Tooth Whitening With Hydrogenperoxide in Adolescents
Information source: University of Nove de Julho
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Posteruptive Color Change of Tooth
Intervention: 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 (Other)
Phase: N/A
Status: Recruiting
Sponsored by: University of Nove de Julho Official(s) and/or principal investigator(s): Sandra K Bussadori, Principal Investigator, Affiliation: University of Nove de Julho Marcelo M Pinto, Study Chair, Affiliation: University of Nove de Julho Camila HL Godoy, Study Chair, Affiliation: University of Nove de Julho Rubia G Lopes, Study Chair, Affiliation: University of Nove de Julho Zenildo S Silva Junior, Study Chair, Affiliation: University of Nove de Julho Silvia RG Olivan, Study Chair, Affiliation: University of Nove de Julho Lara J Motta, Study Chair, Affiliation: University of Nove de Julho Olga M Altavista, Study Chair, Affiliation: University of Nove de Julho Katia Lumi, Study Chair, Affiliation: University of Nove de Julho Ana Paula T Sobral, Study Chair, Affiliation: FGM
Overall contact: Marcelo M Pinto, Email: mmpdent@uninove.br
Summary
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.
Clinical Details
Official title: Tooth Whitening With Hydrogenperoxide in Adolescents - Controlled Clinical Trial
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Primary outcome: Discoloration
Secondary outcome: Dental sensitivity
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
Minimum age: 12 Years.
Maximum age: 20 Years.
Gender(s): Both.
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.
Locations and Contacts
Marcelo M Pinto, Email: mmpdent@uninove.br
University of Nove de Julho, Sao Paulo 01504-001, Brazil; Recruiting Marcelo M Pinto, Email: mmpdent@uninove.br Sandra K Bussadori, Email: sandra.skb@gmail.com Sandra K Bussadori, Principal 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, Sub-Investigator
Additional Information
Starting date: November 2013
Last updated: November 23, 2013
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