Effect of 1.5% Potassium Oxalate on the Control of Tooth Sensitivity and Color Change After Home Bleaching

Dentin Sensitivity Clinical Trial

Official title:

Effect of 1.5% Potassium Oxalate on the Control of Tooth Sensitivity and Color Change After Home Bleaching: a Randomized, Placebo-controlled Clinical Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05028335
• Other study ID #: UFPara-0010
• Status: Completed
• Phase: N/A
• Start date: December 7, 2020
• Est. completion date: June 5, 2021

Study information

• Verified date: August 2021
• Source: Universidade Federal do Para
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This double-blind randomized clinical trial evaluated the effect of 1.5% potassium oxalate on pain sensitivity control and color change after home tooth whitening. It also evaluated the influence of potassium oxalate on health-related quality of life (HRQOL) and on the degree of patient satisfaction after bleaching treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 5, 2021
• Est. primary completion date: April 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 29 Years

Eligibility

Inclusion Criteria:

• individuals aged 18 to 29 years of both sexes with chroma greater than A2 in the upper incisors and canines, in the Vita Classical color scale;

• absence of active caries lesions

• patients who had never undergone bleaching therapy;

• good oral hygiene and no hypersensitivity to tactile and evaporative stimuli through the Visual Analog Pain Scale;

Exclusion Criteria:

• patients undergoing fixed orthodontic treatment;

• patients with darkened non-vital teeth and/or with extensive restorations in molars;

• presence of cracks or fractures;

• patients allergic to the product, with the presence of gastroesophageal disorders and with dentinal exposure in anterior and/or posterior teeth.

Related Conditions & MeSH terms

• Dentin Sensitivity
• Hypersensitivity

Intervention

Other:
• Carbamide Peroxide (PC) 22%) + placebo gel
Application of one drop of Polanight bleaching agent (SDI, SP, Brazil) on each corresponding tooth in a tray that was used for 45 minutes a day, for a period of twenty-one days. After the bleaching treatment, the participants were instructed to wash the trays under running water and dry them. The volunteers were instructed to apply a small amount of placebo gel, without active ingredient, with color, texture and odor similar to 1.5% oxalate gel (Painless, BM4, SC, Brazil) in the spaces related to the vestibular portions of the teeth trays, which were used for 10 minutes.
• Carbamide Peroxide (PC) 22%) + Potassium Oxalate gel 1.5%
Application of one drop of Polanight bleaching agent (SDI, SP, Brazil) on each corresponding tooth in a tray that was used for 45 minutes a day, for a period of twenty-one days. After the bleaching treatment, the participants were instructed to wash the trays under running water and dry them with absorbent paper. The volunteers applied a small amount of 1.5% potassium oxalate gel (Painless, BM4, SC, Brazil) in the spaces relative to the vestibular portions of the tray's teeth, which were used for 10 minutes.

Locations

Country	Name	City	State
Brazil	Federal University of Pará	Belém	Pará

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal do Para

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	dentin sensitivity	evaluation of dentinal sensitivity during treatment through a daily questionnaire, using a visual analogue scale with values from 0 to 10, with higher values indicating a worse level of pain.	21 days after the start of the whitening treatment
Primary	dental color assessment	Color evaluation was performed using the EasyshadeAdvanced spectrophotometer (Vita-Zahnfabrik, GE, Germany), using the CIE L*a*b* system.	21 days and 1 month after the bleaching treatment