Dentin SensitivityNCT05028335
Effect of 1.5% Potassium Oxalate on the Control of Tooth Sensitivity and Color Change After Home Bleaching
A study testing Carbamide Peroxide (PC) 22%) + Potassium Oxalate gel 1.5% in people with Dentin Sensitivity, run by Universidade Federal do Para at 1 site in Brazil.
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… Read more about this study
- Who is it for?
- Ages 18 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Dentin Sensitivity
- What is being tested?
- Carbamide Peroxide (PC) 22%) + Potassium Oxalate gel 1.5%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- 7 Dec 2020to 5 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Carbamide Peroxide (PC) 22%) + placebo gel, Carbamide Peroxide (PC) 22%) + Potassium Oxalate gel 1.5%
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbamide Peroxide (PC) 22%) + placebo gelOther
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%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.
| Study group | Role | What they receive |
|---|---|---|
| Group G1 | Other | Home bleaching treatment (Carbamide Peroxide (PC) 22%) + placebo gel Receives: Other: Carbamide Peroxide (PC) 22%) + placebo gel |
| Group G2 | Experimental | Home bleaching treatment (Carbamide Peroxide (PC) 22%) + 1.5% Potassium Oxalate gel Receives: Other: Carbamide Peroxide (PC) 22%) + Potassium Oxalate gel 1.5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 21 days and 1 month after the bleaching treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2021
- Study start7 Dec 2020
- Primary completion15 Apr 2021
- Study completion5 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dentin SensitivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Para
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cecy Martins Silva, Universidade Federal do Para
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05028335
- Sponsor's protocol ID
- UFPara-0010
- Status last verified
- Dec 2024
- First submitted
- 24 Aug 2021
- Last updated
- 10 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05028335
- Acronym / sponsor ID
- UFPara-0010
- Conditions
- Dentin Sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Universidade Federal do ParaUniversity, hospital or other
- Study start
- 7 Dec 2020 (actual)
- Primary completion
- 15 Apr 2021 (actual)
- Study completion
- 5 Jun 2021 (actual)
- First posted
- 31 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group G1 | Other | Other: Carbamide Peroxide (PC) 22%) + placebo gelHome bleaching treatment (Carbamide Peroxide (PC) 22%) + placebo gel |
| Group G2 | Experimental | Other: Carbamide Peroxide (PC) 22%) + Potassium Oxalate gel 1.5%Home bleaching treatment (Carbamide Peroxide (PC) 22%) + 1.5% Potassium Oxalate gel |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carbamide Peroxide (PC) 22%) + placebo gelApplication 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. | Other | Group G1 |
| 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. | Other | Group G2 |
Primary outcome
dentin sensitivity
Time frame: 21 days after the start of the whitening treatment
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
Time frame: 21 days and 1 month after the bleaching treatment
Color evaluation was performed using the EasyshadeAdvanced spectrophotometer (Vita-Zahnfabrik, GE, Germany), using the CIE L*a*b* system.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carbamide Peroxide (PC) 22%) + Potassium Oxalate gel 1.5% in people with Dentin Sensitivity, run by Universidade Federal do Para at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
dentin sensitivity (time frame: 21 days after the start of the whitening treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024.