A Phase 2 interventional study of NaF/ KNO3/isopentane Dentifrice and NaF/KNO3 Dentifrice in Dental Erosion, sponsored by GlaxoSmithKline. Completed. Open to participants aged 18 Years to 78 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-12-08.
Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Treatment
The purpose of this study is to determine whether an experimental fluoridated dentifrice is effective in the treatment of dental caries
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. Determination of fluoride uptake in-situ also provides better estimation of true fluoride bioavailability of fluoride dentifrice products. In this study, an in-situ remineralization fluoride uptake model will be used to compare the efficacy of experimental dentifrice with a marketed dentifrice and placebo dentifrice. Participants wore partial dentures containing two partially demineralized enamel specimens for two weeks- 24 hours per day, except when brushing (twice daily) with test dentifrice. Following each treatment period, the enamel specimens were analyzed for SMH recovery and fluoride uptake through microdrill enamel biopsy technique.
47 studies on the registry are indexed under Tooth Erosion; 7 are open to participants now.
This study's enrollment of 20 is below the median of 33 across 33 interventional studies indexed under Tooth Erosion.
Browse Tooth Erosion studies →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.
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Exclusion Criteria:
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.
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A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants to brush their teeth for one timed minute twice daily with a gel to foam dentifrice containing active ingredients: 1450 ppm F as sodium fluoride (NaF) and 5% potassium nitrate (KNO3) and isopentane as an excipient ingredient.
Drug: NaF/ KNO3/isopentane Dentifrice
Participants to brush their teeth for one timed minute twice daily with a gel to foam dentifrice, containing as active ingredients: 1450 ppm NaF and 5% KNO3 but no isopentane.
Drug: NaF/KNO3 Dentifrice
Participants to brush their teeth for one timed minute twice daily with a dentifrice containing 1450 ppm F as NaF.
Drug: NaF Dentifrice
Participants to brush their teeth for one timed minute twice daily with a fluoride free dentifrice (0 ppm F).
Other: Placebo Dentifrice
Experimental toothpaste
Experimental toothpaste
Active comparator
Placebo comparator
Percentage Surface Micro-hardness Recovery (SMHR) of Enamel Specimens
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 re-hardening of enamel surface. Percent 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
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/cm\^3. The difference between treatments was calculated with respect to fluoride uptake by enamel.
Time frame: Baseline to 14 days
Participants were recruited at the clinical site.
| Milestone | Overall Study |
|---|---|
| Started | 20 |
| Received naf/ kno3/ 2% isopentane | 19 |
| Received naf/kno3/ 0% isopentane | 17 |
| Received naf | 18 |
| Received placebo | 18 |
| Completed | 14 |
| Not completed | 6 |
| Withdrew: Adverse event | 1 |
| Withdrew: Protocol deviation | 2 |
| Withdrew: Could not attend visit 9 | 1 |
| Withdrew: Not capable of wearing partial denture | 1 |
| Withdrew: Cannot continue the study | 1 |
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 re-hardening of enamel surface. Percent 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.
| % SMHR | NaF/ KNO3/ 2% Isopentane Dentifrice | NaF/KNO3/ 0% Isopentane Dentifrice | NaF Dentifrice | Placebo Dentifrice |
|---|---|---|---|---|
| Percentage Surface Micro-hardness Recovery (SMHR) of Enamel Specimens | 39.46 ± 4.10 | 38.31 ± 4.11 | 36.17 ± 4.10 | 17.26 ± 4.04 |
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/cm\^3. The difference between treatments was calculated with respect to fluoride uptake by enamel.
| ug*F/cm^3 | NaF/ KNO3/ 2% Isopentane Dentifrice | NaF/ KNO3/ 0% Isopentane Dentifrice | NaF Dentifrice | Placebo Dentifrice |
|---|---|---|---|---|
| Adjusted Mean Change From Baseline in Enamel Fluoride Uptake | 2445.86 ± 256.55 | 2767.30 ± 257.16 | 2518.54 ± 256.55 | 661.18 ± 252.88 |
Collected over Up to 13 weeks. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| NaF/ KNO3/ 2 % Isopentane Dentifrice | — | 0/17 (0%) | 2/17 (11.8%) |
| NaF/KNO3/ 0% Isopentane Dentifrice | — | 0/17 (0%) | 3/17 (17.6%) |
| NaF Dentifrice | — | 0/18 (0%) | 4/18 (22.2%) |
| Placebo Dentifrice | — | 0/18 (0%) | 2/18 (11.1%) |
| Event | NaF/ KNO3/ 2 % Isopentane Dentifrice | NaF/KNO3/ 0% Isopentane Dentifrice | NaF Dentifrice | Placebo Dentifrice |
|---|---|---|---|---|
| Gingival erythemaGastrointestinal disorders | 0/17 | 1/17 | 2/18 | 0/18 |
| Gingival ulcerationGastrointestinal disorders | 0/17 | 1/17 | 1/18 | 0/18 |
| Localised infectionInfections and infestations | 1/17 | 0/17 | 0/18 | 0/18 |
| NasopharyngitisInfections and infestations | 0/17 | 1/17 | 0/18 | 0/18 |
| Tooth infectionInfections and infestations | 1/17 | 0/17 | 0/18 | 0/18 |
| Food poisoningGastrointestinal disorders | 0/17 | 0/17 | 0/18 | 1/18 |
| Tongue coatedGastrointestinal disorders | 0/17 | 0/17 | 0/18 | 1/18 |
| Tooth fractureInjury, poisoning and procedural complications | 0/17 | 0/17 | 1/18 | 0/18 |
| Age, Continuous(years) | Overall Study Participants |
|---|---|
| Mean | 65.31 ± 8.226 |
| Sex: Female, Male(Participants) | Overall Study Participants |
|---|---|
| Female | 13 |
| Male | 7 |
| Region of Enrollment(participants) | Overall Study Participants |
|---|---|
| United States | 20 |
No study locations are listed for this record.
This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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