N/A
N=86
Whitening Efficacy of Dentifrice Containing 10% High Cleaning Silica, 0.5% Sodium Phytate and 0.5% Sodium Pyrophosphate
Tooth Bleaching
Bottom Line
View on ClinicalTrials.gov: NCT04238429 ↗Enrolled (actual)
86
Serious AEs
0.0%
Results posted
May 2020
Primary outcome: Primary: Lobene Stain Index of Stain Extent Scores 4 Weeks After Dentifrice Use — 1.35; 1.64 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Toothpaste containing 10% high cleaning silica base, 0.5% sodium phytate and 0.5% sodium pyrophosphate (Drug); Control toothpaste (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sun Yat-sen University
- Primary completion
- Sep 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lobene Stain Index of Stain Extent Scores 4 Weeks After Dentifrice Use |
1.35; 1.64 | — |
| PRIMARY Lobene Stain Index of Stain Area Scores 4 Weeks After Dentifrice Use |
1.1; 1.32 | — |
| PRIMARY Lobene Stain Index of Stain Composite Scores 4 Weeks After Dentifrice Use |
2.39; 3.23 | — |
| PRIMARY Lobene Stain Index of Stain Extent Scores 8 Weeks After Dentifrice Use |
0.98; 1.33 | — |
| PRIMARY Lobene Stain Index of Stain Area Scores 8 Weeks After Dentifrice Use |
0.83; 1.12 | — |
| PRIMARY Lobene Stain Index of Stain Composite Scores 8 Weeks After Dentifrice Use |
1.45; 2.5 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT04238429). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.