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

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

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.

Study Overview

• Status: Completed
• Conditions: Tooth Bleaching
• Intervention / Treatment: Drug: Toothpaste containing 10% high cleaning silica base, 0.5% sodium phytate and 0.5% sodium pyrophosphate; Drug: Control toothpaste

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.

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510055
      • Guanghua School of Stomatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: 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
Placebo Comparator: Negative control toothpaste; Use the negative control dentifrice to brush teeth twice daily for 8 weeks	Drug: Control toothpaste; Use the toothpaste to brush teeth twice a day for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Investigators: Principal Investigator: Hongchun Liu, Ph.D., Sun Yat-sen University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2018
• Primary Completion (Actual): September 28, 2018
• Study Completion (Actual): October 5, 2018

Study Registration Dates

• First Submitted: January 18, 2020
• First Submitted That Met QC Criteria: January 22, 2020
• First Posted (Actual): January 23, 2020

Study Record Updates

• Last Update Posted (Actual): February 23, 2022
• Last Update Submitted That Met QC Criteria: February 21, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Controlled Clinical Trial; Toothpastes
• Other Study ID Numbers: Toothpaste whitenning

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No