InflammationNCT01530217
Assessing of Tooth Sensitivity Using Ibuprofen Before in Office-tooth Bleaching
A study testing Ibuprofen. in people with Inflammation and Pulpitis, run by Universidade Estadual de Ponta Grossa.
Trial summary
Ibuprofen has been recognized as anti-inflammatory and analgesic. The purpose of this study is to determine the effect of ibuprofen 400 mg on tooth sensitivity (TS) caused by in-office bleaching. Methods: 30 health adults who received either placebo or ibuprofen. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Inflammation, Pulpitis
- What is being tested?
- Ibuprofen.
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Mar 2011to May 2011
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients included in this clinical trial were:
- at least 18 years old.
- had good general and oral health.
- the participants should have eight caries-free maxillary and jaw anterior teeth and without restorations on the labial surfaces.
- the central incisors should be shade C2 or darker.
Who cannot join
- participants that had undergone tooth-whitening procedures.
- presenting anterior restorations.
- pregnant/lactating.
- with severe internal tooth discoloration (tetracycline stains, fluorosis, pulpless teeth).
- taking any kind of medicine, bruxism habits or any other pathology that could cause sensitivity (such as recession, dentine exposure).
- participants that reported some earlier or present health problems in stomach, heart, kidney and liver, or participants using any continuous drug with anti-inflammatory and antioxidant action were excluded from the study.
About this study
Official title: Assessing of Tooth Sensitivity Using Ibuprofen Before in Office-tooth Bleaching: a Randomized, Triple-blind Clinical Trial
Ibuprofen has been recognized as anti-inflammatory and analgesic. The purpose of this study is to determine the effect of ibuprofen 400 mg on tooth sensitivity (TS) caused by in-office bleaching.
Methods: 30 health adults who received either placebo or ibuprofen. The drugs were administered 1 hour prior to the bleaching and will be prescribed 5 doses every 8 hours during 48 hours. For bleaching will be used 35% hydrogen peroxide gel. The tooth sensitivity will be recorded for up and lower arc on two scales: VAS (visual analogic scale) and 0-4. The shade evaluation will be performed before and 30 days after bleaching with visual shade guide and spectrophotometer.
Read the detailed description
Background: Ibuprofen has been recognized as anti-inflammatory and analgesic. The purpose of this study was to determine the effect of ibuprofen 400 mg on tooth sensitivity (TS) caused by in-office bleaching.
Methods: A triple-blind, parallel design, randomized clinical trial will be conducted on 30 health adults who received either placebo or ibuprofen. The drugs will be administered 1 hour prior to the bleaching and a every eight hours during 48 hours. For bleaching used 35% hydrogen peroxide gel. The TS will be recorded for up and lower arc on two scales: VAS and 0-4. The shade evaluation will be performed before and 30 days after bleaching with visual shade guide and spectrophotometer. The % of patients that reported TS at least once during treatment and the TS intensity will be evaluated by Fisher's and Mann-Whitney tests, respectively. The color changes will be evaluated by repeated measures ANOVA.
- Conditions
- Inflammation, Pulpitis
- Being tested
- Ibuprofen.
- Keywords
- Analgesics, Ibuprofen, Inflammation, Tooth Bleaching
- Medical subject headings
- Inflammation, Pulpitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ibuprofen.Drug
Also called Uniprofen / National Pharmaceutical Chemistry União S / A.
Ibuprofen Group will be receive a dose of non-steroidal antiinflammatory drug ibuprofen 400 mg. All the participants will be watched to ensure that they took the drugs 1 hour prior to treatment. A second dose of ibuprofen (400 mg), will be administered a every 8 hours after the first dose during 48 hours.
What is being measured
The primary outcome is the main question the study is designed to answer.
Tooth sensitivity evaluation
Patients will be distributed in two groups: Group 1 - Control Group will receive placebo. Group 2 - Ibuprofen will receive not selective anti-inflammatory (Ibuprofen 400 mg). All of the drugs will be administered one hour before the bleaching treatment. Evaluation of Dental Sensitivity Level: the effect of the product will be evaluated up to 1 Hour, 24 and 48 hours after the tooth bleaching, using a verbal scale of 5 points and a Visual Analogue Scale (VAS) will be used.
Measured: Sensitivity during the treatment and until 48 hours after bleaching. The tooth sensitivity will be evaluated only this period because the literature appoint dates in this time.
Secondary outcomes (1)
Shade evaluation
Shade evaluation was recorded using two methods: the subjective evaluation using a shade guide (Vita Lumin, Vita Zahnfabrik, Bad Säckingen, Germany) and an objective evaluation using the spectrophotometer (Easyshade, Vident, Brea, CA, USA).
