NCT04238429

Whitening Efficacy of Dentifrice Containing 10% High Cleaning Silica, 0.5% Sodium Phytate and 0.5% Sodium Pyrophosphate

Completed NA Results posted Last updated 23 February 2022

What this trial tests

NA trial testing Toothpaste containing 10% high cleaning silica base, 0.5% sodium phytate and 0.5% sodium pyrophosphate in Tooth Bleaching in 86 participants. Completed in 5 October 2018.

Timeline

7 May 2018

Primary endpoint
28 September 2018

5 October 2018

Quick facts

Lead sponsor	Sun Yat-sen University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	86
Start date	7 May 2018
Primary completion	28 September 2018
Estimated completion	5 October 2018
Sites	1 location across China

Drugs / interventions tested

• Toothpaste containing 10% high cleaning silica base, 0.5% sodium phytate and 0.5% sodium pyrophosphate
• Control toothpaste — full drug profile →

Conditions studied

• Tooth Bleaching — all drugs for Tooth Bleaching →

Sponsor

Sun Yat-sen University

Who can join

Adults 18 to 64, any sex, with Tooth Bleaching. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Lobene Stain Index of Stain Extent Scores 4 Weeks After Dentifrice Use Primary · 4 weeks after dentifrice use

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).

Group	Value	95% CI
Toothpaste Containing Effective Ingredients	1.35	± 0.6
Negative Control Toothpaste	1.64	± 0.65

Lobene Stain Index of Stain Area Scores 4 Weeks After Dentifrice Use Primary · 4 weeks after dentifrice use

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 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.

Group	Value	95% CI
Toothpaste Containing Effective Ingredients	1.1	± 0.44
Negative Control Toothpaste	1.32	± 0.47

Lobene Stain Index of Stain Composite Scores 4 Weeks After Dentifrice Use Primary · 4 weeks after dentifrice use

Tooth 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.

Group	Value	95% CI
Toothpaste Containing Effective Ingredients	2.39	± 1.35
Negative Control Toothpaste	3.23	± 1.6

Lobene Stain Index of Stain Extent Scores 8 Weeks After Dentifrice Use Primary · 8 weeks after dentifrice use

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).

Group	Value	95% CI
Toothpaste Containing Effective Ingredients	0.98	± 0.49
Negative Control Toothpaste	1.33	± 0.68

Lobene Stain Index of Stain Area Scores 8 Weeks After Dentifrice Use Primary · 8 weeks after dentifrice use

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 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.

Group	Value	95% CI
Toothpaste Containing Effective Ingredients	0.83	± 0.36
Negative Control Toothpaste	1.12	± 0.46

Lobene Stain Index of Stain Composite Scores 8 Weeks After Dentifrice Use Primary · 8 weeks after dentifrice use

Tooth 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.

Group	Value	95% CI
Toothpaste Containing Effective Ingredients	1.45	± 0.78
Negative Control Toothpaste	2.5	± 1.52

Sponsor's own description

The objective of the present study was to compare the effects of a commercially available dentifrice containing 10% high cleaning silica base, 0.5% sodium phytate and 0.5% sodium pyrophosphate versus a negative control dentifrice on removal of extrinsic stains.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Reduction of extrinsic tooth stain by a toothpaste containing 10% high cleaning silica, 0.5% sodium phytate and 0.5% sodium pyrophosphate: an 8-week randomised clinical trial.
   Liu H, Tu J. · · 2021 · cited 9× · PMID 33706750 · DOI 10.1186/s12903-021-01484-5