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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.
There is great concern on the tooth esthetics and color among people, especially young adults. Great efforts have been made in order to improve patients' smile. Epidemiological studies have reported that dissatisfaction with tooth color ranged from 19.6% to 65.9%, depending on different population. An oral health related quality of life questionnaire for use among young adults reported that tooth color was the most important concern. This dissatisfaction with tooth color has been shown to be associated with increased desire for treatments that improve dental aesthetics including tooth whitening dentifrices. Tooth whitening products generally help to improve the overall whiteness of teeth, by removing and controlling the formation of extrinsic stains. In recent years the interest on the treatment of tooth stain with various tooth whitening agents, among which dentifrice containing high cleaning silica is widely used.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Toothpaste containing effective ingredients | Experimental | 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 |
|
| Negative control toothpaste | Placebo Comparator | Use the negative control dentifrice to brush teeth twice daily for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Toothpaste containing 10% high cleaning silica base, 0.5% sodium phytate and 0.5% sodium pyrophosphate | Drug | Use the toothpaste to brush teeth twice a day for 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lobene Stain Index of Stain Extent Scores 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). | 4 weeks after dentifrice use |
| Lobene Stain Index of Stain Area Scores 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. | 4 weeks after dentifrice use |
| Lobene Stain Index of Stain Composite Scores 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. | 4 weeks after dentifrice use |
| Lobene Stain Index of Stain Extent Scores 8 Weeks After Dentifrice Use |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hongchun Liu, Ph.D. | Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guanghua School of Stomatology | Guangzhou | Guangdong | 510055 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33706750 | Derived | Liu H, Tu J. 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. BMC Oral Health. 2021 Mar 11;21(1):113. doi: 10.1186/s12903-021-01484-5. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 2, 2018 |
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| Control toothpaste | Drug | Use the toothpaste to brush teeth twice a day for 8 weeks |
|
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).
| 8 weeks after dentifrice use |
| Lobene Stain Index of Stain Area Scores 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. | 8 weeks after dentifrice use |
| Lobene Stain Index of Stain Composite Scores 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. | 8 weeks after dentifrice use |
| FG001 |
| 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 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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| Lobene Stain Index: Area | 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. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Lobene Stain Index: Intensity | 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). | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Lobene Stain Index: Composite | 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. | Mean | Standard Deviation | units on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Lobene Stain Index of Stain Extent Scores 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). | Posted | Mean | Standard Deviation | score on a scale | 4 weeks after dentifrice use |
|
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| Primary | Lobene Stain Index of Stain Area Scores 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. | Posted | Mean | Standard Deviation | score on a scale | 4 weeks after dentifrice use |
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| Primary | Lobene Stain Index of Stain Composite Scores 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. | Posted | Mean | Standard Deviation | score on a scale | 4 weeks after dentifrice use |
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| Primary | Lobene Stain Index of Stain Extent Scores 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). | Posted | Mean | Standard Deviation | score on a scale | 8 weeks after dentifrice use |
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| Primary | Lobene Stain Index of Stain Area Scores 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. | Posted | Mean | Standard Deviation | score on a scale | 8 weeks after dentifrice use |
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| Primary | Lobene Stain Index of Stain Composite Scores 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. | Posted | Mean | Standard Deviation | score on a scale | 8 weeks after dentifrice use |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 40 | 0 | 40 | 0 | 40 |
| EG001 | 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 | 0 | 41 | 0 | 41 | 0 | 41 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Hongchun Liu | Sun Yat-sen University | 86-13826189071 | hongchun_liu@vip.sina.com |
| May 17, 2020 |
| Prot_SAP_001.pdf |
| ID | Term |
|---|---|
| D010833 | Phytic Acid |
| C003319 | sodium pyrophosphate |
| ID | Term |
|---|---|
| D007295 | Inositol Phosphates |
| D007294 | Inositol |
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D002241 | Carbohydrates |
| D013403 | Sugar Phosphates |
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