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CompletedNCT00708123Updated Apr 22, 2013Results posted

In Situ Caries of Fluoride Toothpastes

A Phase 3 interventional study of Sodium fluoride toothpaste and Placebo toothpaste in Healthy Subjects, Partial Denture Wearers and Caries, sponsored by GlaxoSmithKline. Completed. Open to participants aged 18 Years to 78 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-04-22.

Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 78 Years
Sex
All
01

Study summary

This study is to evaluate the effect of fluoride dentifrices on enamel with artificial caries lesions in an in situ model.

Read the detailed description

Topical fluorides have been proven to be clinically effective in the prevention of dental caries. It is generally agreed that anti-caries effect of fluoride (F) is mainly by decreasing the rate of enamel demineralization and enhancing the rate of enamel remineralization. An in-situ Surface Micro-hardness (SMH) test is widely used to evaluate enamel demineralization and remineralization during the caries process. The aim of this study was to evaluate the efficacy of toothpaste formulations containing fluoride from different sources [sodium fluoride (NaF) and sodium monofluorophosphate (NaMFP)] using an in situ caries model.

02

Conditions studied

  • Healthy Subjects
  • Partial Denture Wearers
  • Caries

Keywords

  • remineralization
  • enamel
  • fluoride
  • caries
  • in situ
03

In context

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

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

04

Who can participate

Ages eligible
18 Years to 78 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Consent: Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
  2. Age:Aged between 18 and 78 years.
  3. Compliance:Understands and is willing, able and likely to comply with all study procedures and restrictions.
  4. General Health:Good general health with (in the opinion of the investigator) no clinically significant and/or relevant abnormalities of medical history or oral examination that could interfere with subject safety during the study period.
  5. Diagnosis: Oral - i. Currently living in the Indianapolis area which is a fluoridated community (1 ppm F). ii. Currently wearing a removable mandibular partial denture with sufficient room in the posterior buccal flange area to accommodate two enamel specimens (required dimensions 12 x 7 millimeters (mm). iii. Willing and capable of wearing their removable partial dentures 24 hours per day during each two week treatment period. iv.All restorations in a good state of repair.
  6. Salivary Flow:Have a salivary flow rate in the range of normal values (unstimulated whole saliva flow rate = 0.2 ml/minute; gum base stimulated whole saliva flow rate = 0.8 ml/minute).

Exclusion criteria

Exclusion Criteria

  1. Pregnancy:Women who are known to be pregnant or who are intending to become pregnant over the duration of the study. No pregnancy test will be required.
  2. Breast-feeding:Women who are breast-feeding.
  3. Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
  4. Clinical Study/Experimental Medication:Participation in another clinical study or receipt of an investigational drug within 30 days of the first treatment visit, with the exception of study T3157495 where the wash in period prior to treatment is sufficient.
  5. Antibiotics:Currently taking antibiotics or have taken antibiotics in the 2 weeks prior to the screening visit.
  6. Fluoride:Taking fluoride supplements for medical reasons.
  7. Dental Health: Current active caries or periodontal disease that may compromise the study or health of the subjects.
  8. Personnel: a) A member of the site study staff, b) An employee of the sponsor, c) Any employee of any toothpaste manufacturer or their spouse or family member.
05

Study design

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

Study arms

  • Active comparator
    Sodium Fluoride (NaF) toothpaste[1350 parts per million(ppm)F]

    Participants to brush their natural teeth twice daily with a full ribbon of NaF toothpaste (1350 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.

    Drug: Sodium fluoride toothpaste

  • Experimental
    NaF/Carbopol toothpaste (1400 ppm F)

    Participants to brush their natural teeth twice daily with a full ribbon of NaF and 0.5% carbopol toothpaste (1450 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.

    Drug: Sodium fluoride toothpaste

  • Active comparator
    NaMFP/NaF toothpaste (1450 ppm F)

    Participants to brush their natural teeth twice daily with a full ribbon of NaMFPand NaF toothpaste (1450 ppm F - 1000 ppm F as NaMFP and 450 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.

