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

NCT02414464 | Completed

• 1 other identifier: TBYP
• Study Type: interventional
• Target: 53
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Tooth Discoloration

Keywords

tooth bleaching; adolescent; clinical trial

Outcome Measures

Primary Outcomes (1)

• Discoloration

  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.

  Change of teeth color after 48 hours, after 6 months, after 12 months, after 18 months

Secondary Outcomes (1)

• Dental sensitivity

  Sensivity alteration up to 48 hours after the procedure

Study Arms (3)

35% hydrogen peroxide

EXPERIMENTAL

Volunteers of this group will receive a gel with 35% hydrogen peroxide - Whiteness HP 35% for whitening treatment.

Other: 35% hydrogen peroxide

35% hydrogen peroxide with calcium

EXPERIMENTAL

Volunteers of this group will receive a gel with 35% hydrogen peroxide with calcium - Whiteness HP Blue Calcium 35% for whitening treatment.

Other: 35% hydrogen peroxide

20% hydrogen peroxide with calcium

EXPERIMENTAL

Volunteers of this group will receive a gel with 35% hydrogen peroxide with calcium - Whiteness HP Blue Calcium 20% for whitening treatment.

Other: 20% hydrogen peroxide

Interventions

35% hydrogen peroxide OTHER

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.

Also known as: Whiteness HP 35%

35% hydrogen peroxide

20% hydrogen peroxide OTHER

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.

Also known as: Whiteness HP Blue Calcium 20%

20% hydrogen peroxide with calcium

Eligibility Criteria

• Age: 11 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nove de Julho: lead

MeSH Terms

Conditions

Tooth Discoloration

Interventions

Hydrogen 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; Organic Chemicals

Study Officials

• Sandra K Bussadori, Doctor

  University of Nove de Julho

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 9, 2014
• First Posted: April 10, 2015
• Study Start: February 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: May 1, 2015
• Last Updated: May 2, 2018

Record last verified: 2018-05