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The specific objective of this study is:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo gel without hydrogen peroxide | Placebo Comparator | The volunteers of this group will receive a placebo gel without hydrogen peroxide for whitening treatment. |
|
| 6.0% hydrogen peroxide - White Class | Experimental | Volunteers of this group will receive a gel with 6.0% hydrogen peroxide - White Class with calcium for whitening treatment. |
|
| 7.5% hydrogen peroxide - White Class | Experimental | The volunteers of this group will receive a gel with 7.5% hydrogen peroxide -White Class with calcium for whitening treatment. |
|
| 7.5% hydrogen peroxide - Oral-B 3D White | Experimental | The participants in this group will receive disposable whitening strips - Oral-B 3D White for whitening treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo gel without hydrogen peroxide | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Discoloration | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Dental sensitivity | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marcelo M Pinto | Contact | mmpdent@uninove.br | ||
| Sandra K Bussadori | Contact | sandra.skb@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Sandra K Bussadori | University of Nove de Julho | Principal Investigator |
| Marcelo M Pinto | University of Nove de Julho | Study Chair |
| Camila HL Godoy |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Nove de Julho | Recruiting | São Paulo | São Paulo | 01504-001 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28355362 | Derived | 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. | |
| 25315893 |
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| ID | Term |
|---|---|
| D006861 | Hydrogen Peroxide |
| ID | Term |
|---|---|
| D010545 | Peroxides |
| D010087 | Oxides |
| D000838 | Anions |
| D007477 | Ions |
| D004573 |
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|
| 6.0% hydrogen peroxide - White Class | Other | 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. |
|
| 7.5% hydrogen peroxide - White Class | Other | 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. |
|
| 7.5% hydrogen peroxide - Oral-B 3D White | Other | 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. |
|
| Sensivity alteration after 7 days of the beginning of treatment |
| 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 | Study Chair |
| 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. |
| Electrolytes |
| D007287 | Inorganic Chemicals |
| D017382 | Reactive Oxygen Species |
| D005609 | Free Radicals |
| D017601 | Oxygen Compounds |
| D009930 | Organic Chemicals |