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

NCT05028335 | Completed

• 1 other identifier: UFPara-0010
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Group G1

OTHER

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

Other: Carbamide Peroxide (PC) 22%) + placebo gel

Group G2

EXPERIMENTAL

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

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

Interventions

Carbamide Peroxide (PC) 22%) + placebo gel 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 G1

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

Group G2

Eligibility Criteria

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

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal do Para: lead

Study Sites (1)

Federal University of Pará

Belém, Pará, 66075-110, Brazil

Location

MeSH Terms

Conditions

Dentin Sensitivity

Interventions

Carbamide Peroxide

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Peroxides; Oxides; Anions; Ions; Electrolytes; Inorganic Chemicals; Reactive Oxygen Species; Free Radicals; Oxygen Compounds; Urea; Amides; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical professor

Study Record Dates

• First Submitted: August 24, 2021
• First Posted: August 31, 2021
• Study Start: December 7, 2020
• Primary Completion: April 15, 2021
• Study Completion: June 5, 2021
• Last Updated: December 10, 2024

Record last verified: 2024-12

Locations

BR (1)