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Tooth Whitening With Hydrogenperoxide in Adolescents

NCT ID: NCT01998386

Last Updated: 2013-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2017-09-30

Brief Summary

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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

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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.

Conditions

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Posteruptive Color Change of Tooth

Keywords

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Tooth Whitening Adolescent Clinical Trial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Placebo gel without hydrogen peroxide

The volunteers of this group will receive a placebo gel without hydrogen peroxide for whitening treatment.

Group Type PLACEBO_COMPARATOR

Placebo gel without hydrogen peroxide

Intervention Type 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.

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.

Group Type EXPERIMENTAL

6.0% hydrogen peroxide - White Class

Intervention Type 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

The volunteers of this group will receive a gel with 7.5% hydrogen peroxide -White Class with calcium for whitening treatment.

Group Type EXPERIMENTAL

7.5% hydrogen peroxide - White Class

Intervention Type 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

The participants in this group will receive disposable whitening strips - Oral-B 3D White for whitening treatment.

Group Type EXPERIMENTAL

7.5% hydrogen peroxide - Oral-B 3D White

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Nove de Julho

OTHER

Sponsor Role lead

Responsible Party

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Sandra Kalil Bussadori

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sandra K Bussadori

Role: PRINCIPAL_INVESTIGATOR

University of Nove de Julho

Marcelo M Pinto

Role: STUDY_CHAIR

University of Nove de Julho

Camila HL Godoy

Role: STUDY_CHAIR

University of Nove de Julho

Rubia G Lopes

Role: STUDY_CHAIR

University of Nove de Julho

Zenildo S Silva Junior

Role: STUDY_CHAIR

University of Nove de Julho

Silvia RG Olivan

Role: STUDY_CHAIR

University of Nove de Julho

Lara J Motta

Role: STUDY_CHAIR

University of Nove de Julho

Olga M Altavista

Role: STUDY_CHAIR

University of Nove de Julho

Katia Lumi

Role: STUDY_CHAIR

University of Nove de Julho

Ana Paula T Sobral

Role: STUDY_CHAIR

FGM

Locations

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University of Nove de Julho

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Marcelo M Pinto

Role: CONTACT

Email: [email protected]

Sandra K Bussadori

Role: CONTACT

Email: [email protected]

Facility Contacts

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Marcelo M Pinto

Role: primary

Sandra K Bussadori

Role: backup

References

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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.

Reference Type DERIVED
PMID: 28355362 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25315893 (View on PubMed)

Other Identifiers

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TWHPA

Identifier Type: -

Identifier Source: org_study_id