    Drug: Sodium fluoride toothpaste

  • Active comparator
    NaF toothpaste (250 ppm F)

    Participants to brush their natural teeth twice daily with a full ribbon of NaF toothpaste (250 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.

    Drug: Sodium fluoride toothpaste

  • Placebo comparator
    Placebo toothpaste (0 ppm F)

    Participants to brush their natural teeth twice daily with a full ribbon of fluoride free toothpaste (0 ppm F) for one timed minute, after removing their partial denture from their mouth.

    Drug: Placebo toothpaste

Interventions

  • DrugSodium fluoride toothpaste

    Various fluoride toothpastes containing 1350 ppm F, 1450 ppm F, 1400 ppm F and 250 ppm F

    Also known as: Fluoride

  • DrugPlacebo toothpaste

    Fluoride free toothpaste (0 ppm F)

06

What researchers measure

Primary outcomes

  1. Mean Percentage Surface Microhardness Recovery (%SMHR) of Enamel Specimens Exposed to NaF/Carbopol Toothpaste (1400 ppmF), NaF Toothpaste (1350ppmF) Compared to NaMFP/NaF Toothpaste (1450ppmF)

    %SMHR test was used to assess mineralization status of enamel specimens using a Wilson 2100 Hardness tester. %SMHR 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. %SMHR was calculated from indentation values of enamel specimens at baseline (B), after intra-oral exposure (R) and after in-vitro demineralization (D) using formula: \[(D-R)/ (D-B)\]\*100.

    Time frame: Baseline to 14 days

Secondary outcomes

  1. Mean %SMHR of Enamel Specimens Exposed to NaF/Carbopol Toothpaste (1400 ppmF), NaF Toothpaste (1350ppmF), NaMFP/NaF Toothpaste (1450ppmF), NaF Toothpaste (250ppmF) and Placebo Toothpaste (0ppmF)

    %SMHR test was used to assess mineralization status of enamel specimens using a Wilson 2100 Hardness tester. %SMHR 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. %SMHR was calculated from indentation values of enamel specimens at baseline (B), after intra-oral exposure (R) and after in-vitro demineralization (D) using formula: \[(D-R)/ (D-B)\]\*100.

    Time frame: Baseline to 14 days

  2. Adjusted Mean Change From Baseline in Enamel Fluoride Uptake

    Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on the amount of fluoride (F) divided by the area of the enamel cores and expressed as ug F/cm2. The difference between treatments was calculated with respect to fluoride uptake by enamel.

    Time frame: Baseline to 14 days

07

Results

Posted Nov 19, 2012

Participant flow

Participants were recruited at the clinical site.

Period 1
Participant flow — Period 1
MilestoneSodium Fluoride (NaF) Toothpaste[1350 Parts Per Million(Ppm)F]NaF/Carbopol Toothpaste (1400 Ppm F)NaMFP/NaF Toothpaste (1450 Ppm F)NaF Toothpaste (250 Ppm F)Placebo Toothpaste (0 Ppm F)
Started1212121212
Completed1211111112
Not completed01110
Withdrew: Protocol violation01010
Withdrew: Adverse event00100
Period 2
Participant flow — Period 2
MilestoneSodium Fluoride (NaF) Toothpaste[1350 Parts Per Million(Ppm)F]NaF/Carbopol Toothpaste (1400 Ppm F)NaMFP/NaF Toothpaste (1450 Ppm F)NaF Toothpaste (250 Ppm F)Placebo Toothpaste (0 Ppm F)
Started1112121111
Completed1012121011
Not completed10010
Withdrew: Protocol violation00010
Withdrew: Other reason10000
Period 3
Participant flow — Period 3
MilestoneSodium Fluoride (NaF) Toothpaste[1350 Parts Per Million(Ppm)F]NaF/Carbopol Toothpaste (1400 Ppm F)NaMFP/NaF Toothpaste (1450 Ppm F)NaF Toothpaste (250 Ppm F)Placebo Toothpaste (0 Ppm F)
Started1210111210
Completed1210101110
Not completed00110
Withdrew: Lost to follow-up00110
Period 4
Participant flow — Period 4
MilestoneSodium Fluoride (NaF) Toothpaste[1350 Parts Per Million(Ppm)F]NaF/Carbopol Toothpaste (1400 Ppm F)NaMFP/NaF Toothpaste (1450 Ppm F)NaF Toothpaste (250 Ppm F)Placebo Toothpaste (0 Ppm F)
Started1012101011
Completed1011101011
Not completed01000
Withdrew: Protocol violation01000
Period 5
Participant flow — Period 5
MilestoneSodium Fluoride (NaF) Toothpaste[1350 Parts Per Million(Ppm)F]NaF/Carbopol Toothpaste (1400 Ppm F)NaMFP/NaF Toothpaste (1450 Ppm F)NaF Toothpaste (250 Ppm F)Placebo Toothpaste (0 Ppm F)
Started1010111110
Completed1010111110
Not completed00000

