Clinical Study of the Whitening Dentifrices on Tooth Color and Sensitivity

University of Sao Paulo

Status and phase: Completed; Phase 4

Conditions: Dentin Hypersensitivity

Treatments: Other: Placebo; Other: whitening dentifrices

Study type: Interventional

Funder types: Other

Identifiers

NCT02483013

01546412.4.0000.5419

Details and patient eligibility

About

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).

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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
• Smokers

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Whitening dentifrices

Active Comparator group

Description:

Two groups used whitening dentifrices, three times per day during four weeks

Treatment:

Other: whitening dentifrices

Placebo

Placebo Comparator group

Description:

One group used conventional dentifrice, three times per day during four weeks

Treatment:

Other: Placebo