Trial Outcomes & Findings for Evaluation of Efficacy of Experimental Gel to Foam Dentifrices in Dental Erosion (NCT NCT01657903)
NCT ID: NCT01657903
Last Updated: 2015-01-26
Results Overview
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.
COMPLETED
NA
56 participants
Baseline, 4 hours post treatment in each treatment period
2015-01-26
Participant Flow
Participants were recruited at the clinical site.
Participant milestones
| Measure |
Overall
This was a 4-way crossover study. Participants brushed with 1.5 g of low relative dentine abrasivity (RDA) gel to foam toothpaste (Toothpaste 1) containing 1450 parts per million (ppm) of fluoride (F) as sodium fluoride (NaF) and 5% weight by weight (w/w) potassium nitrate (KNO3); 1.5 g of medium RDA gel to foam toothpaste (Toothpaste 2) containing 1450 ppm F as NaF and 5% w/w KNO3; 1.5 g of Marketed toothpaste (Toothpaste 3) containing 1450 ppm F as NaF and 5% w/w KNO3; and 1.5 g of placebo toothpaste containing no fluoride but 5% w/w KNO3. There was a washout period of 2 days following each treatment session. In this washout period, participants used a non-fluoridated toothpaste to ensure no carry over effect.
|
|---|---|
|
Overall Study
STARTED
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56
|
|
Overall Study
Received Placebo (No NaF/KNO3)Toothpaste
|
56
|
|
Overall Study
Received NaF/KNO3 Toothpaste 1
|
55
|
|
Overall Study
Received NaF/KNO3 Toothpaste 3
|
54
|
|
Overall Study
Received NaF/KNO3 Toothpaste 2
|
55
|
|
Overall Study
COMPLETED
|
54
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Overall
This was a 4-way crossover study. Participants brushed with 1.5 g of low relative dentine abrasivity (RDA) gel to foam toothpaste (Toothpaste 1) containing 1450 parts per million (ppm) of fluoride (F) as sodium fluoride (NaF) and 5% weight by weight (w/w) potassium nitrate (KNO3); 1.5 g of medium RDA gel to foam toothpaste (Toothpaste 2) containing 1450 ppm F as NaF and 5% w/w KNO3; 1.5 g of Marketed toothpaste (Toothpaste 3) containing 1450 ppm F as NaF and 5% w/w KNO3; and 1.5 g of placebo toothpaste containing no fluoride but 5% w/w KNO3. There was a washout period of 2 days following each treatment session. In this washout period, participants used a non-fluoridated toothpaste to ensure no carry over effect.
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|---|---|
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Overall Study
Lost to Follow-up
|
1
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|
Overall Study
Withdrawal by Subject
|
1
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Baseline Characteristics
Evaluation of Efficacy of Experimental Gel to Foam Dentifrices in Dental Erosion
Baseline characteristics by cohort
| Measure |
All Randomized Participants
n=56 Participants
All randomized participants were evaluated for baseline parameters.
|
|---|---|
|
Age, Continuous
|
38.7 Years
STANDARD_DEVIATION 13.77 • n=39 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: Baseline, 4 hours post treatment in each treatment periodPopulation: Per protocol (PP) population: All randomized subjects who had at least one assessment of efficacy and considered unaffected by major protocol deviations, were included in analysis. Due to drop outs, there was difference in number of participants analyzed.
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.
Outcome measures
| Measure |
NaF/KNO3 Toothpaste 1
n=55 Participants
Participants brushed with 1.5 g of low RDA gel to foam toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
|
NaF/KNO3 Toothpaste 2
n=54 Participants
Participants brushed with 1.5 g of medium RDA gel to foam toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
|
NaF/KNO3 Toothpaste 3
n=54 Participants
Participants brushed with 1.5 g of NaF/KNO3 toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
|
No Fluoride/KNO3 Toothpaste
n=56 Participants
Participants brushed with a fluoride free toothpaste (0 ppmF) containing only 5% w/w KNO3.
|
|---|---|---|---|---|
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Relative Erosion Resistance (RER) of Enamel Specimens Post 4 Hours of Treatment Exposure
|
-36.66 Percentage RER
Standard Error 2.824
|
-36.53 Percentage RER
Standard Error 2.848
|
-36.98 Percentage RER
Standard Error 2.847
|
-77.82 Percentage RER
Standard Error 2.799
|
PRIMARY outcome
Timeframe: Baseline, 4 hours post treatment in each treatment periodPopulation: PP population: All randomized subjects who had at least one assessment of efficacy and considered unaffected by major protocol deviations, were included in analysis. Due to drop outs, there was difference in number of participants analyzed.
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.
