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Completed

NCT Number: NCT02483013

Clinical Study of the Whitening Dentifrices on Tooth Color and Sensitivity

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).

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Key information

Conditions

Dentin Hypersensitivity Dentin Sensitivity Stomatognathic Diseases Tooth Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Sao Paulo, Ribeirao Preto Campus

Ribeirão Preto, São Paulo, 14040-904, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

whitening dentifrices

Other

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

Other names: Colgate Luminous White®, Close up White Now®

Placebo

Other

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

Other names: Sorriso®

Primary outcomes

  1. Tooth color

    Time frame: 4 weeks

    Tooth color was measured by Vita Easyshade spectrophotometer over a 4 weeks time frame.

  2. 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).

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jun 26, 2015
Registry last updated
Jun 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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