Outcome measures

PrimaryMean Percentage Surface Microhardness Recovery (%SMHR) of Enamel Specimens Exposed to NaF/Carbopol Toothpaste (1400 ppmF), NaF Toothpaste (1350ppmF) Compared to NaMFP/NaF Toothpaste (1450ppmF)

%SMHR test was used to assess mineralization status of enamel specimens using a Wilson 2100 Hardness tester. %SMHR 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. %SMHR was calculated from indentation values of enamel specimens at baseline (B), after intra-oral exposure (R) and after in-vitro demineralization (D) using formula: \[(D-R)/ (D-B)\]\*100.

Time frame:
Baseline to 14 days
Reported as:
Least squares mean · %SMHR
Mean Percentage Surface Microhardness Recovery (%SMHR) of Enamel Specimens Exposed to NaF/Carbopol Toothpaste (1400 ppmF), NaF Toothpaste (1350ppmF) Compared to NaMFP/NaF Toothpaste (1450ppmF)
%SMHRNaF/Carbopol Toothpaste (1400 Ppm F)NaF Toothpaste (1350 Ppm F)NaMFP/NaF Toothpaste (1450 Ppm F)
Mean Percentage Surface Microhardness Recovery (%SMHR) of Enamel Specimens Exposed to NaF/Carbopol Toothpaste (1400 ppmF), NaF Toothpaste (1350ppmF) Compared to NaMFP/NaF Toothpaste (1450ppmF)33.54 ± 1.7235.23 ± 1.7429.57 ± 1.72
Statistical analysis
  • NaF/Carbopol Toothpaste (1400 Ppm F) vs NaMFP/NaF Toothpaste (1450 Ppm F) · ANOVA · p = 0.0265 (No adjustment was made for multiple comparisons as primary comparisons were pre-defined.) · Adjusted mean difference: 3.97 · 95% CI 0.47 to 7.48Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
  • NaF Toothpaste (1350 Ppm F) vs NaMFP/NaF Toothpaste (1450 Ppm F) · ANOVA · p = 0.0017 (No adjustment was made for multiple comparisons as primary comparisons were pre-defined.) · Adjusted mean difference: 5.66 · 95% CI 2.15 to 9.18Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
SecondaryMean %SMHR of Enamel Specimens Exposed to NaF/Carbopol Toothpaste (1400 ppmF), NaF Toothpaste (1350ppmF), NaMFP/NaF Toothpaste (1450ppmF), NaF Toothpaste (250ppmF) and Placebo Toothpaste (0ppmF)

%SMHR test was used to assess mineralization status of enamel specimens using a Wilson 2100 Hardness tester. %SMHR 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. %SMHR was calculated from indentation values of enamel specimens at baseline (B), after intra-oral exposure (R) and after in-vitro demineralization (D) using formula: \[(D-R)/ (D-B)\]\*100.