Outcome measures
| Measure |
NaF/KNO3 Toothpaste 1
n=55 Participants
Participants brushed with 1.5 g of low RDA gel to foam toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
|
NaF/KNO3 Toothpaste 2
n=54 Participants
Participants brushed with 1.5 g of medium RDA gel to foam toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
|
NaF/KNO3 Toothpaste 3
n=54 Participants
Participants brushed with 1.5 g of NaF/KNO3 toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
|
No Fluoride/KNO3 Toothpaste
n=56 Participants
Participants brushed with a fluoride free toothpaste (0 ppmF) containing only 5% w/w KNO3.
|
|---|---|---|---|---|
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Surface Microhardness (SMH) Recovery of Enamel Specimens Post 4 Hours of Treatment Exposure
|
32.24 Percentage SMH
Standard Error 1.469
|
32.32 Percentage SMH
Standard Error 1.480
|
34.53 Percentage SMH
Standard Error 1.480
|
22.87 Percentage SMH
Standard Error 1.457
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 2 hours post treatment in each treatment periodPopulation: PP population: All randomized subjects who had at least one assessment of efficacy and considered unaffected by major protocol deviations, were included in analysis. Due to drop outs, there was difference in number of participants analyzed.
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.
Outcome measures
| Measure |
NaF/KNO3 Toothpaste 1
n=55 Participants
Participants brushed with 1.5 g of low RDA gel to foam toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
|
NaF/KNO3 Toothpaste 2
n=54 Participants
Participants brushed with 1.5 g of medium RDA gel to foam toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
|
NaF/KNO3 Toothpaste 3
n=54 Participants
Participants brushed with 1.5 g of NaF/KNO3 toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
|
No Fluoride/KNO3 Toothpaste
n=56 Participants
Participants brushed with a fluoride free toothpaste (0 ppmF) containing only 5% w/w KNO3.
|
|---|---|---|---|---|
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RER of Enamel Specimens Post 2 Hours of Treatment Exposure
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-43.76 % RER
Standard Error 3.182
|
-43.33 % RER
Standard Error 3.211
|
-41.88 % RER
Standard Error 3.210
|
-85.88 % RER
Standard Error 3.154
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 2 hours post treatment in each treatment periodPopulation: PP population: All randomized subjects who had at least one assessment of efficacy and considered unaffected by major protocol deviations, were included in analysis.
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.
Outcome measures
| Measure |
NaF/KNO3 Toothpaste 1
n=55 Participants
Participants brushed with 1.5 g of low RDA gel to foam toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
|
NaF/KNO3 Toothpaste 2
n=54 Participants
Participants brushed with 1.5 g of medium RDA gel to foam toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
|
NaF/KNO3 Toothpaste 3
n=54 Participants
Participants brushed with 1.5 g of NaF/KNO3 toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
|
No Fluoride/KNO3 Toothpaste
n=56 Participants
Participants brushed with a fluoride free toothpaste (0 ppmF) containing only 5% w/w KNO3.
|
|---|---|---|---|---|
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SMH Recovery of Enamel Specimens Post 2 Hours of Treatment Exposure
|
28.96 Percentage SMH
Standard Error 1.600
|
28.92 Percentage SMH
Standard Error 1.615
|
28.30 Percentage SMH
Standard Error 1.615
|
17.90 Percentage SMH
Standard Error 1.585
|
Adverse Events
NaF/KNO3 Toothpaste 1
NaF/KNO3 Toothpaste 2
NaF/KNO3 Toothpaste 3
No Fluoride/KNO3 Toothpaste
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
NaF/KNO3 Toothpaste 1
n=55 participants at risk
Participants brushed with 1.5 g of low RDA gel to foam toothpaste containing 1450 parts per million of fluoride as NaF and 5% w/w KNO3.
|
NaF/KNO3 Toothpaste 2
n=55 participants at risk
Participants brushed with 1.5 g of medium RDA gel to foam toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
|
NaF/KNO3 Toothpaste 3
n=54 participants at risk
Participants brushed with 1.5 g of NaF/KNO3 toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
|
No Fluoride/KNO3 Toothpaste
n=56 participants at risk
Participants brushed with a fluoride free toothpaste (0 ppmF) containing only 5% w/w KNO3.
|
|---|---|---|---|---|
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Gastrointestinal disorders
Gingival Pain
|
1.8%
1/55 • Number of events 1 • 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.
|
0.00%
0/55 • 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.
|
0.00%
0/54 • 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.
|
0.00%
0/56 • 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.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/55 • 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.
|
0.00%
0/55 • 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.
|
1.9%
1/54 • Number of events 1 • 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.
|
3.6%
2/56 • Number of events 2 • 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.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
1.8%
1/55 • Number of events 1 • 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.
|
0.00%
0/55 • 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.
|
0.00%
0/54 • 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.
|
0.00%
0/56 • 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.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER