An interventional study of Sodium Fluoride and Potassium nitrate in Dental Erosion and Acid Wear, 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 2015-01-26.
Sponsored by GlaxoSmithKline · Not applicable, Interventional, and Treatment
The purpose of this study is to compare and evaluate the ability of two European Union (EU) regulated gel to foam toothpaste formulations versus a non-fluoride toothpaste using a modified in-situ model of dental erosion and remineralization. A positive control i.e fluoride containing toothpaste marketed in EU will also be compared to non-fluoride toothpaste.
The aim of this study is to assess the remineralization effects of two EU gel to foam toothpaste formulations with 1450 parts per million (ppm) of fluoride as sodium fluoride (NaF) and 5% potassium nitrate (KNO3) versus a non-fluoride (0 ppm F)/KNO3 toothpaste as a negative control. The two experimental gel to foam toothpaste formulations differ in their relative dentine abrasivity (RDA) values which is an in-vitro measure of a toothpaste abrasivity to the dentinal tissues. A marketed toothpaste containing NaF and KNO3 will serve as a positive control.
47 studies on the registry are indexed under Tooth Erosion; 7 are open to participants now.
This study's enrollment of 56 is above 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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Oral Requirements:
Exclusion Criteria:
Oral Health:
Clinical Study/Experimental Medication:
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.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
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.
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.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
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.
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 with 1.5 g of low RDA gel to foam toothpaste containing 1450 ppm F - EU level as NaF. All study treatments contain 5% weight by weight (w/w) KNO3.
Drug: Sodium Fluoride · Drug: Potassium nitrate
Participants to brush with 1.5 g of medium RDA gel to foam toothpaste containing 1450 ppm F - EU level as NaF. All study treatments contain 5% w/w KNO3.
Drug: Sodium Fluoride · Drug: Potassium nitrate
Participants to brush with 1.5 g of NaF/KNO3 toothpaste containing 1450 ppm F - EU level as NaF. All study treatments contain 5% w/w KNO3.
Drug: Sodium Fluoride · Drug: Potassium nitrate
Participants to brush with a fluoride free toothpaste (0 ppmF). All study treatments contain 5% w/w KNO3.
Drug: Potassium nitrate
Toothpaste containing 1450 ppm F - EU level as NaF.
All study treatments contain 5% w/w KNO3.
Relative Erosion Resistance (RER) of Enamel Specimens Post 4 Hours of Treatment Exposure
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 RER which compared the indentations values of enamel specimens at baseline (B), first erosive (E1) and second erosive challenge (E2). Percent RER was calculated by formula: \[(E1-E2)/ (E1-B)\]\*100. Smaller the negative RER, better is treatment regimen in imparting resistance to enamel.
Time frame: Baseline, 4 hours post treatment in each treatment period
Surface Microhardness (SMH) Recovery of Enamel Specimens Post 4 Hours of Treatment Exposure
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. A higher percentage values indicate a better outcome.
Time frame: Baseline, 4 hours post treatment in each treatment period
RER of Enamel Specimens Post 2 Hours of Treatment Exposure
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 RER which compared the indentations values of enamel specimens at baseline (B), first erosive (E1) and second erosive challenge (E2). Percent RER was calculated by formula: \[(E1-E2)/ (E1-B)\]\*100. Smaller the negative RER, better is treatment regimen in imparting resistance to enamel.
Time frame: Baseline, 2 hours post treatment in each treatment period
SMH Recovery of Enamel Specimens Post 2 Hours of Treatment Exposure
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. A higher percentage values indicate a better outcome.
