Potassium Oxalate and Placebo and Post-bleaching Sensitivity

NCT03065673 | Completed

• 1 other identifier: UFSHU
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Tooth bleaching; Tooth sensitivity

Outcome Measures

Primary Outcomes (2)

• Risk to the tooth sensitivity (VAS)

  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 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.

• Risk to the tooth sensitivity (VRS)

  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 (7)

• Level of tooth sensitivity (VAS)

  During the Bleaching procedure

• Level of tooth sensitivity (VRS)

  During the Bleaching procedure

• Risk after tooth sensitivity- after the procedure (VAS)

  24 hours after the Bleaching procedure

• Risk after tooth sensitivity- after the procedure (VRS)

  24 hours after the Bleaching procedure

• Level of tooth sensitivity - after the procedure (VAS)

  24 hours after the Bleaching procedure

Study Arms (2)

Potassium Oxalate 5% gel

ACTIVE COMPARATOR

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

Procedure: Potassium oxalate 5% gel

Placebo gel

PLACEBO COMPARATOR

The patient will receive the application placebo gel on vestibular surface teeth, for 10 minutes.

Procedure: Placebo gel

Interventions

Potassium oxalate 5% gel PROCEDURE

* 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.

Potassium Oxalate 5% gel

Placebo gel PROCEDURE

* 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.

Placebo gel

Eligibility Criteria

• Age: 18 Years - 35 Years
• 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

• Flavia Pardo Salata Nahsan: lead

Study Sites (1)

Flavia Pardo Salata Nahsan

Aracaju, Sergipe, 49060-100, Brazil

Location

MeSH Terms

Conditions

Dentin Sensitivity

Interventions

Oxalic Acid; Gels

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Oxalates; Dicarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

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: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 16, 2017
• First Posted: February 28, 2017
• Study Start: March 1, 2018
• Primary Completion: March 30, 2018
• Study Completion: March 30, 2018
• Last Updated: April 11, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)