Clinical Study of the Whitening Dentifrices on Tooth Color and Sensitivity

NCT02483013 | Completed Phase 4 DMC

• 1 other identifier: 01546412.4.0000.5419
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Dentin Hypersensitivity

Keywords

whitening dentifrices; color alteration; tooth sensitivity

Outcome Measures

Primary Outcomes (2)

• Tooth color

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

  4 weeks

• 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).

  4 weeks

Study Arms (2)

Whitening dentifrices

ACTIVE COMPARATOR

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

Other: whitening dentifrices

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

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

Also known as: Colgate Luminous White®, Close up White Now®

Whitening dentifrices

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

Also known as: Sorriso®

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least six anterior teeth without restorations
• Participants should have good general and oral health (no dental caries and periodontal disease)

You may not qualify if:

• Tooth sensitivity
• Any condition that could cause tooth sensitivity (non-carious cervical lesions, dentin exposure)
• Participants following orthodontic treatment
• Smokers

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

University of Sao Paulo, Ribeirao Preto Campus

Ribeirão Preto, São Paulo, 14040-904, Brazil

Location

Related Links

• Dental School of Ribeirão Preto website

MeSH Terms

Conditions

Dentin Sensitivity

Interventions

sorriso

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Camila Tirapeli, PhD

  University of Sao Paulo Ribeirão Preto Campus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: June 15, 2015
• First Posted: June 26, 2015
• Study Start: August 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: December 1, 2014
• Last Updated: June 26, 2015

Record last verified: 2015-06

Locations

BR (1)