Potassium Nitrate and Post-bleaching Sensitivity

NCT03523598 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2020-08-12

No results posted yet for this study

Summary

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 and using different types of potassium nitrate. Materials and Methods: Seventy five 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 the potassium nitrate 2% or placebo gel application on vestibular surface and Toothpaste 15 days before start the bleaching procedure (group 1: placebo gel + Colgate toothpaste; Group 2: Placebo gel + Nitrate toothpaste Sensodyne and Group 3: Potassium Nitrate + Colgate toothpaste). 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 Vita Guide scale at the end of the last 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 and color shade will be subjected to the Friedman, Wilcoxon (α = 0.05). If necessary, multiple comparation will be done using Tukey's test.

Conditions

  • Medicaments Substances in Therapeutic Use

Interventions

OTHER

Placebo gel + Normal Toothpaste

* 15 days before and during the period of bleaching sessions: Tooth paste used will be normal (Colgate). * 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 application on vestibular surface, for 10 minutes. * Gingival dam will be performed using a fluid resin. * A 35% hydrogen peroxide based bleaching agent will applied on the vestibular surface of teeth, remaining for 40 minutes.

OTHER

Placebo Gel + Potassium Nitrate Toothpaste

* 15 days before and during the period of bleaching sessions: Tooth paste used will be normal tooth paste (Colgate). * 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 5% Potassium Nitrate gel application on vestibular surface, for 10 minutes. * Gingival dam will be performed using a fluid resin. * A 35% hydrogen peroxide based bleaching agent will applied on the vestibular surface of teeth, remaining for 40 minutes.

OTHER

Potassium Nitrate Gel + Normal Toothpaste

* 15 days before and during the period of bleaching sessions: Tooth paste used will be Potassium Nitrate containing (Sensodyne). * 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 application on vestibular surface, for 10 minutes. * Gingival dam will be performed using a fluid resin. * A 35% hydrogen peroxide based bleaching agent will applied on the vestibular surface of teeth, remaining for 40 minutes.

Sponsors & Collaborators

  • Johnny Alexandre Oliveira Tavares

    collaborator UNKNOWN
  • Universidade Federal de Sergipe

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-05-26
Primary Completion
2018-06-01
Completion
2018-09-01

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 NCT03523598 on ClinicalTrials.gov