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

NCT06035588 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2025-10-02

No results posted yet for this study

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

Interventions

OTHER

Daily whitening

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

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.

Sponsors & Collaborators

  • Universidad Rey Juan Carlos

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-06
Primary Completion
2025-02-27
Completion
2025-09-01

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06035588 on ClinicalTrials.gov