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

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ClinicalTrials.gov Identifier: NCT03153657
Recruitment Status : Completed
First Posted : May 15, 2017
Last Update Posted : November 9, 2017
Sponsor:
Information provided by (Responsible Party):
Aline Carvalho Peixoto, Universidade Federal de Sergipe

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).


Condition or disease Intervention/treatment Phase
Tooth Sensitivity Toothache Drug: Piroxicam-Beta-Cyclodextrin Drug: Placebo Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Triple Blind (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Preemptive Use of Piroxicam-beta-Cyclodextrin on Tooth Sensitivity Caused by In-office Bleaching: Randomized, Triple-blind, Controlled Clinical Trial
Actual Study Start Date : December 13, 2016
Actual Primary Completion Date : April 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy
Drug Information available for: Piroxicam

Arm Intervention/treatment
Experimental: Piroxicam-beta-Cyclodextrin
Intervention: Drug Piroxicam-beta-Cyclodextrin
Drug: Piroxicam-Beta-Cyclodextrin
The patients will receive a single-dose of Piroxicam-Beta-Cyclodextrin (20 mg) thirty minutes before the bleaching procedure.
Other Name: Cycladol (20mg) capsule

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.
Other Name: Starch capsule made to mimic Piroxicam-Beta-Cyclodextrin

Placebo Comparator: Placebo
Intervention: Drug Placebo
Drug: Piroxicam-Beta-Cyclodextrin
The patients will receive a single-dose of Piroxicam-Beta-Cyclodextrin (20 mg) thirty minutes before the bleaching procedure.
Other Name: Cycladol (20mg) capsule

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.
Other Name: Starch capsule made to mimic Piroxicam-Beta-Cyclodextrin




Primary Outcome Measures :
  1. Risk to Tooth sensitivity [ Time Frame: up to 24 hours after each session. [Safety Issue: Yes] ]
    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 to Tooth sensitivity [ Time Frame: up to 24 hours after each session.[Safety Issue: Yes ]
    The tooth sensitivity also will be evaluated using a analogic visual analogue (VAS) consisted of a scale 10 cm in length ranging from 0 (absence of pain) to 10 (unsupportable pain). The patient set his or her level of sensitivity by pointing on the scale corresponding to this level, while the distance from this point to the 0 border will be recorded.



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Ages Eligible for Study:   18 Years to 40 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 2,5M2 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 Piroxicam-beta-Cyclodextrin;
  • 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): NCT03153657


Locations
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Brazil
Hospital Universitário - Universidade Federal de Sergipe
Aracaju, Sergipe, Brazil, 490000
Sponsors and Collaborators
Universidade Federal de Sergipe
Investigators
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Principal Investigator: Aline C Peixoto Universidade Federal de Sergipe

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Responsible Party: Aline Carvalho Peixoto, Principal Investigator, Universidade Federal de Sergipe
ClinicalTrials.gov Identifier: NCT03153657     History of Changes
Other Study ID Numbers: Univ Federal de Sergipe
First Posted: May 15, 2017    Key Record Dates
Last Update Posted: November 9, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Aline Carvalho Peixoto, Universidade Federal de Sergipe:
Tooth Bleaching
Additional relevant MeSH terms:
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Piroxicam-beta-cyclodextrin
Betadex
Dentin Sensitivity
Toothache
Hypersensitivity
Immune System Diseases
Tooth Diseases
Stomatognathic Diseases
Facial Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Piroxicam
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
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Sequestering Agents