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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-07

Study Completion Date

2018-10-05

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Tooth Bleaching

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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

Group Type PLACEBO_COMPARATOR

Control toothpaste

Intervention Type DRUG

Use the toothpaste to brush teeth twice a day for 8 weeks

Interventions

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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

Intervention Type DRUG

Control toothpaste

Use the toothpaste to brush teeth twice a day for 8 weeks

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes