Clinical trial NCT06035588: Efficacy in the Reduction of Hypersensitivity During Home Whitening With 16% Carbamide Peroxide Applied on Alternate Days
Official title: Efficacy in the Reduction of Hypersensitivity During Home Whitening With 16% Carbamide Peroxide Applied on Alternate Days: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dental Hypersensitivity
Teeth Whitening
Keywords: bleaching
hipersensitivity
whitening
at-home
carbamide
Lead sponsor: Universidad Rey Juan Carlos
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Dental Sensitivity
timeFrame: 3 weeks
Secondary outcomes:
measure: whitening efficacy
timeFrame: 1 month
Other outcomes:
measure: Gingival irritation
timeFrame: 3 weeks
measure: Patient's oral quality of life
timeFrame: 1 month
Locations:
city: Alcorcón
country: Spain
facility: Isabel Giraldez de Luis
state: Madrid
Study officials:
References:
citation: Cardoso PC, Reis A, Loguercio A, Vieira LC, Baratieri LN. Clinical effectiveness and tooth sensitivity associated with different bleaching times for a 10 percent carbamide peroxide gel. J Am Dent Assoc. 2010 Oct;141(10):1213-20. doi: 10.14219/jada.archive.2010.0048.
citation: Chagas AS, Freitas KMS, Cancado RH, Valarelli FP, Canuto LFG, Oliveira RCG, Oliveira RCG. Level of satisfaction in the use of the wraparound Hawley and thermoplastic maxillary retainers. Angle Orthod. 2020 Jan;90(1):63-68. doi: 10.2319/031319-197.1. Epub 2019 Jul 22.
citation: de Geus JL, Wambier LM, Boing TF, Loguercio AD, Reis A. At-home Bleaching With 10% vs More Concentrated Carbamide Peroxide Gels: A Systematic Review and Meta-analysis. Oper Dent. 2018 Jul/Aug;43(4):E210-E222. doi: 10.2341/17-222-L.