Effectiveness of 16% Carbamide Peroxide in Reducing Hypersensitivity During Alternate-day Home Bleaching

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-06

Study Completion Date

2025-09-01

Brief Summary

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The concentration of 16% carbamide peroxide is the highest concentration that European regulations allow for use in home whitening (Council directive 2011/84/EU). This concentration allows for faster results, but instead patients may suffer more frequently from dental sensitivity. The most commonly described side effect of all whitening procedures is the appearance of dentin hypersensitivity, hence the efforts to counteract or overcome this adverse effect.

The objective of the study is to clinically evaluate the difference in dental hypersensitivity produced by home dental whitening treatment using 16% carbamide peroxide in a tray for two hours daily applied daily or every other day for three weeks.

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Detailed Description

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Volunteers will be instructed to use the whitening gel once a day for 2 hours, completing a total of 3 weeks of whitening procedure. Depending on the randomization, the bleaching procedure will be performed every other day or daily. In the upper arch, the teeth to be whitened will be from 15 to 25. The evaluations of efficacy, dental sensitivity and satisfaction will be carried out in the upper and lower arch. The color will be recorded before, weekly for 1 month, 6 months and 12 months after finishing the treatment. Shade assessment using the subjective method will be recorded with the Vita Classical color scale (Vita Zahnfabrik, Bad Säckingen, Germany), it will also be determined with the Vita 3D-MASTER scale (Vita Zahnfabrik, Bad Säckingen, Germany). For objective evaluation, the Vita Easyshade spectrophotometer (Vita Zahnfabrik, Bad Säckingen, Germany) will be used, according to the CIEL\*a\*b\* system.

Conditions

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Dental Hypersensitivity Teeth Whitening

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Each volunteer will be given 3 syringes of 16% carbamide peroxide bleaching gel to use on the splint. Volunteers will be instructed to use the whitening gel once a day for 2 hours, completing a total of 3 weeks of whitening procedure. Depending on the randomization, the whitening procedure will be performed on alternate days or daily. In the upper arch, the teeth to be whitened will be from 15 to 25 and in the lower one from 35 to 45.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

The present study presents blinding of both the evaluator and the person who will carry out the statistical analysis, and therefore double-blind. The evaluators are considered blind in this study because they do not know the randomization of the patients, being a blind study. The operator and patients know the groups in which they are assigned, due to the delivery and placement of the splints.

A block randomization of the treatment applied to the patients will be carried out, to ensure that the sample size is similar in both groups. The operator will open an envelope for the group's allocation. The assignment of the groups will be carried out using opaque, sealed and sequentially numbered envelopes. The operator will open the envelope when the splints are delivered, and will give the pertinent explanations to the patient. Data will be collected from each patient that may influence treatment results such as age, sex, initial color, systemic pathologies and pharmacological treatments.

Study Groups

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Daily whitening

Volunteers should whiten daily with a whitening tray from 15 to 25 and 35 to 45 for 2 hours. This procedure will last 3 weeks.

Group Type ACTIVE_COMPARATOR

Daily whitening

Intervention Type OTHER

Daily application of a 16% carbamide peroxide bleaching gel in volunteers without sensitivity.

Alternate whitening

Volunteers will bleach for 3 weeks with 16% carbamide peroxide, alternating one rest day for each placement day. They will wear a whitening tray from 15 to 25 and from 35 to 45 for 2 hours.

Group Type EXPERIMENTAL

Alternate whitening

Intervention Type OTHER

Volunteers will apply the whitening gel at 16% carbamide peroxide, alternating a rest day with an application day. Patients should not be sensitive before starting the study.

Interventions

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Daily whitening

Daily application of a 16% carbamide peroxide bleaching gel in volunteers without sensitivity.

Intervention Type OTHER

Alternate whitening

Volunteers will apply the whitening gel at 16% carbamide peroxide, alternating a rest day with an application day. Patients should not be sensitive before starting the study.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients older than 18 years.
* Patients with vital teeth without restorations, single crowns, implants and/or bridges at the level of the anterior teeth.
* Absence of cavities in the teeth to be whitened.
* Patients with satisfactory oral hygiene and periodontally healthy, who are not undergoing periodontal maintenance and who do not use chlorhexidine mouthwashes. Patients with recessions without presenting sensitivity will be included.
* Absence of sensitivity, measured with the application of air with the dental team's syringe.
* Patients whose canines have at least an A2-A3 shade (VITA Classic® Guide).

Exclusion Criteria

* Patients who have previously undergone whitening (less than 5 years).
* Patients undergoing orthodontic treatment.
* Patients with white spots or alterations in the development of enamel or with stains.
* Patients with a history of trauma to anterior teeth.
* Patients who require internal whitening.
* Smokers.
* Pregnant or lactating.
* Patients with allergies to any whitening component.
* Patients presenting alterations of the oral mucosa (desquamative gingivitis, oral lichen planus, leukoplakia, etc.).
* Patients with medical conditions considered by the researchers that may compromise the study or the individual safety of the patient.
* Patients with poor oral hygiene.
* Patients with previous hypersensitivity.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes