Clinical, Controlled, Double-blind Study on the Effect of Whitening Dentifrices on Tooth Color and Tooth Sensitivity
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- University of Sao Paulo
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Tooth color
Study Overview
Brief Summary
Objective:The aim of this clinical study was to evaluate tooth color alteration (ΔE) and tooth sensitivity (TS) in patients that used two commercial brand-whitening dentifrices for four weeks. Sixty participants were selected in accordance with inclusion and exclusion criteria and randomly allocated in three groups (n=20): G1-Colgate Luminous White®, G2- Close up White Now® and G3- Sorriso® dentifrice (placebo). Then, participants received the instructions to use only the blinded supplied dentifrice and toothbrush to make the habitual oral hygiene, three times per day during four weeks. Evaluators assessed tooth color (CIEL*a*b system) and TS (VAS scale) at baseline and every week (assessment points 1, 2, 3 and 4). Two-way ANOVA and posterior Tukey and Friedman test analyzed data (α = 0.05).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •At least six anterior teeth without restorations
- •Participants should have good general and oral health (no dental caries and periodontal disease)
Exclusion Criteria
- •Tooth sensitivity
- •Any condition that could cause tooth sensitivity (non-carious cervical lesions, dentin exposure)
- •Participants following orthodontic treatment
Arms & Interventions
Whitening dentifrices
Two groups used whitening dentifrices, three times per day during four weeks
Intervention: whitening dentifrices (Other)
Placebo
One group used conventional dentifrice, three times per day during four weeks
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
Tooth color
Time Frame: 4 weeks
Tooth color was measured by Vita Easyshade spectrophotometer over a 4 weeks time frame.
Tooth sensitivity
Time Frame: 4 weeks
The pain caused by dentin hypersensitivity was measured over a 4 weeks time frame. The investigators stimulated the cervical region of the teeth with a blast of air from a triple syringe and patients reported pain intensity in accordance to Visual Analogue Scale (0= no pain, 10= pain bad as can be).
Secondary Outcomes
No secondary outcomes reported
Investigators
Camila Tirapelli
PhD
University of Sao Paulo