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Clinical Study of the Whitening Dentifrices on Tooth Color and Sensitivity

Primary Purpose

Dentin Hypersensitivity

Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
whitening dentifrices
Placebo
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dentin Hypersensitivity focused on measuring whitening dentifrices, color alteration, tooth sensitivity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Sao Paulo, Ribeirao Preto Campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Whitening dentifrices

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 15, 2015
Last Updated
June 25, 2015
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT02483013
Brief Title
Clinical Study of the Whitening Dentifrices on Tooth Color and Sensitivity
Official Title
Clinical, Controlled, Double-blind Study on the Effect of Whitening Dentifrices on Tooth Color and Tooth Sensitivity
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dentin Hypersensitivity
Keywords
whitening dentifrices, color alteration, tooth sensitivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Whitening dentifrices
Arm Type
Active Comparator
Arm Description
Two groups used whitening dentifrices, three times per day during four weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
One group used conventional dentifrice, three times per day during four weeks
Intervention Type
Other
Intervention Name(s)
whitening dentifrices
Other Intervention Name(s)
Colgate Luminous White®, Close up White Now®
Intervention Description
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
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sorriso®
Intervention Description
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
Primary Outcome Measure Information:
Title
Tooth color
Description
Tooth color was measured by Vita Easyshade spectrophotometer over a 4 weeks time frame.
Time Frame
4 weeks
Title
Tooth sensitivity
Description
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).
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Camila Tirapeli, PhD
Organizational Affiliation
University of Sao Paulo Ribeirão Preto Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Sao Paulo, Ribeirao Preto Campus
City
Ribeirão Preto
State/Province
Sao Paulo
ZIP/Postal Code
14040-904
Country
Brazil

12. IPD Sharing Statement

Links:
URL
http://www.forp.usp.br
Description
Dental School of Ribeirão Preto website

Learn more about this trial

Clinical Study of the Whitening Dentifrices on Tooth Color and Sensitivity

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