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Piroxicam-beta-Cyclodextrin on Tooth Sensitivity Caused by In-office Bleaching

NCT03153657 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2017-11-09

No results posted yet for this study

Summary

Objectives: This study aims to evaluate the effectiveness of preemptive administration of non-steroidal anti-inflammatory Piroxicam-beta-Cyclodextrin on risk and level of tooth sensitivity caused by in-office bleaching procedures using 35% hydrogen peroxide.

Fifty patients will be selected for this triple-blind, randomized, cross-over, placebo-controlled clinical trial. Piroxicam-beta-Cyclodextrin (200 mg) or placebo will be administrated in a single-dose thirty minutes prior to bleaching procedure. The whitening treatment with 35% hydrogen peroxide will be carried out in two sessions with a 7-day interval. Tooth sensitivity will be assessed Immediately before bleaching agent removal and up to 24 hours after each session the procedure using analog visual and verbal scales. Color alteration will be assessed by a bleach guide scale 7 days after each session. Relative risk to sensitivity will be calculated and adjusted by session; while comparison of overall risk will performed by Fisher's exact test. Data on the sensitivity level for both scales and color shade will be subjected to the Mann-Whitney and Friedman tests, respectively (α = 0.05).

Conditions

  • Tooth Sensitivity
  • Toothache

Interventions

DRUG

Piroxicam-Beta-Cyclodextrin

The patients will receive a single-dose of Piroxicam-Beta-Cyclodextrin (20 mg) thirty minutes before the bleaching procedure.

DRUG

Placebo

The patients will receive a single-dose of placebo with the same presentation of the experimental drug thirty minutes before the bleaching procedure.

Sponsors & Collaborators

  • Universidade Federal de Sergipe

    lead OTHER

Principal Investigators

  • Aline C Peixoto · Universidade Federal de Sergipe

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-12-13
Primary Completion
2017-04-30
Completion
2017-05-31

Countries

  • Brazil

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03153657 on ClinicalTrials.gov