Tooth Whitening With Hydrogenperoxide in Adolescents

November 23, 2013 updated by: Sandra Kalil Bussadori, University of Nove de Julho

Tooth Whitening With Hydrogenperoxide in Adolescents - Controlled Clinical Trial

The specific objective of this study is:

  • Evaluate and quantify colorimetric changes in young permanent anterior teeth;
  • Compare the efficiency and efficacy of three gels used for self-administered home whitening and an over the counter whitening strip;
  • Analyze the increase in dental sensitivity in adolescent patients submitted to home whitening with 6% and 7.5% hydrogen peroxide with and without the addition of calcium (whitening strips);
  • Assess sensitivity, comfort and acceptance of whitening strips by patients;
  • Assess patient satisfaction with the method and material used for home whitening.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The aim of the proposed controlled clinical trial will be to assess colorimetric changes and increased dental sensitivity in adolescent patients submitted to tooth whitening with 6% and 7.5% hydrogen peroxide using home kits with whitening strips. Adolescents aged 12 to 20 years will be allocated to different groups based on treatment (n = 16 per group): 1) placebo; 2) 6.0% hydrogen peroxide (White Class with calcium - FGM); 3) 7.5% hydrogen peroxide (White Class with calcium - FGM); and 4) 7.5% hydrogen peroxide (Oral B 3D White - Oral-B). After the whitening procedures, the participants will be evaluated using a visual analogue scale for tooth sensitivity and digital spectrophotometry for the measurement of changes in color.

Study Type

Interventional

Enrollment (Anticipated)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 01504-001
        • Recruiting
        • University of Nove de Julho
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sandra K Bussadori
        • Sub-Investigator:
          • Marcelo M Pinto
        • Sub-Investigator:
          • Camila HL Godoy
        • Sub-Investigator:
          • Rubia G Lopes
        • Sub-Investigator:
          • Zenildo S Silva Junior
        • Sub-Investigator:
          • Silvia RG Olivan
        • Sub-Investigator:
          • Lara J Motta
        • Sub-Investigator:
          • Olga M Altavista
        • Sub-Investigator:
          • Katia Lumi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 20 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 12 to 20 years; diagnosis of altered color on maxillary and mandibular anterior teeth with initial color equivalent to A2 on the Vita scale (Vita Zahnfabrik); signed statement of informed consent

Exclusion Criteria:

  • Dental anomalies (malformation, carious lesions, fractures); presence of at least four maxillary and/or mandibular anterior teeth; known adverse reaction to peroxide; use of whitening agents (administered in dental office or at home) in the previous year; currently undergoing orthodontic treatment, orthopedic treatment of the jaws or psychological treatment; use of medication that can alter the color of the teeth, such as ferrous sulfate.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo gel without hydrogen peroxide
The volunteers of this group will receive a placebo gel without hydrogen peroxide for whitening treatment.
Other: Placebo gel without hydrogen peroxide
Castings will be made of the upper and lower arches of the volunteers and plaster will be poured into the molds. Individual plastic molds (vacuum form, flexible acetate 1 mm in thickness) will be made for each arch using the plaster models. After fitting the molds in the oral cavity, the volunteers will receive oral and written instructions on how to use the whitening gel and will be instructed to perform proper oral hygiene with dental floss and a tooth brush prior to the application of the whitening agent. The volunteers will be instructed to use the molds with the gel one hour a day for seven days. Thirty days after the beginning of treatment, the volunteers in this group will receive the whitening treatment with 6.0% hydrogen peroxide - White Class with calcium.
Experimental: 6.0% hydrogen peroxide - White Class
Volunteers of this group will receive a gel with 6.0% hydrogen peroxide - White Class with calcium for whitening treatment.
Other: 6.0% hydrogen peroxide - White Class
Castings will be made of the upper and lower arches of the volunteers and plaster will be poured into the molds. Individual plastic molds (vacuum form, flexible acetate 1 mm in thickness) will be made for each arch using the plaster models. After fitting the molds in the oral cavity, the volunteers will receive oral and written instructions on how to use the whitening gel 6.0% hydrogen peroxide - White Class with calcium and will be instructed to perform proper oral hygiene with dental floss and a tooth brush prior to the application of the whitening agent. The volunteers will be instructed to use the molds with whitening gel one hour a day for seven days.
Experimental: 7.5% hydrogen peroxide - White Class
The volunteers of this group will receive a gel with 7.5% hydrogen peroxide -White Class with calcium for whitening treatment.
Other: 7.5% hydrogen peroxide - White Class
Castings will be made of the upper and lower arches of the volunteers and plaster will be poured into the molds. Individual plastic molds (vacuum form, flexible acetate 1 mm in thickness) will be made for each arch using the plaster models. After fitting the molds in the oral cavity, the volunteers will receive oral and written instructions on how to use the whitening gel 7.5% hydrogen peroxide - White Class with calciumand will be instructed to perform proper oral hygiene with dental floss and a tooth brush prior to the application of the whitening agent. The volunteers will be instructed to use the molds with whitening gel one hour a day for seven days.
Experimental: 7.5% hydrogen peroxide - Oral-B 3D White
The participants in this group will receive disposable whitening strips - Oral-B 3D White for whitening treatment.
Other: 7.5% hydrogen peroxide - Oral-B 3D White
The participants in this group will receive four disposable whitening 7.5% hydrogen peroxide - Oral-B 3D White strips for daily individual use. The volunteers will be instructed to perform proper oral hygiene with dental floss and a tooth brush prior to the application of the whitening strips. The volunteers will receive oral and written instructions on how to use the whitening strips, which will be placed on the surface of the teeth for 30 minutes twice a day for seven days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Discoloration
Time Frame: Change of teeth color after 7 days of the beginning of treatment

Color readings of the vestibular region of the maxillary and mandibular anterior teeth will be performed by a previously trained examiner blinded to the allocation of the volunteers to the different groups. A digital spectrophotometer will be used for the colorimetric evaluation.

It will be carried out in all groups at the following times: pre-treatment period, immediately following the first treatment period, after seven days, after 30 days, after six months, after 12 months, after 24 months, and after 48 months.
Change of teeth color after 7 days of the beginning of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dental sensitivity
Time Frame: Sensivity alteration after 7 days of the beginning of treatment

The volunteers will inform the degree of sensitivity at all evaluation times using a visual analog scale ranging from 0 (absence of sensitivity) to 10 (maximum sensitivity).

Evaluations of dental sensitivity will be carried out in all groups at the following times: pre-treatment period, immediately following the first treatment period, after seven days, after 30 days, after six months, after 12 months, after 24 months and after 48 months.
Sensivity alteration after 7 days of the beginning of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nove de Julho

Investigators

  • Principal Investigator: Sandra K Bussadori, University of Nove de Julho
  • Study Chair: Marcelo M Pinto, University of Nove de Julho
  • Study Chair: Camila HL Godoy, University of Nove de Julho
  • Study Chair: Rubia G Lopes, University of Nove de Julho
  • Study Chair: Zenildo S Silva Junior, University of Nove de Julho
  • Study Chair: Silvia RG Olivan, University of Nove de Julho
  • Study Chair: Olga M Altavista, University of Nove de Julho
  • Study Chair: Katia Lumi, University of Nove de Julho
  • Study Chair: Ana Paula T Sobral, FGM

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Anticipated)

March 1, 2014

Study Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

September 15, 2013

First Submitted That Met QC Criteria

November 23, 2013

First Posted (Estimate)

November 28, 2013

Study Record Updates

Last Update Posted (Estimate)

November 28, 2013

Last Update Submitted That Met QC Criteria

November 23, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TWHPA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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