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Clinical Study of the Whitening Dentifrices on Tooth Color and Sensitivity

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02483013
Enrollment
60
Registered
2015-06-26
Start date
2014-08-31
Completion date
2014-12-31
Last updated
2015-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dentin Hypersensitivity

Keywords

whitening dentifrices, color alteration, tooth sensitivity

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).

Interventions

OTHERwhitening 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

OTHERPlacebo

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

Sponsors

University of Sao Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Tooth color4 weeksTooth color was measured by Vita Easyshade spectrophotometer over a 4 weeks time frame.
Tooth sensitivity4 weeksThe 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).

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026