Etodolac and Post-bleaching Sensitivity

NCT02881619 | Completed Phase 4

• 1 other identifier: UFS
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

Objectives: This study will determine the effectiveness of preemptive administration of etodolac on risk and intensity of tooth sensitivity caused by in-office bleaching using 35% hydrogen peroxide. Materials and Methods: Fifty patients will be selected for this triple-blind, randomized, cross-over, placebo-controlled clinical trial. Etodolac (400 mg) or placebo will be administrated in a single-dose 1 hour 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 before, during and 24 hours after 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 McNemar's test. Data on the sensitivity level for both scales and color shade will be subjected to the Friedman, Wilcoxon and Mann-Whitney tests, respectively (α = 0.05).

Conditions

Medicaments Substances in Therapeutic Use

Keywords

Tooth bleaching

Outcome Measures

Primary Outcomes (1)

• Risk to the tooth sensitivity

  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.

  During the bleaching treatment.

Secondary Outcomes (3)

• Level of tooth sensitivity - during procedure

  During the Bleaching procedure

• Risk after tooth sensitivity - after the procedure

  24 hours after the Bleaching procedure

• Level of tooth sensitivity - after the procedure

  24 hours after the Bleaching procedure

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo - (inert content)

Drug: Placebo

Experimental -

EXPERIMENTAL

400 mg of NAISE etodolac

Drug: Etodolac

Interventions

Etodolac DRUG

The patient will receive a single-dose of Etodolac (400 mg) one hour before the bleaching procedure.

Experimental -

Placebo DRUG

The patient will receive a single-dose of placebo one hour before the bleaching procedure.

Placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients included in this clinical trial will be at least 18 years old with good oral health. . Only patients presenting all six upper anterior teeth with shade mismatching with 2.5 M2 (Vita Bleachguide 3D-Master scale, Vita-Zahnfabrik, Bad Sackingen, Germany) or darker will be included.

You may not qualify if:

• Patients with any of the six upper anterior teeth with caries, restoration, severe discoloration (e.g., stains caused by tetracycline), enamel hypoplasia, gingival recession, dentin exposure, pulpitis, or endodontics will be excluded. Participants submitted to previous bleaching procedures, presenting prior tooth sensitivity, known allergy to any component of medication used in the study, pregnant or breastfeeding will be also excluded.

Sponsors & Collaborators

• Flavia Pardo Salata Nahsan: lead

MeSH Terms

Interventions

Etodolac

Intervention Hierarchy (Ancestors)

Indoleacetic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Flavia Pardo Salata Nahsan

  Universidade Federal de Sergipe

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: August 4, 2016
• First Posted: August 29, 2016
• Study Start: November 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: August 29, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share