Dentin SensitivityNCT01959789
In-office Bleaching With a 2-day Interval Between Sessions: Tooth Sensitivity
An observational study of Dentin Sensitivity, run by Universidade Estadual de Ponta Grossa at 1 site in Brazil.
Trial summary
The calcium containing 35% hydrogen peroxide gel employed in this study can be re-applied 2 days after the first bleaching session without increasing the bleaching-induced tooth sensitivity Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dentin Sensitivity
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2011to Aug 2012
- Phase
- Observational
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants included in this clinical trial were at least 18 years old and had good general and oral health. Participants were recruited by means of visual communication through posters in the university and in stores at Umuarama city. A total of 116 participants were examined in a dental chair to check if they met the inclusion and exclusion criteria.
Who may be able to join
- The participants should have:
- At least six maxillary and mandibular anterior teeth caries-free. Without restorations on the labial surfaces. The central incisors should be C2 or darker according to a value-oriented shade guide (Vita Lumin).
- -
Who cannot join
- Pre-existing anterior restorations. Pregnant/lactating. Severe internal tooth discoloration (tetracycline stains, fluorosis, pulpless teeth).
- Taking any drug with anti-inflammatory and antioxidant action. Bruxism habits or any other pathology that could cause Tooth Sensbility (such as recession, dentine exposure).
- -
Trial locations and contacts
1 site in 1 country.
About this study
The calcium containing 35% hydrogen peroxide gel employed in this study can be re-applied 2 days after the first bleaching session without increasing the bleaching-induced tooth sensitivity
Read the detailed description
The in-office bleaching uses 35% hydrogen peroxide gel which is applied in 2 to 3 sessions usually with one week interval between sessions, without a scientific and plausible reason for this recommendation (. The aim of this study was to evaluate the tooth sensitivity (TS) risk using a shorter interval between clinical sessions. Methods: In this randomized, single-blind study, 40 young patients with color C2 or darker were selected and randomly divided in two groups. In the 7-day group, two bleaching sessions with a 35% hydrogen peroxide gel (Whiteness HP Blue Calcium - FGM) were performed with a one-week interval and in the 2-day group, the same protocol was performed but with a 2-day interval. TS was recorded on a 0-10 visual analog scale up to 48 h after bleaching. The color evaluation was performed at baseline and 30 days after bleaching with a value-oriented shade guide and a spectrophotometer. The absolute risk of TS (%) was evaluated by Fisher´s exact. The TS intensity was evaluated by two-way repeated measured ANOVA and color changes (ΔSGU and ΔE) were evaluated by Student´s t-test (alpha = 5%).
- Conditions
- Dentin Sensitivity
- Keywords
- Randomized Controlled Clinical Trial, Tooth Bleaching
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control | Standard treatment | |
| 2 days | bleaching treatments made in 2 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tooth sensibility
Measured: 1 year
Secondary outcomes (1)
Color
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2013 (estimated)
- Study startAug 2011
- Primary completionDec 2011
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dentin SensitivityStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual de Ponta Grossa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eloisa Andrade de Paula, Universidade Estadual de Ponta Grossa
- Investigators
- Eloisa A Paula, MD, Principal investigator, Universidade Estadual de Ponta Grossa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01959789
- Sponsor's protocol ID
- 22564/2011
- Other IDs
- name, Name of trial
- Status last verified
- Oct 2013
- First submitted
- 6 Oct 2013
- Last updated
- 10 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
de Paula EA, Nava JA, Rosso C, Benazzi CM, Fernandes KT, Kossatz S, Loguercio AD, Reis A. In-office bleaching with a two- and seven-day intervals between clinical sessions: A randomized clinical trial on tooth sensitivity. J Dent. 2015 Apr;43(4):424-9. doi: 10.1016/j.jdent.2014.09.009. Epub 2014 Sep 23.
PubMed 25257824
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In-office Bleaching With a 2-day Interval Between Sessions: Tooth Sensitivity
- ClinicalTrials.gov ID
- NCT01959789
- Acronym / sponsor ID
- 22564/2011
- Conditions
- Dentin Sensitivity
- Keywords
- Randomized Controlled Clinical Trial, Tooth Bleaching
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universidade Estadual de Ponta GrossaUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 10 Oct 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 calcium containing 35% hydrogen peroxide gel employed in this study can be re-applied 2 days after the first bleaching session without increasing the bleaching-induced tooth sensitivity
Detailed description
The in-office bleaching uses 35% hydrogen peroxide gel which is applied in 2 to 3 sessions usually with one week interval between sessions, without a scientific and plausible reason for this recommendation (. The aim of this study was to evaluate the tooth sensitivity (TS) risk using a shorter interval between clinical sessions. Methods: In this randomized, single-blind study, 40 young patients with color C2 or darker were selected and randomly divided in two groups. In the 7-day group, two bleaching sessions with a 35% hydrogen peroxide gel (Whiteness HP Blue Calcium - FGM) were performed with a one-week interval and in the 2-day group, the same protocol was performed but with a 2-day interval. TS was recorded on a 0-10 visual analog scale up to 48 h after bleaching. The color evaluation was performed at baseline and 30 days after bleaching with a value-oriented shade guide and a spectrophotometer. The absolute risk of TS (%) was evaluated by Fisher´s exact. The TS intensity was evaluated by two-way repeated measured ANOVA and color changes (ΔSGU and ΔE) were evaluated by Student´s t-test (alpha = 5%).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | –Standard treatment |
| 2 days | – | –bleaching treatments made in 2 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants included in this clinical trial were at least 18 years old and had good general and oral health. Participants were recruited by means of visual communication through posters in the university and in stores at Umuarama city. A total of 116 participants were examined in a dental chair to check if they met the inclusion and exclusion criteria.
Key inclusion criteria (3 listed)
- At least six maxillary and mandibular anterior teeth caries-free. Without restorations on the labial surfaces. The central incisors should be C2 or darker according to a value-oriented shade guide (Vita Lumin).
- -
Key exclusion criteria (3 listed)
- Pre-existing anterior restorations. Pregnant/lactating. Severe internal tooth discoloration (tetracycline stains, fluorosis, pulpless teeth).
- Taking any drug with anti-inflammatory and antioxidant action. Bruxism habits or any other pathology that could cause Tooth Sensbility (such as recession, dentine exposure).
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Tooth sensibility
Time frame: 1 year
1 secondary outcome
Color
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2013.
- Derived from this study: PubMed 25257824de Paula EA, Nava JA, Rosso C, Benazzi CM, Fernandes KT, Kossatz S, Loguercio AD, Reis A. In-office bleaching with a two- and seven-day intervals between clinical sessions: A randomized clinical trial on tooth sensitivity. J Dent. 2015 Apr;43(4):424-9. doi: 10.1016/j.jdent.2014.09.009. Epub 2014 Sep 23.
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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.
Eloisa A Paula, MD principal investigator
Universidade Estadual de Ponta Grossa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dentin Sensitivity, run by Universidade Estadual de Ponta Grossa 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 10 Oct 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tooth sensibility (time frame: 1 year). 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 NCT01959789, which also lists 1 linked publication.
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 10 Oct 2013.