Clinical Study of the Whitening Dentifrices on Tooth Color and Sensitivity

NCT ID: NCT02483013

Last Updated: 2015-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2014-12-31

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).

Detailed Description

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Conditions

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Dentin Hypersensitivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Whitening dentifrices

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

Group Type ACTIVE_COMPARATOR

whitening dentifrices

Intervention Type 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

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type 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

Interventions

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whitening dentifrices

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

Intervention Type OTHER

Placebo

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

Intervention Type OTHER

Other Intervention Names

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Colgate Luminous White® Close up White Now® Sorriso®

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Camila Tirapelli

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Camila Tirapeli, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo Ribeirão Preto Campus

Locations

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University of Sao Paulo, Ribeirao Preto Campus

Ribeirão Preto, São Paulo, Brazil

Site Status

Countries

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Brazil

Related Links

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http://www.forp.usp.br

Dental School of Ribeirão Preto website

Other Identifiers

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01546412.4.0000.5419

Identifier Type: -

Identifier Source: org_study_id

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