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Naproxen on Tooth Sensitivity Caused by In-office Bleaching

Rior Use of Naproxen on Tooth Sensitivity Reduction After In-office Bleaching: Randomized Clinical Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02463552
Enrollment
50
Registered
2015-06-04
Start date
2015-05-31
Completion date
2016-10-31
Last updated
2016-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Toothache, Tooth Bleaching

Brief summary

This study aims to evaluate the effects of prior use of non-steroidal anti-inflammatory Naproxen on risk and level of tooth sensitivity caused by in-office bleaching procedures.

Interventions

DRUGNaproxen

The patient will receive a single-dose of Naproxen (500 mg) one hour before the bleaching procedure.

Sponsors

Universidade Federal de Sergipe
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes

Inclusion criteria

* At least 18 years old patients of both genders presenting good general/oral health; * All maxillary anterior teeth presenting shade equal or darker than 2M2 at Vita bleachguide guide (Vita-Zahnfabrik, Germany); * Signed the form accepting to participate of this study.

Exclusion criteria

* Presence of caries lesions, restorations and/or endodontic treatment at any maxillary anterior teeth. * Undergone tooth-whitening procedures; * Pregnant/lactating; * Presence of periodontal diseases; * Presence of severe tooth discoloration by tetracycline stains or fluorosis; * Any kind of medicine, bruxism habits or any other pathology that can cause sensitivity (such as recession, dentin exposure); * Continuous use of drugs with anti-inflammatory actions; * Presence of tooth hypersensitivity at baseline measurement; * Any known adverse effects caused by Naproxen; * Non-attendance to any session of evaluation or bleaching.

Design outcomes

Primary

MeasureTime frameDescription
Risk to Tooth sensitivity - during procedureDuring the bleaching procedureThe tooth sensitivity will be evaluated using a 5-point Verbal rating scale (VRS), where 0 = none, 1 = mild, 2 = moderate, 3 = considerable and 4 = severe. Score different from 0 will determine presence of sensitivity. The risk of tooth sensitivity will be determined by relative risk assessed by ratio between absolute risk of experimental condition by those observed in control. The 95% confidence interval will be calculated.

Secondary

MeasureTime frameDescription
Level of tooth sensitivity - during procedureDuring the bleaching procedureThe tooth sensitivity will be evaluated using a 5-point Verbal rating scale (VRS), where 0 = none, 1 = mild, 2 = moderate, 3 = considerable and 4 = severe.
Risk of tooth sensitivity - after procedure24 hours after bleaching prcedureThe tooth sensitivity will be evaluated using a 5-point Verbal rating scale (VRS), where 0 = none, 1 = mild, 2 = moderate, 3 = considerable and 4 = severe. Score different from 0 will determine presence of sensitivity. The risk of tooth sensitivity will be determined by relative risk assessed by ratio between absolute risk of experimental condition by those observed in control. The 95% confidence interval will be calculated.
Level of tooth sensitivity - after procedure24 hours after bleaching prcedureThe tooth sensitivity will be evaluated using a 5-point Verbal rating scale (VRS), where 0 = none, 1 = mild, 2 = moderate, 3 = considerable and 4 = severe.

Other

MeasureTime frameDescription
Efficacy of bleaching7 days after bleaching procedureA spectrophotometer will be used to assess the color alteration, while the parameter L, a and b will be recorded.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026