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Naproxen on Tooth Sensitivity Caused by In-office Bleaching

Primary Purpose

Toothache, Tooth Bleaching

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Naproxen
Sponsored by
Universidade Federal de Sergipe
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Toothache

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Universidade Federal de Sergipe

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Naproxen

Arm Description

Outcomes

Primary Outcome Measures

Risk to Tooth sensitivity - during 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

Level of tooth sensitivity - during 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.
Risk of tooth sensitivity - after 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.
Level of tooth sensitivity - after 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.

Full Information

First Posted
May 29, 2015
Last Updated
October 24, 2016
Sponsor
Universidade Federal de Sergipe
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1. Study Identification

Unique Protocol Identification Number
NCT02463552
Brief Title
Naproxen on Tooth Sensitivity Caused by In-office Bleaching
Official Title
Rior Use of Naproxen on Tooth Sensitivity Reduction After In-office Bleaching: Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Sergipe

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Toothache, Tooth Bleaching

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Naproxen
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Naproxen
Intervention Description
The patient will receive a single-dose of Naproxen (500 mg) one hour before the bleaching procedure.
Primary Outcome Measure Information:
Title
Risk to Tooth sensitivity - during procedure
Description
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.
Time Frame
During the bleaching procedure
Secondary Outcome Measure Information:
Title
Level of tooth sensitivity - during procedure
Description
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.
Time Frame
During the bleaching procedure
Title
Risk of tooth sensitivity - after procedure
Description
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.
Time Frame
24 hours after bleaching prcedure
Title
Level of tooth sensitivity - after procedure
Description
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.
Time Frame
24 hours after bleaching prcedure
Other Pre-specified Outcome Measures:
Title
Efficacy of bleaching
Description
A spectrophotometer will be used to assess the color alteration, while the parameter "L", "a" and "b" will be recorded.
Time Frame
7 days after bleaching procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
Universidade Federal de Sergipe
City
Aracaju
State/Province
SE
ZIP/Postal Code
49060100
Country
Brazil

12. IPD Sharing Statement

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Naproxen on Tooth Sensitivity Caused by In-office Bleaching

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