Clinical trial NCT01998386: Tooth Whitening With Hydrogenperoxide in Adolescents
Official title: Tooth Whitening With Hydrogenperoxide in Adolescents - Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Posteruptive Color Change of Tooth
Keywords: Tooth Whitening
Adolescent
Clinical Trial
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2013-11-28
Enrollment: 64
Sex: ALL
Minimum age (years): 12
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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.

Primary outcomes:
measure: Discoloration
timeFrame: Change of teeth color after 7 days of the beginning of treatment
Secondary outcomes:
measure: Dental sensitivity
timeFrame: Sensivity alteration after 7 days of the beginning of treatment
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: University of Nove de Julho
Study officials:
affiliation: University of Nove de Julho
name: Sandra K Bussadori
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Nove de Julho
name: Marcelo M Pinto
role: STUDY_CHAIR
affiliation: University of Nove de Julho
name: Camila HL Godoy
role: STUDY_CHAIR
affiliation: University of Nove de Julho
name: Rubia G Lopes
role: STUDY_CHAIR
affiliation: University of Nove de Julho
name: Zenildo S Silva Junior
role: STUDY_CHAIR
affiliation: University of Nove de Julho
name: Silvia RG Olivan
role: STUDY_CHAIR
affiliation: University of Nove de Julho
name: Lara J Motta
role: STUDY_CHAIR
affiliation: University of Nove de Julho
name: Olga M Altavista
role: STUDY_CHAIR
affiliation: University of Nove de Julho
name: Katia Lumi
role: STUDY_CHAIR
affiliation: FGM
name: Ana Paula T Sobral
role: STUDY_CHAIR
References:
citation: Pinto MM, Goncalves ML, Mota AC, Deana AM, Olivan SR, Bortoletto C, Godoy CH, Vergilio KL, Altavista OM, Motta LJ, Bussadori SK. Controlled clinical trial addressing teeth whitening with hydrogen peroxide in adolescents: a 12-month follow-up. Clinics (Sao Paulo). 2017 Mar;72(3):161-170. doi: 10.6061/clinics/2017(03)06.
citation: Pinto MM, de Godoy CH, Bortoletto CC, Olivan SR, Motta LJ, Altavista OM, Lumi K, Sobral AP, Bussadori SK. Tooth whitening with hydrogen peroxide in adolescents: study protocol for a randomized controlled trial. Trials. 2014 Oct 14;15:395. doi: 10.1186/1745-6215-15-395.