Tooth Bleaching
Conditions
Keywords
Toothpastes, Controlled Clinical Trial
Brief summary
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.
Detailed description
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.
Interventions
DRUGToothpaste 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
Use the toothpaste to brush teeth twice a day for 8 weeks
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* Aged between 18-70 years old * Good general health * Could attend the clinical examinations during the 8 week study period * Possessing \>20 natural permanent teeth that were uncrowned or heavily filled with restorative materials, excluding third molars * Having a whole-mouth mean tooth stain score of more than 1.5 according to the Lobene index.
Exclusion criteria
* Severe oral diseases, chronic disease or allergic to the trial products * Advanced periodontal diseases * Females who are pregnant or lactating * Taking part in other clinical trials * Taking part in orthodontic treatment or wearing removable denture * Fluorosis or tetracycline teeth * Receiving prophylaxis during the previous 3 months or tooth whitening treatment during the past 6 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lobene Stain Index of Stain Extent Scores 4 Weeks After Dentifrice Use | 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). |
| Lobene Stain Index of Stain Area Scores 4 Weeks After Dentifrice Use | 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. |
| Lobene Stain Index of Stain Composite Scores 4 Weeks After Dentifrice Use | 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. |
| Lobene Stain Index of Stain Extent Scores 8 Weeks After Dentifrice Use | 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). |
| Lobene Stain Index of Stain Area Scores 8 Weeks After Dentifrice Use | 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. |
| Lobene Stain Index of Stain Composite Scores 8 Weeks After Dentifrice Use | 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. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 40 |
| 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 | 41 |
| Total | 81 |
Baseline characteristics
| Characteristic | Negative Control Toothpaste | Total | Toothpaste Containing Effective Ingredients |
|---|---|---|---|
| Age, Continuous | 42.05 years STANDARD_DEVIATION 10.19 | 42.27 years STANDARD_DEVIATION 9.67 | 42.5 years STANDARD_DEVIATION 9.22 |
| Lobene Stain Index: Area | 1.59 units on a scale STANDARD_DEVIATION 0.45 | 1.61 units on a scale STANDARD_DEVIATION 0.47 | 1.63 units on a scale STANDARD_DEVIATION 0.49 |
| Lobene Stain Index: Composite | 3.72 units on a scale STANDARD_DEVIATION 1.53 | 3.71 units on a scale STANDARD_DEVIATION 1.58 | 3.7 units on a scale STANDARD_DEVIATION 1.65 |
| Lobene Stain Index: Intensity | 1.72 units on a scale STANDARD_DEVIATION 0.59 | 1.7 units on a scale STANDARD_DEVIATION 0.61 | 1.69 units on a scale STANDARD_DEVIATION 0.64 |
| Race/Ethnicity, Customized Han | 41 participants | 81 participants | 40 participants |
| Region of Enrollment China | 41 participants | 81 participants | 40 participants |
| Sex: Female, Male Female | 22 Participants | 39 Participants | 17 Participants |
| Sex: Female, Male Male | 19 Participants | 42 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 41 |
| other Total, other adverse events | 0 / 40 | 0 / 41 |
| serious Total, serious adverse events | 0 / 40 | 0 / 41 |
Outcome results
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.
Time frame: 4 weeks after dentifrice use
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Toothpaste Containing Effective Ingredients | Lobene Stain Index of Stain Area Scores 4 Weeks After Dentifrice Use | 1.1 score on a scale | Standard Deviation 0.44 |
| Negative Control Toothpaste | Lobene Stain Index of Stain Area Scores 4 Weeks After Dentifrice Use | 1.32 score on a scale | Standard Deviation 0.47 |
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.
Time frame: 8 weeks after dentifrice use
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Toothpaste Containing Effective Ingredients | Lobene Stain Index of Stain Area Scores 8 Weeks After Dentifrice Use | 0.83 score on a scale | Standard Deviation 0.36 |
| Negative Control Toothpaste | Lobene Stain Index of Stain Area Scores 8 Weeks After Dentifrice Use | 1.12 score on a scale | Standard Deviation 0.46 |
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.
Time frame: 4 weeks after dentifrice use
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Toothpaste Containing Effective Ingredients | Lobene Stain Index of Stain Composite Scores 4 Weeks After Dentifrice Use | 2.39 score on a scale | Standard Deviation 1.35 |
| Negative Control Toothpaste | Lobene Stain Index of Stain Composite Scores 4 Weeks After Dentifrice Use | 3.23 score on a scale | Standard Deviation 1.6 |
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.
Time frame: 8 weeks after dentifrice use
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Toothpaste Containing Effective Ingredients | Lobene Stain Index of Stain Composite Scores 8 Weeks After Dentifrice Use | 1.45 score on a scale | Standard Deviation 0.78 |
| Negative Control Toothpaste | Lobene Stain Index of Stain Composite Scores 8 Weeks After Dentifrice Use | 2.5 score on a scale | Standard Deviation 1.52 |
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).
Time frame: 4 weeks after dentifrice use
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Toothpaste Containing Effective Ingredients | Lobene Stain Index of Stain Extent Scores 4 Weeks After Dentifrice Use | 1.35 score on a scale | Standard Deviation 0.6 |
| Negative Control Toothpaste | Lobene Stain Index of Stain Extent Scores 4 Weeks After Dentifrice Use | 1.64 score on a scale | Standard Deviation 0.65 |
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).
Time frame: 8 weeks after dentifrice use
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Toothpaste Containing Effective Ingredients | Lobene Stain Index of Stain Extent Scores 8 Weeks After Dentifrice Use | 0.98 score on a scale | Standard Deviation 0.49 |
| Negative Control Toothpaste | Lobene Stain Index of Stain Extent Scores 8 Weeks After Dentifrice Use | 1.33 score on a scale | Standard Deviation 0.68 |