Time frame: Baseline, 2 hours post treatment in each treatment period
Participants were recruited at the clinical site.
| Milestone | Overall |
|---|---|
| Started | 56 |
| Received placebo (no naf/kno3)toothpaste | 56 |
| Received naf/kno3 toothpaste 1 | 55 |
| Received naf/kno3 toothpaste 3 | 54 |
| Received naf/kno3 toothpaste 2 | 55 |
| Completed | 54 |
| Not completed | 2 |
| Withdrew: Lost to follow-up | 1 |
| Withdrew: Withdrawal by subject | 1 |
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 RER which compared the indentations values of enamel specimens at baseline (B), first erosive (E1) and second erosive challenge (E2). Percent RER was calculated by formula: \[(E1-E2)/ (E1-B)\]\*100. Smaller the negative RER, better is treatment regimen in imparting resistance to enamel.
| Percentage RER | NaF/KNO3 Toothpaste 1 | NaF/KNO3 Toothpaste 2 | NaF/KNO3 Toothpaste 3 | No Fluoride/KNO3 Toothpaste |
|---|---|---|---|---|
| Relative Erosion Resistance (RER) of Enamel Specimens Post 4 Hours of Treatment Exposure | -36.66 ± 2.824 | -36.53 ± 2.848 | -36.98 ± 2.847 | -77.82 ± 2.799 |
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. A higher percentage values indicate a better outcome.
| Percentage SMH | NaF/KNO3 Toothpaste 1 | NaF/KNO3 Toothpaste 2 | NaF/KNO3 Toothpaste 3 | No Fluoride/KNO3 Toothpaste |
|---|---|---|---|---|
| Surface Microhardness (SMH) Recovery of Enamel Specimens Post 4 Hours of Treatment Exposure | 32.24 ± 1.469 | 32.32 ± 1.480 | 34.53 ± 1.480 | 22.87 ± 1.457 |
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 RER which compared the indentations values of enamel specimens at baseline (B), first erosive (E1) and second erosive challenge (E2). Percent RER was calculated by formula: \[(E1-E2)/ (E1-B)\]\*100. Smaller the negative RER, better is treatment regimen in imparting resistance to enamel.
| % RER | NaF/KNO3 Toothpaste 1 | NaF/KNO3 Toothpaste 2 | NaF/KNO3 Toothpaste 3 | No Fluoride/KNO3 Toothpaste |
|---|---|---|---|---|
| RER of Enamel Specimens Post 2 Hours of Treatment Exposure | -43.76 ± 3.182 | -43.33 ± 3.211 | -41.88 ± 3.210 | -85.88 ± 3.154 |
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. A higher percentage values indicate a better outcome.
| Percentage SMH | NaF/KNO3 Toothpaste 1 | NaF/KNO3 Toothpaste 2 | NaF/KNO3 Toothpaste 3 | No Fluoride/KNO3 Toothpaste |
|---|---|---|---|---|
| SMH Recovery of Enamel Specimens Post 2 Hours of Treatment Exposure | 28.96 ± 1.600 | 28.92 ± 1.615 | 28.30 ± 1.615 | 17.90 ± 1.585 |
Collected over All adverse events 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 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| NaF/KNO3 Toothpaste 1 | — | 0/55 (0%) | 2/55 (3.6%) |
| NaF/KNO3 Toothpaste 2 | — | 0/55 (0%) | 0/55 (0%) |
| NaF/KNO3 Toothpaste 3 | — | 0/54 (0%) | 1/54 (1.9%) |
| No Fluoride/KNO3 Toothpaste | — | 0/56 (0%) | 2/56 (3.6%) |
| Event | NaF/KNO3 Toothpaste 1 | NaF/KNO3 Toothpaste 2 | NaF/KNO3 Toothpaste 3 | No Fluoride/KNO3 Toothpaste |
|---|---|---|---|---|
| NasopharyngitisInfections and infestations | 0/55 | 0/55 | 1/54 | 2/56 |
| Gingival PainGastrointestinal disorders | 1/55 | 0/55 | 0/54 | 0/56 |
| Back PainMusculoskeletal and connective tissue disorders | 1/55 | 0/55 | 0/54 | 0/56 |
| Age, Continuous(Years) | All Randomized Participants |
|---|---|
| Mean | 38.7 ± 13.77 |
| Sex: Female, Male(Participants) | All Randomized Participants |
|---|---|
| Female | 27 |
| Male | 29 |
This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Sodium Fluoride