Posteruptive Color Change of ToothNCT01998386
Tooth Whitening With Hydrogenperoxide in Adolescents
A study testing 6.0% hydrogen peroxide - White Class, 7.5% hydrogen peroxide - White Class and 7.5% hydrogen peroxide - Oral-B 3D White in people with Posteruptive Color Change of Tooth, run by University of Nove de Julho at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 20 years
- Conditions the study is for
- Posteruptive Color Change of Tooth
- What is being tested?
- 6.0% hydrogen peroxide - White Class, 7.5% hydrogen peroxide - White Class and 7.5% hydrogen peroxide - Oral-B 3D White
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2013to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Marcelo M Pinto contact
Sandra K Bussadori contact
Brazil1 site, 1 recruiting
- Recruiting
University of Nove de Julho
São Paulo, São Paulo, 01504-001
Marcelo M Pinto, mmpdent@uninove.br
Sandra K Bussadori, sandra.skb@gmail.com
About this study
Official title: Tooth Whitening With Hydrogenperoxide in Adolescents - Controlled Clinical Trial
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.
Read the 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.
- Conditions
- Posteruptive Color Change of Tooth
- Being tested
- Placebo gel without hydrogen peroxide, 6.0% hydrogen peroxide - White Class, 7.5% hydrogen peroxide - White Class, 7.5% hydrogen peroxide - Oral-B 3D White
- Keywords
- Tooth Whitening, Adolescent, Clinical Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo gel without hydrogen peroxideOther
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 ClassOther
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 ClassOther
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 WhiteOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Placebo gel without hydrogen peroxide | Placebo comparator | The volunteers of this group will receive a placebo gel without hydrogen peroxide for whitening treatment. Receives: Other: Placebo gel without hydrogen peroxide |
| 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. Receives: Other: 6.0% hydrogen peroxide - White Class |
| 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. Receives: Other: 7.5% hydrogen peroxide - White Class |
| 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. Receives: Other: 7.5% hydrogen peroxide - Oral-B 3D White |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change of teeth color after 7 days of the beginning of treatment
Secondary outcomes (1)
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.
Measured: Sensivity alteration after 7 days of the beginning of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionMar 2014 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Posteruptive Color Change of ToothStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandra Kalil Bussadori, University of Nove de Julho
- Investigators
- Sandra K Bussadori, Principal investigator, University of Nove de JulhoMarcelo M Pinto, Study chair, University of Nove de JulhoCamila HL Godoy, Study chair, University of Nove de JulhoRubia G Lopes, Study chair, University of Nove de JulhoZenildo S Silva Junior, Study chair, University of Nove de JulhoSilvia RG Olivan, Study chair, University of Nove de JulhoLara J Motta, Study chair, University of Nove de JulhoOlga M Altavista, Study chair, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01998386
- Sponsor's protocol ID
- TWHPA
- Status last verified
- Sep 2013
- First submitted
- 15 Sep 2013
- Last updated
- 28 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 28355362Pinto 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.
PubMed 25315893
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tooth Whitening With Hydrogenperoxide in Adolescents - Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT01998386
- Acronym / sponsor ID
- TWHPA
- Conditions
- Posteruptive Color Change of Tooth
- Keywords
- Tooth Whitening, Adolescent, Clinical Trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Mar 2014 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 28 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo gel without hydrogen peroxide | Placebo comparator | Other: Placebo gel without hydrogen peroxideThe volunteers of this group will receive a placebo gel without hydrogen peroxide for whitening treatment. |
| 6.0% hydrogen peroxide - White Class | Experimental | Other: 6.0% hydrogen peroxide - White ClassVolunteers 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 | Other: 7.5% hydrogen peroxide - White ClassThe 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 | Other: 7.5% hydrogen peroxide - Oral-B 3D WhiteThe participants in this group will receive disposable whitening strips - Oral-B 3D White for whitening treatment. |
Who may qualify
- Ages
- 12 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo gel without hydrogen peroxideCastings 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. | Other | Placebo gel without hydrogen peroxide |
| 6.0% hydrogen peroxide - White ClassCastings 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. | Other | 6.0% hydrogen peroxide - White Class |
| 7.5% hydrogen peroxide - White ClassCastings 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. | Other | 7.5% hydrogen peroxide - White Class |
| 7.5% hydrogen peroxide - Oral-B 3D WhiteThe 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. | Other | 7.5% hydrogen peroxide - Oral-B 3D White |
Primary outcome
Discoloration
Time frame: Change of teeth color after 7 days of the beginning of treatment
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.
1 secondary outcome
Dental sensitivity
Time frame: Sensivity alteration after 7 days of the beginning of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2013.
- Derived from this study: PubMed 28355362Pinto 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.
- Derived from this study: PubMed 25315893Pinto 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcelo M Pinto contact
Sandra K Bussadori contact
Sandra K Bussadori principal investigator
University of Nove de Julho
Marcelo M Pinto study chair
University of Nove de Julho
Camila HL Godoy study chair
University of Nove de Julho
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 6.0% hydrogen peroxide - White Class, 7.5% hydrogen peroxide - White Class and 7.5% hydrogen peroxide - Oral-B 3D White in people with Posteruptive Color Change of Tooth, run by University of Nove de Julho at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marcelo M Pinto (mmpdent@uninove.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Discoloration (time frame: Change of teeth color after 7 days of the beginning of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01998386, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2013.