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Naproxen on Tooth Sensitivity Caused by In-office Bleaching

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ClinicalTrials.gov Identifier: NCT02463552
Recruitment Status : Completed
First Posted : June 4, 2015
Last Update Posted : October 26, 2016
Sponsor:
Information provided by (Responsible Party):
André Luis Faria e Silva, Universidade Federal de Sergipe

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.

Condition or disease Intervention/treatment Phase
Toothache Tooth Bleaching Drug: Naproxen Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Rior Use of Naproxen on Tooth Sensitivity Reduction After In-office Bleaching: Randomized Clinical Trial
Study Start Date : May 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Naproxen
The patient will receive a single-dose of Naproxen (500 mg) one hour before the bleaching procedure.

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




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02463552


Locations
Brazil
Universidade Federal de Sergipe
Aracaju, SE, Brazil, 49060100
Sponsors and Collaborators
Universidade Federal de Sergipe

Responsible Party: André Luis Faria e Silva, Dr., Universidade Federal de Sergipe
ClinicalTrials.gov Identifier: NCT02463552     History of Changes
Other Study ID Numbers: UFSergipe
First Posted: June 4, 2015    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Dentin Sensitivity
Toothache
Tooth Diseases
Stomatognathic Diseases
Facial Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Naproxen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action