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

Study Overview
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Brief Summary
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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.

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

Conditions
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Dentin Sensitivity

Intervention / Treatment
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* Other: Carbamide Peroxide (PC) 22%) + placebo gel
* Other: Carbamide Peroxide (PC) 22%) + Potassium Oxalate gel 1.5%


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 29 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group G1<br>Home bleaching treatment (Carbamide Peroxide (PC) 22%) + placebo gel | Other: Carbamide Peroxide (PC) 22%) + placebo gel<br>* 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.<br>|
| Experimental: Group G2<br>Home bleaching treatment (Carbamide Peroxide (PC) 22%) + 1.5% Potassium Oxalate gel | Other: Carbamide Peroxide (PC) 22%) + Potassium Oxalate gel 1.5%<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |