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Clinical Study of the Whitening Dentifrices on Tooth Color and Sensitivity

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ClinicalTrials.gov Identifier: NCT02483013
Recruitment Status : Completed
First Posted : June 26, 2015
Last Update Posted : June 26, 2015
Sponsor:
Information provided by (Responsible Party):
Camila Tirapelli, 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).

Condition or disease Intervention/treatment Phase
Dentin Hypersensitivity Other: whitening dentifrices Other: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Clinical, Controlled, Double-blind Study on the Effect of Whitening Dentifrices on Tooth Color and Tooth Sensitivity
Study Start Date : August 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

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 Name: Sorriso®




Primary Outcome Measures :
  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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02483013


Locations
Brazil
University of Sao Paulo, Ribeirao Preto Campus
Ribeirão Preto, Sao Paulo, Brazil, 14040-904
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Camila Tirapeli, PhD University of Sao Paulo Ribeirão Preto Campus

Additional Information:
Responsible Party: Camila Tirapelli, PhD, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02483013     History of Changes
Other Study ID Numbers: 01546412.4.0000.5419
First Posted: June 26, 2015    Key Record Dates
Last Update Posted: June 26, 2015
Last Verified: June 2015

Keywords provided by Camila Tirapelli, University of Sao Paulo:
whitening dentifrices
color alteration
tooth sensitivity

Additional relevant MeSH terms:
Hypersensitivity
Dentin Sensitivity
Immune System Diseases
Tooth Diseases
Stomatognathic Diseases