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

NCT ID: NCT05028335

Last Updated: 2024-12-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-07
• Study Completion Date: 2021-06-05

Brief 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.

Conditions

Dentin Sensitivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group G1

Home bleaching treatment (Carbamide Peroxide (PC) 22%) + placebo gel

Group Type: OTHER

Carbamide Peroxide (PC) 22%) + placebo gel

Intervention Type: OTHER

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.

Group G2

Home bleaching treatment (Carbamide Peroxide (PC) 22%) + 1.5% Potassium Oxalate gel

Group Type: EXPERIMENTAL

Carbamide Peroxide (PC) 22%) + Potassium Oxalate gel 1.5%

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 29 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidade Federal do Para

OTHER

Sponsor Role: lead

Responsible Party

Cecy Martins Silva

clinical professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Federal University of Pará

Belém, Pará, Brazil

Countries

Brazil

Other Identifiers

UFPara-0010

Identifier Type: -

Identifier Source: org_study_id