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

Tooth Discoloration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02414464
• Other study ID #: TBYP
• Status: Completed
• Phase: N/A
• Start date: February 2013
• Est. completion date: May 2015

Study information

• Verified date: May 2018
• Source: University of Nove de Julho
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: May 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

• Tooth Discoloration

Intervention

Other:
• 35% hydrogen peroxide
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
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
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Nove de Julho

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Dental sensitivity	The visual analog scale was used for the subjective measure of sensitivity during and after the procedures.	Sensivity alteration up to 48 hours after the procedure