Efficacy of a Whitening Dentifrice on Tooth Discoloration

NCT ID: NCT02741427

Last Updated: 2016-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2014-08-31

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.

Detailed Description

The study was approved by local Ethical Committee under protocol number CAAE: 035541412.7.0000.5188, and each volunteer signed an informed consent form prior to enrollment in the study.

The sample size calculation was carried out based on a previous study. To detect the bleaching effect with a power of 80% and a one-tailed alpha error of 5%, a sample size of 20 subjects in each treatment group was necessary to detect a 20% difference between groups in shade change. A 20% addiction in subjects' number, taking into consideration potential loss or refusal, gave a total sample size of 75 subjects (25 in each group). The individuals were invited to participate in this clinical trial through advertisement exposed at the Federal University of Paraíba, Brazil.

Basing on eligibility criteria, 75 volunteers were selected to the trial and randomized to one of the three groups of treatment: G1- brushing teeth with a conventional toothpaste; G2- brushing teeth with a silica whitening dentifrice containing blue pigment; and G3 - at-home tooth bleaching with 10% carbamide peroxide. The treatments will be detailed in another section. It was used a simple randomization to allocate the subjects, and a randomization table was prepared in the Excel Program by a member, not directly involved with the clinical part of the study.

To mask the products used in the treatment groups, each toothpaste type was enveloped with an adhesive tape of a different color and the seal of the bleaching gel syringe was removed. The same examiner responsible for subject allocation did this procedure. Thus, testing with the toothpastes was double-blinded, where both evaluator and subject did not know which toothpaste was being used.

The outcomes evaluated were: tooth shade, subjects' perception about tooth color appearance, and safety and acceptability of products tested, which were measured at baseline, 2-weeks, 3-weeks and 4-weeks of the beginning of treatments.

For statistical analysis, data were checked for normal distribution using the Kolmogorov Smirnov test, and then it was applied the appropriated parametric or non-parametric tests. Differences were considered statistically significant when p < 0.05.

Conditions

Tooth Discoloration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

G1 (group 1) - Conventional toothpaste

G1 used a conventional toothpaste in daily oral regimen

Group Type: PLACEBO_COMPARATOR

Conventional toothpaste

Intervention Type: 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.

G2 (group 2) - Whitening toothpaste

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

Group Type: EXPERIMENTAL

Whitening toothpaste

Intervention Type: 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.

G3 (group 3) - 10 % Carbamide peroxide

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

Group Type: ACTIVE_COMPARATOR

10% carbamide peroxide

Intervention Type: 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

Interventions

Conventional toothpaste

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.

Intervention Type: OTHER

Whitening toothpaste

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.

Intervention Type: OTHER

10% carbamide peroxide

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

Intervention Type: OTHER

Other Intervention Names

Colgate Máxima Proteção Anticáries; Close up White Now; Whiteness perfect 10%

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Unilever R&D

INDUSTRY

Sponsor Role: collaborator

Federal University of Paraíba

OTHER

Sponsor Role: lead

Responsible Party

Jossaria Pereira de Sousa

Master degree in Dentistry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jossaria P Sousa, Master

Role: PRINCIPAL_INVESTIGATOR

Federal University of Paraiba

References

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.

Reference Type: BACKGROUND

PMID: 20709137 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15833397 (View on PubMed)

Other Identifiers

FUofParabia

Identifier Type: -

Identifier Source: org_study_id