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

NCT06035588 | Completed DMC

• 1 other identifier: URJC University
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Hypersensitivity; Teeth Whitening

Keywords

bleaching; hipersensitivity; whitening; at-home; carbamide

Outcome Measures

Primary Outcomes (1)

• 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.

  3 weeks

Secondary Outcomes (1)

• Whitening Efficacy CIEL*a*b*

  1 month

Other Outcomes (2)

• Gingival irritation VAS (0-10)

  3 weeks

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

  1 month

Study Arms (2)

Daily whitening

ACTIVE COMPARATOR

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

Alternate whitening

EXPERIMENTAL

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

Interventions

Daily whitening OTHER

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

Daily whitening

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.

Alternate whitening

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Rey Juan Carlos: lead

Study Sites (1)

Isabel Giraldez de Luis

Alcorcón, Madrid, 28922, Spain

Location

Related Publications (3)

• 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.

  PMID: 20884923 BACKGROUND

• 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.

  PMID: 31335161 BACKGROUND

• 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.

  PMID: 29949477 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Department for Conservative Dentistry at Rey Juan Carlos University

Model Details: 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.

Study Record Dates

• First Submitted: September 6, 2023
• First Posted: September 13, 2023
• Study Start: January 6, 2024
• Primary Completion: February 27, 2025
• Study Completion: September 1, 2025
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)