Potassium Nitrate and Post-bleaching Sensitivity

NCT03523598 | Completed

• 1 other identifier: UFSergipe.
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Risk to the tooth sensitivity (VAS)

  The tooth sensitivity will be assessed using a Visual analogue (VAS) scale. 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 treatment

• Level of tooth sensitivity (VRS)

  During the bleaching treatment

• 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 (3)

Placebo gel + Normal Toothpaste

PLACEBO COMPARATOR

The patient will receive the application of placebo gel on vestibular surface teeth, for 10 minutes and will use the normal toothpaste (Colgate).

Other: Placebo gel + Normal Toothpaste

Placebo Gel + Potassium Nitrate Toothpaste

EXPERIMENTAL

The patient will receive the application of placebo gel on vestibular surface teeth, for 10 minutes and will use the Potassium nitrate toothpaste (Sensodyne).

Other: Placebo Gel + Potassium Nitrate Toothpaste

Potassium Nitrate Gel + Normal Toothpaste

EXPERIMENTAL

The patient will receive the application of 5% Potassium nitrategel on vestibular surface teeth, for 10 minutes and will use the normal toothpaste (Colgate).

Other: Potassium Nitrate Gel + Normal Toothpaste

Interventions

Placebo gel + Normal Toothpaste OTHER

* 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.

Placebo gel + Normal Toothpaste

Placebo Gel + Potassium Nitrate Toothpaste OTHER

* 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.

Placebo Gel + Potassium Nitrate Toothpaste

Potassium Nitrate Gel + Normal Toothpaste OTHER

* 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.

Potassium Nitrate Gel + Normal Toothpaste

Eligibility Criteria

• Age: 18 Years - 29 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients included in this clinical trial will be between 18 and 29 years old with good oral health;
• All anterior tooth healthy
• To agree with TCLE (Term of Free and Informed Consent).
• Only patients presenting all six upper anterior teeth with shade mismatching with 2.5 M2 (VitaClassicalscale, Vita-Zahnfabrik, Bad Sackingen, Germany).

You may not qualify if:

• Patients with any of the six upper anterior teeth with caries
• Restoration in anterior tooth, severe discoloration (e.g., stains caused by tetracycline), enamel hypoplasia, gingival recession, dentin exposure, pulpitis, or endodontics will be excluded.
• Participants submitted to previous bleaching procedures
• Presenting prior tooth sensitivity
• known allergy to any component of medication used in the study
• being pregnant or breastfeeding.

Sponsors & Collaborators

• Universidade Federal de Sergipe: lead
• Johnny Alexandre Oliveira Tavares: collaborator

Study Sites (1)

Federal University of Sergipe

Aracaju, Sergipe, 49060-108, Brazil

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Triple (Participant, Investigator, Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: April 9, 2018
• First Posted: May 14, 2018
• Study Start: May 26, 2018
• Primary Completion: June 1, 2018
• Study Completion: September 1, 2018
• Last Updated: August 12, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)