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Completed

NCT Number: NCT02463552

Naproxen on Tooth Sensitivity Caused by In-office Bleaching

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.

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Key information

Conditions

Toothache Facial Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomatognathic Diseases Tooth Bleaching Tooth Diseases

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade Federal de Sergipe

Aracaju, Sergipe, 49060100, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Naproxen

Drug

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

Primary outcomes

  1. Risk to Tooth sensitivity - during procedure

    Time frame: During the bleaching procedure

    The 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 outcomes

  1. Level of tooth sensitivity - during procedure

    Time frame: During the bleaching procedure

    The 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.

  2. Risk of tooth sensitivity - after procedure

    Time frame: 24 hours after bleaching prcedure

    The 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.

  3. Level of tooth sensitivity - after procedure

    Time frame: 24 hours after bleaching prcedure

    The 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 outcomes

  1. Efficacy of bleaching

    Time frame: 7 days after bleaching procedure

    A spectrophotometer will be used to assess the color alteration, while the parameter "L", "a" and "b" will be recorded.

Sponsors and collaborators

Lead sponsor

Universidade Federal de Sergipe

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 4, 2015
Registry last updated
Oct 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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