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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

Page last updated: August 23, 2015

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