Clinical trial NCT04238429: Whitening Efficacy of Dentifrice Containing 10% High Cleaning Silica, 0.5% Sodium Phytate and 0.5% Sodium Pyrophosphate
Official title: Efficacy of a Commercial Dentifrice Containing 10% High Cleaning Silica Base, 0.5% Sodium Phytate and 0.5% Sodium Pyrophosphate on Tooth Whitening: A 8-week Clinical Study in Adults in China
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Bleaching
Keywords: Toothpastes
Controlled Clinical Trial
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2020-01-23
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Lobene Stain Index of Stain Extent Scores 4 Weeks After Dentifrice Use
timeFrame: 4 weeks after dentifrice use
measure: Lobene Stain Index of Stain Area Scores 4 Weeks After Dentifrice Use
timeFrame: 4 weeks after dentifrice use
measure: Lobene Stain Index of Stain Composite Scores 4 Weeks After Dentifrice Use
timeFrame: 4 weeks after dentifrice use
measure: Lobene Stain Index of Stain Extent Scores 8 Weeks After Dentifrice Use
timeFrame: 8 weeks after dentifrice use
measure: Lobene Stain Index of Stain Area Scores 8 Weeks After Dentifrice Use
timeFrame: 8 weeks after dentifrice use
measure: Lobene Stain Index of Stain Composite Scores 8 Weeks After Dentifrice Use
timeFrame: 8 weeks after dentifrice use
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guanghua School of Stomatology
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Hongchun Liu, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.