Trial Outcomes & Findings for Whitening Efficacy of Dentifrice Containing 10% High Cleaning Silica, 0.5% Sodium Phytate and 0.5% Sodium Pyrophosphate (NCT NCT04238429)
NCT ID: NCT04238429
Last Updated: 2022-02-23
Results Overview
Tooth stain of the anterior teeth were measured using the Lobene Stain Index. The index measures the area and intensity of extrinsic tooth stain on the facial and lingual surfaces of the lower anterior teeth and facial surfaces of the upper anterior teeth. The tooth surfaces were divided into two parts: body and gingival. For each part, the stain intensity was assessed using 0-3 scale. 0= No stain; 1=Light stain(yellow to light brown or gray); 2=Moderate stain(medium brown); 3=Heavy stain(dark brown to black).
COMPLETED
NA
86 participants
4 weeks after dentifrice use
2022-02-23
Participant Flow
Participant milestones
| Measure |
Toothpaste Containing Effective Ingredients
Use the toothpaste containing 10% high cleaning silica base,0.5% sodium phytate and 0.5% sodium pyrophosphate to brush teeth twice daily for 8 weeks
Toothpaste containing 10% high cleaning silica base, 0.5% sodium phytate and 0.5% sodium pyrophosphate: Use the toothpaste to brush teeth twice a day for 8 weeks
|
Negative Control Toothpaste
Use the negative control dentifrice to brush teeth twice daily for 8 weeks
Control toothpaste: Use the toothpaste to brush teeth twice a day for 8 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
43
|
43
|
|
Overall Study
COMPLETED
|
40
|
41
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Whitening Efficacy of Dentifrice Containing 10% High Cleaning Silica, 0.5% Sodium Phytate and 0.5% Sodium Pyrophosphate
Baseline characteristics by cohort
| Measure |
Toothpaste Containing Effective Ingredients
n=40 Participants
Use the toothpaste containing 10% high cleaning silica base,0.5% sodium phytate and 0.5% sodium pyrophosphate to brush teeth twice daily for 8 weeks
Toothpaste containing 10% high cleaning silica base, 0.5% sodium phytate and 0.5% sodium pyrophosphate: Use the toothpaste to brush teeth twice a day for 8 weeks
|
Negative Control Toothpaste
n=41 Participants
Use the negative control dentifrice to brush teeth twice daily for 8 weeks
Control toothpaste: Use the toothpaste to brush teeth twice a day for 8 weeks
|
Total
n=81 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.5 years
STANDARD_DEVIATION 9.22 • n=5 Participants
|
42.05 years
STANDARD_DEVIATION 10.19 • n=7 Participants
|
42.27 years
STANDARD_DEVIATION 9.67 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Han
|
40 participants
n=5 Participants
|
41 participants
n=7 Participants
|
81 participants
n=5 Participants
|
|
Region of Enrollment
China
|
40 participants
n=5 Participants
|
41 participants
n=7 Participants
|
81 participants
n=5 Participants
|
|
Lobene Stain Index: Area
|
1.63 units on a scale
STANDARD_DEVIATION 0.49 • n=5 Participants
|
1.59 units on a scale
STANDARD_DEVIATION 0.45 • n=7 Participants
|
1.61 units on a scale
STANDARD_DEVIATION 0.47 • n=5 Participants
|
|
Lobene Stain Index: Intensity
|
1.69 units on a scale
STANDARD_DEVIATION 0.64 • n=5 Participants
|
1.72 units on a scale
STANDARD_DEVIATION 0.59 • n=7 Participants
|
1.7 units on a scale
STANDARD_DEVIATION 0.61 • n=5 Participants
|
|
Lobene Stain Index: Composite
|
3.7 units on a scale
STANDARD_DEVIATION 1.65 • n=5 Participants
|
3.72 units on a scale
STANDARD_DEVIATION 1.53 • n=7 Participants
|
3.71 units on a scale
STANDARD_DEVIATION 1.58 • n=5 Participants
|
PRIMARY outcome
Timeframe: 4 weeks after dentifrice useTooth stain of the anterior teeth were measured using the Lobene Stain Index. The index measures the area and intensity of extrinsic tooth stain on the facial and lingual surfaces of the lower anterior teeth and facial surfaces of the upper anterior teeth. The tooth surfaces were divided into two parts: body and gingival. For each part, the stain intensity was assessed using 0-3 scale. 0= No stain; 1=Light stain(yellow to light brown or gray); 2=Moderate stain(medium brown); 3=Heavy stain(dark brown to black).
Outcome measures
| Measure |
Toothpaste Containing Effective Ingredients
n=40 Participants
Use the toothpaste containing 10% high cleaning silica base,0.5% sodium phytate and 0.5% sodium pyrophosphate to brush teeth twice daily for 8 weeks
Toothpaste containing 10% high cleaning silica base, 0.5% sodium phytate and 0.5% sodium pyrophosphate: Use the toothpaste to brush teeth twice a day for 8 weeks
|
Negative Control Toothpaste
n=41 Participants
Use the negative control dentifrice to brush teeth twice daily for 8 weeks
Control toothpaste: Use the toothpaste to brush teeth twice a day for 8 weeks
|
|---|---|---|
|
Lobene Stain Index of Stain Extent Scores 4 Weeks After Dentifrice Use
|
1.35 score on a scale
Standard Deviation 0.6
|
1.64 score on a scale
Standard Deviation 0.65
|
PRIMARY outcome
Timeframe: 4 weeks after dentifrice useTooth stain of the anterior teeth were measured using the Lobene Stain Index. The index measures the area and intensity of extrinsic tooth stain on the facial and lingual surfaces of the lower anterior teeth and facial surfaces of the upper anterior teeth. The tooth surfaces were divided into two parts: body and gingival. For each part, the stain area was assessed using 0-3 scale. 0= No stain detected; 1= stain covering up to 1/3 of the region; 2= Stain covering \>1/3 to 2/3 of the region; 3=Stain covering \>2/3 of the region.
Outcome measures
| Measure |
Toothpaste Containing Effective Ingredients
n=40 Participants
Use the toothpaste containing 10% high cleaning silica base,0.5% sodium phytate and 0.5% sodium pyrophosphate to brush teeth twice daily for 8 weeks
Toothpaste containing 10% high cleaning silica base, 0.5% sodium phytate and 0.5% sodium pyrophosphate: Use the toothpaste to brush teeth twice a day for 8 weeks
|
Negative Control Toothpaste
n=41 Participants
Use the negative control dentifrice to brush teeth twice daily for 8 weeks
Control toothpaste: Use the toothpaste to brush teeth twice a day for 8 weeks
|
|---|---|---|
|
Lobene Stain Index of Stain Area Scores 4 Weeks After Dentifrice Use
|
1.1 score on a scale
Standard Deviation 0.44
|
1.32 score on a scale
Standard Deviation 0.47
|
PRIMARY outcome
Timeframe: 4 weeks after dentifrice useTooth stain of the anterior teeth were measured using the Lobene Stain Index. The tooth surfaces were divided into two parts: body and gingival. For each part, the stain area was assessed using 0-3 scale and the stain intensity was assessed using 0-3 scale. Lobene Stain Index: Composite for each part is the product of the stain area and intensity scores. The minimum score for Lobene Stain Index: Composite is 0 when both the stain area and intensity scores are 0. The maximum score for Lobene Stain Index: Composite is 9 when both the stain area and intensity scores are 3.
Outcome measures
| Measure |
Toothpaste Containing Effective Ingredients
n=40 Participants
Use the toothpaste containing 10% high cleaning silica base,0.5% sodium phytate and 0.5% sodium pyrophosphate to brush teeth twice daily for 8 weeks
Toothpaste containing 10% high cleaning silica base, 0.5% sodium phytate and 0.5% sodium pyrophosphate: Use the toothpaste to brush teeth twice a day for 8 weeks
|
Negative Control Toothpaste
n=41 Participants
Use the negative control dentifrice to brush teeth twice daily for 8 weeks
Control toothpaste: Use the toothpaste to brush teeth twice a day for 8 weeks
|
|---|---|---|
|
Lobene Stain Index of Stain Composite Scores 4 Weeks After Dentifrice Use
|
2.39 score on a scale
Standard Deviation 1.35
|
3.23 score on a scale
Standard Deviation 1.6
|
PRIMARY outcome
Timeframe: 8 weeks after dentifrice useTooth stain of the anterior teeth were measured using the Lobene Stain Index. The index measures the area and intensity of extrinsic tooth stain on the facial and lingual surfaces of the lower anterior teeth and facial surfaces of the upper anterior teeth. The tooth surfaces were divided into two parts: body and gingival. For each part, the stain intensity was assessed using 0-3 scale. 0= No stain; 1=Light stain(yellow to light brown or gray); 2=Moderate stain(medium brown); 3=Heavy stain(dark brown to black).
