Tooth Bleaching for Young Patients Using a Hydrogen Peroxide-based Gel

NCT02414464 — Not applicable, Completed, 53 participants, University of Nove de Julho

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In-Office Tooth Bleaching for Young Patients Using a Hydrogen Peroxide-based Gel: a Randomized, Controlled, Clinical Trial

RegistryNCT02414464
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: none, treatment
Enrollment53 (Actual)
SponsorUniversity of Nove de Julho (Other)
ConditionsTooth Discoloration
Interventions35% hydrogen peroxide, 20% hydrogen peroxide (Other)
Datesstart 2013-02-01, primary completion 2014-09-01, completion 2015-05-01, first posted 2015-04-10, last updated 2018-05-02

Related Papers Related Patents Related Grants Related Experts
All trials for Tooth Discoloration All trials of 35% hydrogen peroxide All trials of 20% hydrogen peroxide

-Summary

The aim of the present study was to evaluate colorimetric changes and tooth sensitivity in young patients submitted to tooth bleaching with 20% and 35% hydrogen peroxide.

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+Detailed description

A randomized, controlled, clinical trial was conducted with 53 patients aged 11 to 24 years who were allocated to groups based on the use of the following commercial products: Whiteness HP - FGM® (35% hydrogen peroxide); Whiteness HP Blue Calcium - FGM® (35% hydrogen peroxide); and Whiteness HP Blue Calcium - FGM® (20% hydrogen peroxide).

After the bleaching procedure, the visual analog scale was used to measure tooth sensitivity and the classic Vita® scale was used to determine changes in tooth color.

Statistical analysis involved the Friedman, Kruskal-Wallis and Student-Newman-Keuls tests, with p-value ≤ 0.05 or ≤ 0.0001 considered indicative of statistical significance.

+Arms and interventions

ArmTypeInterventionsDescription
35% hydrogen peroxideExperimentalOther: 35% hydrogen peroxideVolunteers of this group will receive a gel with 35% hydrogen peroxide - Whiteness HP 35% for whitening treatment.
35% hydrogen peroxide with calciumExperimentalOther: 35% hydrogen peroxideVolunteers of this group will receive a gel with 35% hydrogen peroxide with calcium - Whiteness HP Blue Calcium 35% for whitening treatment.
20% hydrogen peroxide with calciumExperimentalOther: 20% hydrogen peroxideVolunteers of this group will receive a gel with 35% hydrogen peroxide with calcium - Whiteness HP Blue Calcium 20% for whitening treatment.
  • 35% hydrogen peroxide (Other), also known as Whiteness HP 35%: Prophylaxis was performed with a jet of sodium bicarbonate to remove extrinsic pigments and plaque. Each patient underwent two bleaching sessions. A lip retractor (Arc Flex, FGM®) was placed. Cotton roles or gauze compresses were used to achieve relative isolation. A dental dam (Top Dam, FGM®) was placed over the free marginal gingival tissue and the inter-tooth papillae of teeth 14 to 24 in each session. The Whiteness HP 35% gel was applied to the vestibular faces of these teeth. In the present study, the Whiteness HP 35% gel was applied without an external auxiliary source. As this is not a self-catalyzed system, the gel was removed after each 15-minute application and reapplied two more times, totaling 45 minutes of contact with the teeth.
  • 35% hydrogen peroxide (Other), also known as Whiteness HP Blue Calcium 35%: Prophylaxis was performed with a jet of sodium bicarbonate to remove extrinsic pigments and plaque. Each patient underwent two bleaching sessions. A lip retractor (Arc Flex, FGM®) was placed. Cotton roles or gauze compresses were used to achieve relative isolation. A dental dam (Top Dam, FGM®) was placed over the free marginal gingival tissue and the inter-tooth papillae of teeth 14 to 24 in each session. The Whiteness HP Blue Calcium 35% gel was applied to the vestibular faces of these teeth for 40 minutes in each session.
  • 20% hydrogen peroxide (Other), also known as Whiteness HP Blue Calcium 20%: Prophylaxis was performed with a jet of sodium bicarbonate to remove extrinsic pigments and plaque. Each patient underwent two bleaching sessions. A lip retractor (Arc Flex, FGM®) was placed. Cotton roles or gauze compresses were used to achieve relative isolation. A dental dam (Top Dam, FGM®) was placed over the free marginal gingival tissue and the inter-tooth papillae of teeth 14 to 24 in each session. The Whiteness HP Blue Calcium 20% gel was applied to the vestibular faces of these teeth 50 minutes in each session.

+Outcome measures

Primary outcomes

  • Discoloration [Change of teeth color after 48 hours, after 6 months, after 12 months, after 18 months]: the initial tooth color was determined with the aid of the classic Vita® scale. Tooth color was recorded 48 hours after each session to determine the difference in tone before and after the procedures. It will be carried out in all groups at the following times: pre-treatment period, 48 hours following each session, after six months, after 12 months, after 18 months.

Secondary outcomes

  • Dental sensitivity [Sensivity alteration up to 48 hours after the procedure]: The visual analog scale was used for the subjective measure of sensitivity during and after the procedures.

+Eligibility

Sex: All, ages: 11 Years to 24 Years, accepts healthy volunteers

Inclusion Criteria:

* Individuals aged 11 to 24 years with a diagnosis of tooth discoloration and a signed statement of informed consent.

Exclusion Criteria:

* Individuals with dentofacial anomalies, those without the permanent dentition complete to the second molars, those in orthodontic or orthopedic treatment of the jaws, those who took medications that could alter tooth color and those who had previously been submitted to tooth bleaching

+Investigators