Potassium Oxalate and Potassium Nitrate and Post-bleaching Sensitivity

NCT02941653 | Completed

• 1 other identifier: UFSergipeHU
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives: 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: Fourty seven 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% and potassium oxalate 5% desensitivity gel 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 bleach guide scale and Vita Easy shade spectrophotometer 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

Outcome Measures

Primary Outcomes (1)

• Risk to the tooth sensitivity

  The tooth sensitivity will be assessed using a Visual analogue (VAS) and verbal scales. VAS consisted of a 10-cm scale 0 (no sensitivity) 10 (unbearable sensitivity). A slightly air-stream will be applied over the buccal surfaces of the central incisors, and the patients will record their sensitivity perception by pointing with a pen on the scale. The distance between the marking and the border of scale, relative to the absence of sensitivity will be measured. The measurements will be scored according to the distance from 0, using a digital caliper. 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 (4)

• Level of tooth sensitivity

  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

• Bleaching Effectiveness

  Before the bleaching procedures and 7 days after this

Study Arms (2)

Control: Potassium Nitrate 2% gel

ACTIVE COMPARATOR

The patient will receive the application of potassium nitrate 2% gel on vestibular surface teeth, for 10 minutes.

Device: Potassium nitrate 2% gel

Intervention: Potassium Oxalate 5% gel

EXPERIMENTAL

The patient will receive the application of potassium oxalate 5% gel on vestibular surface teeth, for 10 minutes.

Device: Potassium oxalate 5% gel

Interventions

Potassium nitrate 2% gel DEVICE

* 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 nitrate 2% desensitivity gel application on vestibular surface, for 10 minutes. * Gingival dam will be performed using a fluid resin (Top Dam, FGM, Brazil) * A 35% hydrogen peroxide based bleaching agent will be mixed and applied on the vestibular surface of teeth, remaining for 40 minutes.

Control: Potassium Nitrate 2% gel

Potassium oxalate 5% gel DEVICE

* 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.

Intervention: Potassium Oxalate 5% gel

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

Sponsors & Collaborators

• Universidade Federal de Sergipe: lead

Study Sites (1)

Flavia Pardo Salata Nahsan

Aracaju, Sergipe, 49060-100, Brazil

Location

Study Officials

• Flavia Pardo S Nahsan, PhD

  Universidade Federal de Sergipe

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 19, 2016
• First Posted: October 21, 2016
• Study Start: November 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: October 1, 2017
• Last Updated: April 11, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)