Clinical Study of the Whitening Dentifrices on Tooth Color and Sensitivity

Study Overview
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Brief Summary
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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).

Official Title
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Clinical, Controlled, Double-blind Study on the Effect of Whitening Dentifrices on Tooth Color and Tooth Sensitivity

Conditions
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Dentin Hypersensitivity

Intervention / Treatment
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* Other: whitening dentifrices
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Whitening dentifrices<br>Two groups used whitening dentifrices, three times per day during four weeks | Other: whitening dentifrices<br>* Two groups: participants received the instructions to use only the blinded supplied whitening dentifrice (Colgate Luminous White® or Close up White Now®) and toothbrush to make the habitual oral hygiene, three times per day during four weeks<br>* Other names: Close up White Now®;|
| Placebo Comparator: Placebo<br>One group used conventional dentifrice, three times per day during four weeks | Other: Placebo<br>* One group: participants received the instructions to use only the blinded supplied non-whitening dentifrice (Sorriso®) and toothbrush to make the habitual oral hygiene, three times per day during four weeks<br>* Other names: Sorriso®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tooth color | Tooth color was measured by Vita Easyshade spectrophotometer over a 4 weeks time frame. | 4 weeks | 
| Tooth sensitivity | 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). | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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whitening dentifrices, color alteration, tooth sensitivity