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CompletedNCT01530217Updated Feb 9, 2012

Assessing of Tooth Sensitivity Using Ibuprofen Before in Office-tooth Bleaching

An interventional study of Ibuprofen. in Inflammation and Pulpitis, sponsored by Universidade Estadual de Ponta Grossa. Completed. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2012-02-09.

Primary conditionPulpitisRegistry: InflammationReclassifiedWhy we changed it
Registry
Inflammation — the first condition term the registry derived for this study.
ClinicalTrials.gg
Pulpitis
Why
  1. Inflammation is a broad heading, used only when no more specific condition is named.
  2. The study's listed conditions name Pulpitis.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Universidade Estadual de Ponta Grossa · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Inflammation
  • Pulpitis

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Keywords

  • Analgesics
  • Ibuprofen
  • Inflammation
  • Tooth Bleaching
03

In context

Pulpitis Reclassified

316 studies on the registry are indexed under Pulpitis; 90 are open to participants now.

This study's enrollment of 30 is below the median of 64 across 288 interventional studies indexed under Pulpitis.

Browse Pulpitis studies →

Lead sponsor

Universidade Estadual de Ponta Grossa is the lead sponsor of 8 studies on the registry; none are open to participants now.

Compared within Pulpitis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Inflammation. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
30 participants (actual)

Interventions

  • DrugIbuprofen.

    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.

    Also known as: Uniprofen / National Pharmaceutical Chemistry União S / A.

06

What researchers measure

Primary outcomes

  1. 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.

    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.

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).

    Time frame: Shade evaluation was recorded before and 30 days after the bleaching treatment.

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 9, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01530217
Lead sponsor
Universidade Estadual de Ponta Grossa
Collaborators
Fundação Araucária
Responsible party
Alessandra Reis (Doctor. Adjunctive Professors. School of Dentistry. State University of Ponta Grossa, Ponta Grossa, Paraná, Brazil., Universidade Estadual de Ponta Grossa) — Principal investigator
First posted
Feb 9, 2012
Start date
Mar 2011
Primary completion
Apr 2011
Completion
May 2011
Last update
Feb 9, 2012

Study contacts

Alessandra Reis, doctor
principal investigator · Universidade Estadual de Ponta Grossa

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.

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