Measured: Shade evaluation was recorded before and 30 days after the bleaching treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2012 (estimated)
- Study startMar 2011
- Primary completionApr 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual de Ponta Grossa
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação Araucária
- Responsible party
- Principal investigator, Alessandra Reis, Universidade Estadual de Ponta Grossa
- Investigators
- Alessandra Reis, doctor, Principal investigator, Universidade Estadual de Ponta Grossa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01530217
- Sponsor's protocol ID
- 17836/2010
- Status last verified
- Feb 2012
- First submitted
- 13 Dec 2011
- Last updated
- 9 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing of Tooth Sensitivity Using Ibuprofen Before in Office-tooth Bleaching: a Randomized, Triple-blind Clinical Trial
- ClinicalTrials.gov ID
- NCT01530217
- Acronym / sponsor ID
- 17836/2010
- Conditions
- Inflammation, Pulpitis
- Keywords
- Analgesics, Ibuprofen, Inflammation, Tooth Bleaching
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universidade Estadual de Ponta GrossaUniversity, hospital or other
- Collaborators
- Fundação Araucária
- Study start
- Mar 2011
- Primary completion
- Apr 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 9 Feb 2012 (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.
Ibuprofen has been recognized as anti-inflammatory and analgesic. The purpose of this study is to determine the effect of ibuprofen 400 mg on tooth sensitivity (TS) caused by in-office bleaching.
Methods: 30 health adults who received either placebo or ibuprofen. The drugs were administered 1 hour prior to the bleaching and will be prescribed 5 doses every 8 hours during 48 hours. For bleaching will be used 35% hydrogen peroxide gel. The tooth sensitivity will be recorded for up and lower arc on two scales: VAS (visual analogic scale) and 0-4. The shade evaluation will be performed before and 30 days after bleaching with visual shade guide and spectrophotometer.
Detailed description
Background: Ibuprofen has been recognized as anti-inflammatory and analgesic. The purpose of this study was to determine the effect of ibuprofen 400 mg on tooth sensitivity (TS) caused by in-office bleaching.
Methods: A triple-blind, parallel design, randomized clinical trial will be conducted on 30 health adults who received either placebo or ibuprofen. The drugs will be administered 1 hour prior to the bleaching and a every eight hours during 48 hours. For bleaching used 35% hydrogen peroxide gel. The TS will be recorded for up and lower arc on two scales: VAS and 0-4. The shade evaluation will be performed before and 30 days after bleaching with visual shade guide and spectrophotometer. The % of patients that reported TS at least once during treatment and the TS intensity will be evaluated by Fisher's and Mann-Whitney tests, respectively. The color changes will be evaluated by repeated measures ANOVA.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patients included in this clinical trial were:
- at least 18 years old.
- had good general and oral health.
- the participants should have eight caries-free maxillary and jaw anterior teeth and without restorations on the labial surfaces.
- the central incisors should be shade C2 or darker.
Key exclusion criteria (6 listed)
- participants that had undergone tooth-whitening procedures.
- presenting anterior restorations.
- pregnant/lactating.
- with severe internal tooth discoloration (tetracycline stains, fluorosis, pulpless teeth).
- taking any kind of medicine, bruxism habits or any other pathology that could cause sensitivity (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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ibuprofen.Also: Uniprofen / National Pharmaceutical Chemistry União S / A.Ibuprofen Group will be receive a dose of non-steroidal antiinflammatory drug ibuprofen 400 mg. All the participants will be watched to ensure that they took the drugs 1 hour prior to treatment. A second dose of ibuprofen (400 mg), will be administered a every 8 hours after the first dose during 48 hours. | Drug | – |
Primary outcome
Tooth sensitivity evaluation
Time frame: Sensitivity during the treatment and until 48 hours after bleaching. The tooth sensitivity will be evaluated only this period because the literature appoint dates in this time.
Patients will be distributed in two groups: Group 1 - Control Group will receive placebo. Group 2 - Ibuprofen will receive not selective anti-inflammatory (Ibuprofen 400 mg). All of the drugs will be administered one hour before the bleaching treatment. Evaluation of Dental Sensitivity Level: the effect of the product will be evaluated up to 1 Hour, 24 and 48 hours after the tooth bleaching, using a verbal scale of 5 points and a Visual Analogue Scale (VAS) will be used.
1 secondary outcome
Shade evaluation
Time frame: Shade evaluation was recorded before and 30 days after the bleaching treatment.
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 9 Feb 2012.
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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.
Alessandra Reis, doctor principal investigator
Universidade Estadual de Ponta Grossa
Questions about this trial
What is this clinical trial studying?
A study testing Ibuprofen. in people with Inflammation and Pulpitis, run by Universidade Estadual de Ponta Grossa.
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 5 inclusion and 6 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 9 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
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 sensitivity evaluation (time frame: Sensitivity during the treatment and until 48 hours after bleaching. The tooth sensitivity will be evaluated only this period because the literature appoint dates in this time.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Feb 2012.