Clinical Study of the Whitening Dentifrices on Tooth Color and Sensitivity

Dentin Hypersensitivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02483013
• Other study ID #: 01546412.4.0000.5419
• Status: Completed
• Phase: Phase 4
• First received: June 15, 2015
• Last updated: June 25, 2015
• Start date: August 2014
• Est. completion date: December 2014

Study information

• Verified date: June 2015
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in ResearchBrazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dentin Hypersensitivity
• Dentin Sensitivity
• Hypersensitivity

Intervention

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
• 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

Locations

Country	Name	City	State
Brazil	University of Sao Paulo, Ribeirao Preto Campus	Ribeirão Preto	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tooth color	Tooth color was measured by Vita Easyshade spectrophotometer over a 4 weeks time frame.	4 weeks	Yes
Primary	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	Yes

External Links

•   Dental School of Ribeirão Preto website