Trial Outcomes & Findings for In Situ Erosion Study to Investigate the Effectiveness of an Experimental Toothpaste (NCT NCT03296072)

Last Updated: 2020-09-16

Results Overview

The %SMHR was calculated to assess the changes in mineralization status of enamel specimens. The mean indent length (micrometer) from five Knoop microindentations within each specimen was measured at baseline (B), after the first erosive challenge (E1), and after 2 and 4 hours intraoral phase (R). An increase in the indentation length compared to the baseline indicates softening of the enamel surface while decrease in the indentation length represents re-hardening of enamel surface. The %SMHR was calculated as : %SMHR = \[(E1-R)/(E1-B)\]\*100. Greater values of %SMHR indicate that greater remineralization has occurred, thus higher values are more favorable.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

62 participants

Primary outcome timeframe

After 4 hrs following single exposure of treatment

Results posted on

2020-09-16

Participant Flow

Participants were recruited from one center in United States of America.

A total of 68 participates were screened, out of which 62 participants were randomized in the study and 6 participants were not randomized as all the 6 participants did not meet study criteria.

Participant milestones

Participant milestones
Measure	Test Product/Comparator Product/Placebo Product Participants in this arm received test product (0.254% weight by weight \[w/w\] sodium fluoride \[NaF; 1150 parts per million {ppm} fluoride\] and 5% potassium nitrate \[KNO3\]) followed by comparator (0.454% w/w stannous fluoride \[SnF2; 1100 ppm fluoride\]) and placebo product (5% KNO3 \[0 ppm fluoride\]) in Period 1, 2 and 3 respectively. Each treatment period was separated by a wash out period of minimum 3 days (including 2 day washout period using a non-fluoride toothpaste). Participants applied a full ribbon (1.5 grams \[g\]) of the allocated product and brushed the buccal surfaces of their natural teeth for 25 timed seconds and then swished the resulting toothpaste slurry around the mouth, without further brushing,for a timed period of 95 seconds. After expectorating the slurry, participants gently rinsed their mouths with 15 milliliters \[mL\] of tap water for 10 seconds before expectorating again.	Test Product/Placebo Product/Comparator Product Participants in this arm received test product (0.254% w/w NaF \[1150 ppm fluoride\] and 5% KNO3) followed by placebo (5% KNO3 \[0 ppm fluoride\])and comparator product (0.454% w/w SnF2\[1100 ppm fluoride\]) in Period 1, 2 and 3 respectively. Each treatment period was separated by a wash out period of minimum 3 days (including 2 day washout period using a non-fluoride toothpaste). Participants applied a full ribbon (1.5 g) of the allocated product and brushed the buccal surfaces of their natural teeth for 25 timed seconds and then swished the resulting toothpaste slurry around the mouth, without further brushing, for a timed period of 95 seconds. After expectorating the slurry, the participants gently rinsed their mouths with 15 mL of tap water for 10 seconds before expectorating again.	Comparator Product/Test Product/Placebo Product Participants in this arm received comparator product (0.454% w/w SnF2\[1100 ppm fluoride\]) followed by test (0.254% w/w NaF \[1150 ppm fluoride\] and 5% KNO3) and placebo product(5% KNO3 \[0 ppm fluoride\]) in Period 1, 2 and 3 respectively. Each treatment period was separated by a wash out period of minimum 3 days (including 2 day washout period using a non-fluoride toothpaste). Participants applied a full ribbon (1.5 g) of the allocated product and brushed the buccal surfaces of their natural teeth for 25 timed seconds and then swished the resulting toothpaste slurry around the mouth, without further brushing, for a timed period of 95 seconds. After expectorating the slurry, the participants gently rinsed their mouths with 15 mL of tap water for 10 seconds before expectorating again.	Comparator Product/Placebo Product/ Test Product Participants in this arm received comparator product (0.454% w/w SnF2\[1100 ppm fluoride\]) followed by placebo (5% KNO3 \[0 ppm fluoride\])and test product (0.254% w/w NaF \[1150 ppm fluoride\] and 5% KNO3) in Period 1, 2 and 3 respectively. Each treatment period was separated by a wash out period of minimum 3 days (including 2 day washout period using a non-fluoride toothpaste). Participants applied a full ribbon (1.5 g) of the allocated product and brushed the buccal surfaces of their natural teeth for 25 timed seconds and then swished the resulting toothpaste slurry around the mouth, without further brushing, for a timed period of 95 seconds. After expectorating the slurry, the participants gently rinsed their mouths with 15 mL of tap water for 10 seconds before expectorating again.	Placebo Product/Test Product/Comparator Product Participants in this arm received placebo product (5% KNO3 \[0 ppm fluoride\]) followed by test (0.254% w/w NaF \[1150 ppm fluoride\] and 5% KNO3) and comparator product (0.454% w/w SnF2 \[1100 ppm fluoride\]) in Period 1, 2 and 3 respectively. Each treatment period was separated by a wash out period of minimum 3 days (including 2 day washout period using a non-fluoride toothpaste). Participants applied a full ribbon (1.5 g) of the allocated product and brushed the buccal surfaces of their natural teeth for 25 timed seconds and then swished the resulting toothpaste slurry around the mouth, without further brushing, for a timed period of 95 seconds. After expectorating the slurry, the participants gently rinsed their mouths with 15 mL of tap water for 10 seconds before expectorating again.	Placebo Product/Comparator Product/Test Product Participants in this arm received placebo product (5% KNO3 \[0 ppm fluoride\]) followed by comparator (0.454% w/w SnF2\[1100 ppm fluoride\]) and test product (0.254% w/w NaF \[1150 ppm fluoride\] and 5% KNO3) in Period 1, 2 and 3 respectively. Each treatment period was separated by a wash out period of minimum 3 days (including 2 day washout period using a non-fluoride toothpaste). Participants applied a full ribbon (1.5 g) of the allocated product and brushed the buccal surfaces of their natural teeth for 25 timed seconds and then swished the resulting toothpaste slurry around the mouth, without further brushing, for a timed period of 95 seconds. After expectorating the slurry, the participants gently rinsed their mouths with 15 mL of tap water for 10 seconds before expectorating again.
Treatment Period 1 STARTED	10	11	10	10	10	11
Treatment Period 1 COMPLETED	10	11	10	10	10	11
Treatment Period 1 NOT COMPLETED	0	0	0	0	0	0
Treament Period 1: Wash Out Period STARTED	10	11	10	10	10	11
Treament Period 1: Wash Out Period COMPLETED	10	11	10	10	10	11
Treament Period 1: Wash Out Period NOT COMPLETED	0	0	0	0	0	0
Treament Period 2 STARTED	10	11	10	10	10	11
Treament Period 2 COMPLETED	10	11	10	10	10	11
Treament Period 2 NOT COMPLETED	0	0	0	0	0	0
Treament Period 2: Wash Out Period STARTED	10	11	10	10	10	11
Treament Period 2: Wash Out Period COMPLETED	10	11	10	10	10	11
Treament Period 2: Wash Out Period NOT COMPLETED	0	0	0	0	0	0
Treament Period 3 STARTED	10	11	10	10	10	11
Treament Period 3 COMPLETED	10	11	10	10	10	11
Treament Period 3 NOT COMPLETED	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

In Situ Erosion Study to Investigate the Effectiveness of an Experimental Toothpaste