Efficacy of a Whitening Dentifrice on Tooth Discoloration

NCT02741427 | Completed Phase 4

• 1 other identifier: FUofParabia
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study was to compare the whitening effect of a toothpaste containing blue pigment with a conventional toothpaste and with at-home tooth bleaching; evaluate the subject's perception about tooth color improvement and; and evaluate the safety and acceptability of these products.

Conditions

Tooth Discoloration

Keywords

Tooth discoloration; Toothpaste; Tooth bleaching; Clinical trial

Outcome Measures

Primary Outcomes (1)

• Tooth shade changes from baseline until 4 weeks of the beginning of intervention

  The tooth shade evaluation was performed at each time frame using the digital spectrophotometer that provided tooth shade via two different methods: using the 16 shade tabs in the Vita shade guide (B1-C4); and the CIEL\*a\*b\* color system. The difference between the color coordinates was calculated as: ∆E\*= \[(∆L\*)2 + (∆a\*)2 + (∆b\*)2\]1/2, where ΔL\*, Δa\*, and Δb\* are the mathematical differences among CIE L\*, a\*, and b\* at the different time frames and baseline measurements.

  Baseline, Immediately after first product application, 2 weeks and 4 weeks of the beginning of interventions

Secondary Outcomes (3)

• Subjects' perception about improvement on tooth color

  2 weeks of the beginning of interventions

• Tooth sensitivity and gingival irritation evaluation

  Daily during three weeks

• Acceptability of interventions

  2 weeks of the beginning of interventions

Study Arms (3)

G1 (group 1) - Conventional toothpaste

PLACEBO COMPARATOR

G1 used a conventional toothpaste in daily oral regimen

Other: Conventional toothpaste

G2 (group 2) - Whitening toothpaste

EXPERIMENTAL

G2 used a whitening toothpaste containing blue pigment in daily oral regimen

Other: Whitening toothpaste

G3 (group 3) - 10 % Carbamide peroxide

ACTIVE COMPARATOR

G3 made an at-home tooth bleaching with 10 % Carbamide peroxide

Other: 10% carbamide peroxide

Interventions

Conventional toothpaste OTHER

The participants should brush their teeth with conventional toothpaste for 90 seconds, twice per day, during two weeks.They should place a pea-size amount of toothpaste on their toothbrushes, use dental floss, but not mouth rinse.

Also known as: Colgate Máxima Proteção Anticáries

G1 (group 1) - Conventional toothpaste

Whitening toothpaste OTHER

The subjects should brush teeth with whitening toothpaste containing blue pigment for 90 seconds, twice per day, during two weeks.They should place a pea-size amount of toothpaste on toothbrushes, use dental floss, but not mouth rinse.

Also known as: Close up White Now

G2 (group 2) - Whitening toothpaste

10% carbamide peroxide OTHER

The subjects should dispense the bleaching gel at night into the trays (maxillary and mandibular) and to insert them to cover at least the anterior teeth for a period of 4 h per day, over a 2-week period. Both arches should be bleached at the same time. During the period of bleaching, volunteers should receive the same toothpaste used by G1, in other words, without "whitening agents", to standardize their oral hygiene regimen

Also known as: Whiteness perfect 10%

G3 (group 3) - 10 % Carbamide peroxide

Eligibility Criteria

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

You may qualify if:

• To have six maxillary anterior teeth with a mean shade of C1 or darker (Vitapan Classical, Vita Zahnfabrik, Bad Sackingen, Germany),

You may not qualify if:

• With active caries or periodontal disease,
• Presenting non-vital anterior teeth,
• Previous hypersensitivity,
• Under orthodontic treatment,
• With structural defect in the enamel,
• Who had used tooth whiteners within the previous 3 years,
• Smokers,
• Pregnant or lactating

Sponsors & Collaborators

• Federal University of Paraíba: lead
• Unilever R&D: collaborator

Related Publications (2)

• Meireles SS, Santos IS, Bona AD, Demarco FF. A double-blind randomized clinical trial of two carbamide peroxide tooth bleaching agents: 2-year follow-up. J Dent. 2010 Dec;38(12):956-63. doi: 10.1016/j.jdent.2010.08.003. Epub 2010 Aug 13.

  PMID: 20709137 BACKGROUND

• Walsh TF, Rawlinson A, Wildgoose D, Marlow I, Haywood J, Ward JM. Clinical evaluation of the stain removing ability of a whitening dentifrice and stain controlling system. J Dent. 2005 May;33(5):413-8. doi: 10.1016/j.jdent.2004.10.021. Epub 2004 Dec 20.

  PMID: 15833397 BACKGROUND

MeSH Terms

Conditions

Tooth Discoloration

Interventions

hydrated silica gel-based toothpaste; Carbamide Peroxide

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Peroxides; Oxides; Anions; Ions; Electrolytes; Inorganic Chemicals; Reactive Oxygen Species; Free Radicals; Oxygen Compounds; Urea; Amides; Organic Chemicals

Study Officials

• Jossaria P Sousa, Master

  Federal University of Paraiba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master degree in Dentistry

Study Record Dates

• First Submitted: April 11, 2016
• First Posted: April 18, 2016
• Study Start: September 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: August 1, 2014
• Last Updated: April 18, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share