Clinical Study of the Whitening Dentifrices on Tooth Color and Sensitivity

Phase 4

Completed

• Conditions: Dentin Hypersensitivity
• Interventions: Other: whitening dentifrices; Other: Placebo

• Registration Number: NCT02483013
• Lead Sponsor: University of Sao Paulo

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08
• Primary Completion: 2014-11
• Study Completion: 2014-12
• Status Verified: 2015-06
• Study First Submitted: 2015-06-15
• Study First Submitted QC: 2015-06-25
• Last Update Submitted: 2015-06-25
• Study First Posted: 2015-06-26
• Last Update Posted: 2015-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• At least six anterior teeth without restorations
• Participants should have good general and oral health (no dental caries and periodontal disease)

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Exclusion Criteria

• Tooth sensitivity
• Any condition that could cause tooth sensitivity (non-carious cervical lesions, dentin exposure)
• Participants following orthodontic treatment
• Smokers

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Whitening dentifrices	whitening dentifrices	Two groups used whitening dentifrices, three times per day during four weeks
Placebo	Placebo	One group used conventional dentifrice, three times per day during four weeks

Primary Outcome Measures

Name	Time	Method
Tooth color	4 weeks	Tooth color was measured by Vita Easyshade spectrophotometer over a 4 weeks time frame.
Tooth sensitivity	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).

Trial Locations

Locations (1)

University of Sao Paulo, Ribeirao Preto Campus; 🇧🇷 Ribeirão Preto, Sao Paulo, Brazil