 3.83 to 9.90Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.
  • Placebo Dentifrice + Test MR vs Placebo Dentifrice + Sterile Water Rinse · ANOVA · p = <0.0001 (No adjustments made for multiple comparisons as the primary comparison was pre-specified.) · Adjusted mean difference: 7.17 · 95% CI 4.14 to 10.21Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
Other pre-specifiedAdjusted Mean Percent NER of Enamel Specimens Exposed to Test Dentifrice +Sterile Water Rinse and Reference 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.

Time frame:
Baseline, 4 hours post treatment in each treatment period
Reported as:
Least squares mean · Percent NER
Adjusted Mean Percent NER of Enamel Specimens Exposed to Test Dentifrice +Sterile Water Rinse and Reference Dentifrice +Sterile Water Rinse
Percent NERTest Dentifrice + Sterile Water RinseReference Dentifrice + Sterile Water Rinse
Adjusted Mean Percent NER of Enamel Specimens Exposed to Test Dentifrice +Sterile Water Rinse and Reference Dentifrice +Sterile Water Rinse-2.88 ± 2.155-29.48 ± 2.155
Statistical analysis
  • Test Dentifrice + Sterile Water Rinse vs Reference Dentifrice + Sterile Water Rinse · ANOVA · Adjusted mean difference: 14.94 · 95% CI 10.36 to 19.51Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.
Other pre-specifiedAdjusted Mean Percent SMH Recovery of Enamel Specimens Exposed to Test Dentifrice +Sterile Water Rinse and Reference 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.

Time frame:
Baseline, 4 hours post treatment in each treatment period
Reported as:
Least squares mean · Percent SMH
Adjusted Mean Percent SMH Recovery of Enamel Specimens Exposed to Test Dentifrice +Sterile Water Rinse and Reference Dentifrice +Sterile Water Rinse
Percent SMHTest Dentifrice + Sterile Water RinseReference Dentifrice + Sterile Water Rinse
Adjusted Mean Percent SMH Recovery of Enamel Specimens Exposed to Test Dentifrice +Sterile Water Rinse and Reference Dentifrice +Sterile Water Rinse38.02 ± 1.39930.88 ± 1.399
Statistical analysis
  • Test Dentifrice + Sterile Water Rinse vs Reference Dentifrice + Sterile Water Rinse · ANOVA · p = <0.0001 (No adjustments made for multiple comparisons as the primary comparison was pre-specified.) · Adjusted mean difference: 7.14 · 95% CI 4.11 to 10.18Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.

Adverse events

Collected over All AEs encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Test Dentifrice + Test MR—0/36 (0%)0/36 (0%)
Test Dentifrice + Sterile Water Rinse—0/36 (0%)1/36 (2.8%)
Reference Dentifrice + Sterile Water Rinse—0/36 (0%)2/36 (5.6%)
Placebo Dentifrice + Test MR—0/36 (0%)1/36 (2.8%)
Placebo Dentifrice + Sterile Water Rinse—0/36 (0%)0/36 (0%)
Most frequent other events
Most frequent other events
EventTest Dentifrice + Test MRTest Dentifrice + Sterile Water RinseReference Dentifrice + Sterile Water RinsePlacebo Dentifrice + Test MRPlacebo Dentifrice + Sterile Water Rinse
Gingival ErythemaGastrointestinal disorders0/361/362/361/360/36

Baseline characteristics

Age, Continuous
Age, Continuous(Years)All Study Participants
Mean37.0 ± 12.90
Sex: Female, Male
Sex: Female, Male(Participants)All Study Participants
Female19
Male17
Region of Enrollment
Region of Enrollment(Participants)All Study Participants
United States36
08

Study locations

1 site
  • Indiana University School of Dentistry
    Indianapolis, Indiana 46202, United States
09

References and documents

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 ↗
10

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 2009, a primary completion of Oct 2009 and a completion of Oct 2009. It does not say whether these dates are actual or estimated.

Results were first posted in Apr 2013, 3 years 6 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 30, 2010
First posted
May 24, 2010
Start
Aug 2009
Primary completionActual
Oct 2009
CompletionActual
Oct 2009
Results first posted
Apr 25, 2013
Last update
Jan 1, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 1, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01128972
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
May 24, 2010
Start date
Aug 2009
Primary completion
Oct 2009
Completion
Oct 2009
Results posted
Apr 25, 2013
Last update
Jan 1, 2015

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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