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Tooth Whitening With Hydrogenperoxide in Adolescents

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by University of Nove de Julho
Sponsor:
Information provided by (Responsible Party):
Sandra Kalil Bussadori, University of Nove de Julho
ClinicalTrials.gov Identifier:
NCT01998386
First received: September 15, 2013
Last updated: November 23, 2013
Last verified: September 2013
  Purpose

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.

Condition Intervention
Posteruptive Color Change of Tooth
Other: Placebo gel without hydrogen peroxide
Other: 6.0% hydrogen peroxide - White Class
Other: 7.5% hydrogen peroxide - White Class
Other: 7.5% hydrogen peroxide - Oral-B 3D White

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Tooth Whitening With Hydrogenperoxide in Adolescents - Controlled Clinical Trial

Resource links provided by NLM:


Further study details as provided by University of Nove de Julho:

Primary Outcome Measures:
  • Discoloration [ Time Frame: Change of teeth color after 7 days of the beginning of treatment ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Dental sensitivity [ Time Frame: Sensivity alteration after 7 days of the beginning of treatment ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 64
Study Start Date: November 2013
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   12 Years to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01998386

Contacts
Contact: Marcelo M Pinto mmpdent@uninove.br
Contact: Sandra K Bussadori sandra.skb@gmail.com

Locations
Brazil
University of Nove de Julho Recruiting
Sao Paulo, Brazil, 01504-001
Contact: Marcelo M Pinto       mmpdent@uninove.br   
Contact: Sandra K Bussadori       sandra.skb@gmail.com   
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         
Sponsors and Collaborators
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: Lara J Motta 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
  More Information

No publications provided

Responsible Party: Sandra Kalil Bussadori, Professor, University of Nove de Julho
ClinicalTrials.gov Identifier: NCT01998386     History of Changes
Other Study ID Numbers: TWHPA
Study First Received: September 15, 2013
Last Updated: November 23, 2013
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Nove de Julho:
Tooth Whitening
Adolescent
Clinical Trial

Additional relevant MeSH terms:
Tooth Discoloration
Tooth Diseases
Stomatognathic Diseases
Hydrogen Peroxide
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014