Outcome measures
| Measure |
Toothpaste Containing Effective Ingredients
n=40 Participants
Use the toothpaste containing 10% high cleaning silica base,0.5% sodium phytate and 0.5% sodium pyrophosphate to brush teeth twice daily for 8 weeks
Toothpaste containing 10% high cleaning silica base, 0.5% sodium phytate and 0.5% sodium pyrophosphate: Use the toothpaste to brush teeth twice a day for 8 weeks
|
Negative Control Toothpaste
n=41 Participants
Use the negative control dentifrice to brush teeth twice daily for 8 weeks
Control toothpaste: Use the toothpaste to brush teeth twice a day for 8 weeks
|
|---|---|---|
|
Lobene Stain Index of Stain Extent Scores 8 Weeks After Dentifrice Use
|
0.98 score on a scale
Standard Deviation 0.49
|
1.33 score on a scale
Standard Deviation 0.68
|
PRIMARY outcome
Timeframe: 8 weeks after dentifrice useTooth stain of the anterior teeth were measured using the Lobene Stain Index. The index measures the area and intensity of extrinsic tooth stain on the facial and lingual surfaces of the lower anterior teeth and facial surfaces of the upper anterior teeth. The tooth surfaces were divided into two parts: body and gingival. For each part, the stain area was assessed using 0-3 scale. 0= No stain detected; 1= stain covering up to 1/3 of the region; 2= Stain covering \>1/3 to 2/3 of the region; 3=Stain covering \>2/3 of the region.
Outcome measures
| Measure |
Toothpaste Containing Effective Ingredients
n=40 Participants
Use the toothpaste containing 10% high cleaning silica base,0.5% sodium phytate and 0.5% sodium pyrophosphate to brush teeth twice daily for 8 weeks
Toothpaste containing 10% high cleaning silica base, 0.5% sodium phytate and 0.5% sodium pyrophosphate: Use the toothpaste to brush teeth twice a day for 8 weeks
|
Negative Control Toothpaste
n=41 Participants
Use the negative control dentifrice to brush teeth twice daily for 8 weeks
Control toothpaste: Use the toothpaste to brush teeth twice a day for 8 weeks
|
|---|---|---|
|
Lobene Stain Index of Stain Area Scores 8 Weeks After Dentifrice Use
|
0.83 score on a scale
Standard Deviation 0.36
|
1.12 score on a scale
Standard Deviation 0.46
|
PRIMARY outcome
Timeframe: 8 weeks after dentifrice useTooth stain of the anterior teeth were measured using the Lobene Stain Index. The tooth surfaces were divided into two parts: body and gingival. For each part, the stain area was assessed using 0-3 scale and the stain intensity was assessed using 0-3 scale. Lobene Stain Index: Composite for each part is the product of the stain area and intensity scores. The minimum score for Lobene Stain Index: Composite is 0 when both the stain area and intensity scores are 0. The maximum score for Lobene Stain Index: Composite is 9 when both the stain area and intensity scores are 3.
Outcome measures
| Measure |
Toothpaste Containing Effective Ingredients
n=40 Participants
Use the toothpaste containing 10% high cleaning silica base,0.5% sodium phytate and 0.5% sodium pyrophosphate to brush teeth twice daily for 8 weeks
Toothpaste containing 10% high cleaning silica base, 0.5% sodium phytate and 0.5% sodium pyrophosphate: Use the toothpaste to brush teeth twice a day for 8 weeks
|
Negative Control Toothpaste
n=41 Participants
Use the negative control dentifrice to brush teeth twice daily for 8 weeks
Control toothpaste: Use the toothpaste to brush teeth twice a day for 8 weeks
|
|---|---|---|
|
Lobene Stain Index of Stain Composite Scores 8 Weeks After Dentifrice Use
|
1.45 score on a scale
Standard Deviation 0.78
|
2.5 score on a scale
Standard Deviation 1.52
|
Adverse Events
Toothpaste Containing Effective Ingredients
Negative Control Toothpaste
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place