Clinical Study of the Whitening Dentifrices on Tooth Color and Sensitivity

June 25, 2015 updated by: Camila Tirapelli, University of Sao Paulo

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Sao Paulo
      • Ribeirão Preto, Sao Paulo, Brazil, 14040-904
        • University of Sao Paulo, Ribeirao Preto Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Whitening dentifrices
Two groups used whitening dentifrices, three times per day during four weeks
Other: 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
Other Names:
  • Colgate Luminous White®
  • Close up White Now®
Placebo Comparator: Placebo
One group used conventional dentifrice, three times per day during four weeks
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
Other Names:
  • Sorriso®

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Investigators

  • Principal Investigator: Camila Tirapeli, PhD, University of Sao Paulo Ribeirão Preto Campus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

June 15, 2015

First Submitted That Met QC Criteria

June 25, 2015

First Posted (Estimate)

June 26, 2015

Study Record Updates

Last Update Posted (Estimate)

June 26, 2015

Last Update Submitted That Met QC Criteria

June 25, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01546412.4.0000.5419

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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