NCT03523598

Potassium Nitrate and Post-bleaching Sensitivity

Completed NA Last updated 12 August 2020

What this trial tests

NA trial testing Placebo gel + Normal Toothpaste in Medicaments Substances in Therapeutic Use in 75 participants. Completed in 1 September 2018.

Timeline

26 May 2018

Primary endpoint
1 June 2018

1 September 2018

Quick facts

Lead sponsor	Universidade Federal de Sergipe
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	75
Start date	26 May 2018
Primary completion	1 June 2018
Estimated completion	1 September 2018
Sites	1 location across Brazil

Drugs / interventions tested

• Placebo gel + Normal Toothpaste
• Placebo Gel + Potassium Nitrate Toothpaste
• Potassium Nitrate Gel + Normal Toothpaste

Conditions studied

• Medicaments Substances in Therapeutic Use — all drugs for Medicaments Substances in Therapeutic Use →

Sponsor

Universidade Federal de Sergipe — full company profile →

Who can join

Adults 18 to 29, any sex, with Medicaments Substances in Therapeutic Use. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.