An interventional study of Daily whitening and Alternate whitening in Dental Hypersensitivity and Teeth Whitening, sponsored by Universidad Rey Juan Carlos. Completed at 1 site in Spain. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-10-02.
Sponsored by Universidad Rey Juan Carlos · Not applicable, Interventional, and Treatment
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.
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.
Universidad Rey Juan Carlos is the lead sponsor of 111 studies on the registry; 22 are open to participants now.
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Exclusion Criteria:
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.
Other: Daily 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.
Other: Alternate whitening
Daily application of a 16% carbamide peroxide bleaching gel in volunteers without sensitivity.
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.
Dental Sensitivity Visual Analog Scale (VAS) 0-10
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.
Time frame: 3 weeks
Whitening Efficacy CIEL*a*b*
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.
Time frame: 1 month
Gingival irritation VAS (0-10)
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.
Time frame: 3 weeks
Patient's oral quality of life (OHIP-14)
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.
Time frame: 1 month
Plan to share: No — The results obtained will only be shared once they have been published in an impact journal.
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Universidad Rey Juan Carlos