Time frame:
Baseline to 14 days
Reported as:
Least squares mean · %SMHR
Mean %SMHR of Enamel Specimens Exposed to NaF/Carbopol Toothpaste (1400 ppmF), NaF Toothpaste (1350ppmF), NaMFP/NaF Toothpaste (1450ppmF), NaF Toothpaste (250ppmF) and Placebo Toothpaste (0ppmF)
%SMHRNaF/Carbopol Toothpaste (1400 Ppm F)NaF Toothpaste (1350ppm F)NaF Toothpaste (250 Ppm F)NaMFP/NaF Toothpaste (1450 Ppm F)Placebo Toothpaste (0 Ppm F)
Mean %SMHR of Enamel Specimens Exposed to NaF/Carbopol Toothpaste (1400 ppmF), NaF Toothpaste (1350ppmF), NaMFP/NaF Toothpaste (1450ppmF), NaF Toothpaste (250ppmF) and Placebo Toothpaste (0ppmF)33.54 ± 1.7235.23 ± 1.7424.98 ± 1.7229.57 ± 1.7222.05 ± 1.73
Statistical analysis
  • NaF/Carbopol Toothpaste (1400 Ppm F) vs NaF Toothpaste (1350ppm F) · ANOVA · p = 0.3413 (No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.) · Adjusted mean difference: -1.69 · 95% CI -5.19 to 1.80Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
  • NaF Toothpaste (1350ppm F) vs NaF Toothpaste (250 Ppm F) · ANOVA · p = <0.0001 (No adjustments made for multiple comparisons as the primary comparison was pre-specified.) · Adjusted mean difference: 10.26 · 95% CI 6.76 to 13.76Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
  • NaF Toothpaste (1350ppm F) vs Placebo Toothpaste (0 Ppm F) · ANOVA · p = <0.0001 (No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.) · Adjusted mean difference: 13.19 · 95% CI 9.69 to 16.68Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
  • NaF/Carbopol Toothpaste (1400 Ppm F) vs NaF Toothpaste (250 Ppm F) · ANOVA · p = <0.0001 (No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.) · Adjusted mean difference: 8.57 · 95% CI 5.09 to 12.05Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
  • NaF/Carbopol Toothpaste (1400 Ppm F) vs Placebo Toothpaste (0 Ppm F) · ANOVA · p = <0.0001 (No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.) · Adjusted mean difference: 11.50 · 95% CI 8.01 to 14.98Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
  • NaF Toothpaste (250 Ppm F) vs NaMFP/NaF Toothpaste (1450 Ppm F) · ANOVA · p = 0.0104 (No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.) · Adjusted mean difference: -4.59 · 95% CI -8.10 to -1.09Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
  • NaMFP/NaF Toothpaste (1450 Ppm F) vs Placebo Toothpaste (0 Ppm F) · ANOVA · p = <0.0001 (No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.) · Adjusted mean difference: 7.52 · 95% CI 4.04 to 11.01Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
  • NaF Toothpaste (250 Ppm F) vs Placebo Toothpaste (0 Ppm F) · ANOVA · p = 0.0986 (No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.) · Adjusted mean difference: 2.93 · 95% CI -0.55 to 6.41Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
SecondaryAdjusted Mean Change From Baseline in Enamel Fluoride Uptake

Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on the amount of fluoride (F) divided by the area of the enamel cores and expressed as ug F/cm2. The difference between treatments was calculated with respect to fluoride uptake by enamel.

