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

Sun Yat-sen University

Status: Completed

Conditions: Tooth Bleaching

Treatments: Drug: Control toothpaste; Drug: Toothpaste containing 10% high cleaning silica base, 0.5% sodium phytate and 0.5% sodium pyrophosphate

Study type: Interventional

Funder types: Other

Identifiers

NCT04238429

Toothpaste whitenning

Details and patient eligibility

About

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.

Full 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.

Enrollment: 86 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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86 participants in 2 patient groups, including a placebo group

Toothpaste containing effective ingredients

Experimental group

Description:

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

Treatment:

Drug: Toothpaste containing 10% high cleaning silica base, 0.5% sodium phytate and 0.5% sodium pyrophosphate

Negative control toothpaste

Placebo Comparator group

Description:

Use the negative control dentifrice to brush teeth twice daily for 8 weeks

Treatment:

Drug: Control toothpaste