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

NCT04238429 | Completed Results

• 1 other identifier: Toothpaste whitenning
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Tooth Bleaching

Keywords

Toothpastes; Controlled Clinical Trial

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

Toothpaste containing effective ingredients

EXPERIMENTAL

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

Negative control toothpaste

PLACEBO COMPARATOR

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

Drug: Control toothpaste

Interventions

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

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

Toothpaste containing effective ingredients

Control toothpaste DRUG

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

Negative control toothpaste

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Guanghua School of Stomatology

Guangzhou, Guangdong, 510055, China

Location

Related Publications (1)

• 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.

  PMID: 33706750 DERIVED

MeSH Terms

Interventions

Phytic Acid; sodium pyrophosphate

Intervention Hierarchy (Ancestors)

Inositol Phosphates; Inositol; Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates; Sugar Phosphates

Results Point of Contact

• Title: Dr. Hongchun Liu
• Organization: Sun Yat-sen University

hongchun_liu@vip.sina.com

86-13826189071

Study Officials

• Hongchun Liu, Ph.D.

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 18, 2020
• First Posted: January 23, 2020
• Study Start: May 7, 2018
• Primary Completion: September 28, 2018
• Study Completion: October 5, 2018
• Last Updated: February 23, 2022
• Results First Posted: May 18, 2020

Record last verified: 2022-02

Locations

CN (1)