Time frame:
Baseline to 14 days
Reported as:
Least squares mean · µg*F/cm^2
Adjusted Mean Change From Baseline in Enamel Fluoride Uptake
µg*F/cm^2NaF/ Carbopol Toothpaste (1400 Ppm F)NaF Toothpaste (1350ppm F)NaF Toothpaste (250 Ppm F)NaMFP/NaF Toothpaste (1450 Ppm F)Placebo Toothpaste (0 Ppm F)
Adjusted Mean Change From Baseline in Enamel Fluoride Uptake1283.13 ± 71.531333.09 ± 72.08680.20 ± 71.481086.39 ± 71.42435.58 ± 71.54
Statistical analysis
  • NaF/ Carbopol Toothpaste (1400 Ppm F) vs NaMFP/NaF Toothpaste (1450 Ppm F) · ANOVA · p = 0.0148 (No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.) · Adjusted mean difference: 196.74 · 95% CI 38.89 to 354.60Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
  • NaF Toothpaste (1350ppm F) vs NaMFP/NaF Toothpaste (1450 Ppm F) · ANOVA · p = 0.0024 (No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.) · Adjusted mean difference: 246.70 · 95% CI 88.30 to 405.10Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
  • NaF/ Carbopol Toothpaste (1400 Ppm F) vs NaF Toothpaste (1350ppm F) · ANOVA · p = 0.5328 (No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.) · Adjusted mean difference: -49.96 · 95% CI -207.62 to 107.71Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
  • NaF Toothpaste (250 Ppm F) vs NaMFP/NaF Toothpaste (1450 Ppm F) · ANOVA · p = <0.0001 (No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.) · Mean difference (final values): -406.19 · 95% CI -564.00 to -248.37Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
  • NaF/ Carbopol Toothpaste (1400 Ppm F) vs NaF Toothpaste (250 Ppm F) · ANOVA · p = <0.0001 (No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.) · Adjusted mean difference: 602.93 · 95% CI 445.97 to 759.90Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
  • NaF Toothpaste (1350ppm F) vs NaF Toothpaste (250 Ppm F) · ANOVA · p = <0.0001 (No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.) · Adjusted mean difference: 652.89 · 95% CI 495.05 to 810.72Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
  • NaF/ Carbopol Toothpaste (1400 Ppm F) vs Placebo Toothpaste (0 Ppm F) · ANOVA · p = <0.0001 (No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.) · Adjusted mean difference: 847.55 · 95% CI 690.54 to 1004.55Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
  • NaF Toothpaste (1350ppm F) vs Placebo Toothpaste (0 Ppm F) · ANOVA · p = <0.0001 (No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.) · Adjusted mean difference: 897.50 · 95% CI 739.92 to 1055.08Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
  • NaMFP/NaF Toothpaste (1450 Ppm F) vs Placebo Toothpaste (0 Ppm F) · ANOVA · p = <0.0001 (No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.) · Adjusted mean difference: 650.80 · 95% CI 493.61 to 808.00Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
  • NaF Toothpaste (250 Ppm F) vs Placebo Toothpaste (0 Ppm F) · ANOVA · p = 0.0024 (No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.) · Adjusted mean difference: 244.62 · 95% CI 87.62 to 401.61Difference is first named treatment minus second named treatment such that a positive difference favors 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
NaF/ Carbopol Toothpaste (1400 Ppm F)—0/56 (0%)4/56 (7.1%)
NaF Toothpaste (1350ppm F)—0/54 (0%)4/54 (7.4%)
NaMFP/NaF Toothpaste (1450 Ppm F)—0/55 (0%)1/55 (1.8%)
NaF Toothpaste (250 Ppm F)—0/56 (0%)1/56 (1.8%)
Placebo Toothpaste (0 Ppm F)—0/54 (0%)2/54 (3.7%)
Most frequent other events
Most frequent other events
EventNaF/ Carbopol Toothpaste (1400 Ppm F)NaF Toothpaste (1350ppm F)NaMFP/NaF Toothpaste (1450 Ppm F)NaF Toothpaste (250 Ppm F)Placebo Toothpaste (0 Ppm F)
NasopharyngitisInfections and infestations4/564/541/551/562/54

Baseline characteristics

Age Continuous
Age Continuous(years)All Study Participants
Mean67.31 ± 9.166
Sex: Female, Male
Sex: Female, Male(Participants)All Study Participants
Female33
Male27
Region of Enrollment
Region of Enrollment(participants)All Study Participants
United States60
08

Study locations

No study locations are listed for this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 22, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00708123
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Jul 2, 2008
Start date
Nov 2007
Primary completion
Apr 2008
Completion
Apr 2008
Results posted
Nov 19, 2012
Last update
Apr 22, 2013

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline

Oversight

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

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