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Potassium Oxalate and Placebo and Post-bleaching Sensitivity

NCT03065673 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2018-04-11

No results posted yet for this study

Summary

Purpose: This study will determine the effectiveness of the use of desensitivity gels prior in office bleaching 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. 10 minutes prior to bleaching procedure, patients will receive the potassium oxalate 5% desensitivity gel and placebo application on vestibular surface. 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 Classical guide scale. 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

Interventions

PROCEDURE

Potassium oxalate 5% gel

* Teeth will be cleaned using rubber cups associated to pumice and water * Relative isolation with roller cotton will be done; * Prior to each bleaching session, the patients will receive the potassium OXALATE 5% * Gingival dam will be performed using a fluid resin (Top Dam, FGM, Brazil) desensitivity gel application on vestibular surface, for 10 minutes. * A 35% hydrogen peroxide based bleaching agent will be mixed and applied on the vestibular surface of teeth, remaining for 40 minutes.

PROCEDURE

Placebo gel

* Teeth will be cleaned using rubber cups associated to pumice and water * Relative isolation with roller cotton will be done; * Prior to each bleaching session, the patients will receive the placebo gel * Gingival dam will be performed using a fluid resin (Top Dam, FGM, Brazil) desensitivity gel application on vestibular surface, for 10 minutes. * A 35% hydrogen peroxide based bleaching agent will be mixed and applied on the vestibular surface of teeth, remaining for 40 minutes.

Sponsors & Collaborators

  • Flavia Pardo Salata Nahsan

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-03-01
Primary Completion
2018-03-30
Completion
2018-03-30

Countries

  • Brazil

Study Locations

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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 NCT03065673 on ClinicalTrials.gov