Back to resultsEffect of 1.5% Potassium Oxalate on the Control of Tooth Sensitivity and Color Change After Home Bleaching
Primary Purpose
Dentin Sensitivity
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Carbamide Peroxide (PC) 22%) + placebo gel
Carbamide Peroxide (PC) 22%) + Potassium Oxalate gel 1.5%
Sponsored by
About this trial
This is an interventional treatment trial for Dentin Sensitivity
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.
Sites / Locations
- Federal University of Pará
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Group G1
Group G2
Arm Description
Home bleaching treatment (Carbamide Peroxide (PC) 22%) + placebo gel
Home bleaching treatment (Carbamide Peroxide (PC) 22%) + 1.5% Potassium Oxalate gel
Outcomes
Primary Outcome Measures
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.
dental color assessment
Color evaluation was performed using the EasyshadeAdvanced spectrophotometer (Vita-Zahnfabrik, GE, Germany), using the CIE L*a*b* system.
Secondary Outcome Measures
Full Information
NCT ID
NCT05028335
First Posted
August 24, 2021
Last Updated
August 24, 2021
Sponsor
Universidade Federal do Para
1. Study Identification
Unique Protocol Identification Number
NCT05028335
Brief Title
Effect of 1.5% Potassium Oxalate on the Control of Tooth Sensitivity and Color Change After Home Bleaching
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
December 7, 2020 (Actual)
Primary Completion Date
April 15, 2021 (Actual)
Study Completion Date
June 5, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Para
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dentin Sensitivity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group G1
Arm Type
Other
Arm Description
Home bleaching treatment (Carbamide Peroxide (PC) 22%) + placebo gel
Arm Title
Group G2
Arm Type
Experimental
Arm Description
Home bleaching treatment (Carbamide Peroxide (PC) 22%) + 1.5% Potassium Oxalate gel
Intervention Type
Other
Intervention Name(s)
Carbamide Peroxide (PC) 22%) + placebo gel
Intervention Description
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
Intervention Name(s)
Carbamide Peroxide (PC) 22%) + Potassium Oxalate gel 1.5%
Intervention Description
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.
Primary Outcome Measure Information:
Title
dentin sensitivity
Description
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.
Time Frame
21 days after the start of the whitening treatment
Title
dental color assessment
Description
Color evaluation was performed using the EasyshadeAdvanced spectrophotometer (Vita-Zahnfabrik, GE, Germany), using the CIE L*a*b* system.
Time Frame
21 days and 1 month after the bleaching treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Federal University of Pará
City
Belém
State/Province
Pará
ZIP/Postal Code
66075-110
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Effect of 1.5% Potassium Oxalate on the Control of Tooth Sensitivity and Color Change After Home Bleaching
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