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

NCT03153657 | Completed Phase 3

• 1 other identifier: Univ Federal de Sergipe
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Tooth Bleaching

Outcome Measures

Primary Outcomes (1)

• Risk to 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.

  up to 24 hours after each session. [Safety Issue: Yes]

Secondary Outcomes (1)

• Level to Tooth sensitivity

  up to 24 hours after each session.[Safety Issue: Yes

Study Arms (2)

Piroxicam-beta-Cyclodextrin

EXPERIMENTAL

Intervention: Drug Piroxicam-beta-Cyclodextrin

Drug: Piroxicam-Beta-Cyclodextrin; Drug: Placebo

Placebo

PLACEBO COMPARATOR

Intervention: Drug Placebo

Drug: Piroxicam-Beta-Cyclodextrin; Drug: Placebo

Interventions

Piroxicam-Beta-Cyclodextrin DRUG

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

Also known as: Cycladol (20mg) capsule

Piroxicam-beta-Cyclodextrin; Placebo

Placebo DRUG

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

Also known as: Starch capsule made to mimic Piroxicam-Beta-Cyclodextrin

Piroxicam-beta-Cyclodextrin; Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• At least 18 years old patients of both genders presenting good general/oral health;
• All maxillary anterior teeth presenting shade equal or darker than 2,5M2 at Vita bleachguide guide (Vita-Zahnfabrik, Germany);
• Signed the form accepting to participate of this study.

You may not qualify if:

• 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 Piroxicam-beta-Cyclodextrin;
• Non-attendance to any session of evaluation or bleaching.

Sponsors & Collaborators

• Universidade Federal de Sergipe: lead

Study Sites (1)

Hospital Universitário - Universidade Federal de Sergipe

Aracaju, Sergipe, 490000, Brazil

Location

MeSH Terms

Conditions

Dentin Sensitivity; Toothache

Interventions

piroxicam-beta-cyclodextrin; Starch

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Polysaccharides

Study Officials

• Aline C Peixoto

  Universidade Federal de Sergipe

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Triple Blind (Participant, Investigator, Outcomes Assessor)
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 14, 2017
• First Posted: May 15, 2017
• Study Start: December 13, 2016
• Primary Completion: April 1, 2017
• Study Completion: May 1, 2017
• Last Updated: November 9, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)