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Completed

NCT Number: NCT06035588

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

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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Key information

Conditions

Dental Hypersensitivity Teeth Whitening

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Isabel Giraldez de Luis

Alcorcón, Madrid, 28922, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Daily whitening

Other

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

Alternate whitening

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.

Primary outcomes

  1. Dental Sensitivity Visual Analog Scale (VAS) 0-10

    Time frame: 3 weeks

    The aim of this study is to clinically evaluate the incidence of tooth sensitivity induced by home whitening with 16% carbamide peroxide applied in a tray for two hours daily or every other day for three weeks. For the assessment, the operators will apply air to the cervical area of the upper and lower canines and ask the patient if he/she experienced sensitivity at any time during the treatment.

Secondary outcomes

  1. Whitening Efficacy CIEL*a*b*

    Time frame: 1 month

    To assess whether the efficacy of the 16% carbamide peroxide bleaching treatment described above when used every other day is the same as when used every day, or whether there is a difference in bleaching efficacy. This will be determined at check-ups by measuring the upper and lower canines with the Vita EasyShade V® spectrophotometer, based on the CIEL*a*b* system, according to the CIELAB system, CIEDE2000 and the whiteness index. Where L* represents the value from 0 (black) to 100 (white) and a* and b* represent the colour, where a* is the measurement along the red-green axis and b* is the measurement along the yellow-blue axis. In addition, the operators will take shade readings on all 4 canines using the VITA Classical and 3D-MASTER guides.

Other outcomes

  1. Gingival irritation VAS (0-10)

    Time frame: 3 weeks

    Using the Visual Analogue Scale, compare the presence of gingival irritation after every other day bleaching with 16% carbamide peroxide compared to daily application. The patient should rate the gingival irritation experienced on a scale of 0 to 10, with 10 being very irritating and 0 being not irritating at all.

  2. Patient's oral quality of life (OHIP-14)

    Time frame: 1 month

    The impact of treatment outcome on the patient's oral quality of life (OHIP-14) will be assessed using a questionnaire after 16% carbamide peroxide home bleaching. The patient will complete a 14-question questionnaire on a daily basis, regardless of which group he/she belongs to, daily or alternate application.

Sponsors and collaborators

Lead sponsor

Universidad Rey Juan Carlos

Other

Registry information

Official study title

Efficacy in the Reduction of Hypersensitivity During Home Whitening With 16% Carbamide Peroxide Applied on Alternate Days: a Randomized Clinical Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 13, 2023
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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