Clinical trial NCT06538129: Assessment of Er:YAG Laser for the Control of Hypersensitivity During Tooth Whitening With Hydrogen Peroxide
Official title: Assessment of Er:YAG Laser for the Control of Hypersensitivity During Tooth Whitening With Hydrogen Peroxide: Protocol for a Split-Mouth Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity Response
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2024-08-05
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Split-mouth
Primary purpose: TREATMENT

Brief summary: Introduction: Tooth whitening is an aesthetic procedure with rapid results that improves the self-esteem and self-image of patients. However, one of the side effects is dentinal hypersensitivity. The aim of the study is to assess the effectiveness of Er:YAG laser administered prior to bleaching with 35% hydrogen peroxide hypersensitivity.

Methods: The maxillary arch of participants 18 to 45 years of age will be treated using the split-mouth method. Grupo experimental: Hypersensitivity prevention protocol with Er:YAG laser followed by bleaching with 35% hydrogen peroxide; control group: hypersensitivity prevention protocol with neutral sodium fluoride for four minutes followed by bleaching with 35% hydrogen peroxide. Er:YAG laser (2940 nm) will be used with the following parameters: 0.15 W, 10 mJ, 15 Hz and SP mode (pulse duration: 300 µs), TIP: Cylindrical Quartz 1000/4, using the H14 handpiece (H14 for LightWalker AT; Fotona dd, Ljubljana, Slovenia). Each tooth (central incisor, lateral incisor and canine) will be irradiated twice for 10 s in an unfocused scanning motion in the cervical region at a working distance of 1 cm. The absolute risk and intensity of dentinal hypersensitivity during treatment will be assessed using the visual analogue scale. The change in color will be determined using an intraoral spectrophotometer in contact with the tooth. Assessments will be conducted before and after preventive treatment, immediately after treatment as well as 48 hours and one week after treatment. Different statistical tests will be used, with the significance level set at 5% (p ≤ 0.05).


Eligibility criteria: Inclusion Criteria:

* All anterior teeth present without caries or restorations;
* Absence of cervical lesions, dental pain and hypersensitivity prior to treatment;
* Not having previously undergone any tooth whitening procedure.

Exclusion Criteria:

* Smokers;
* Pregnant or nursing women;
* Individuals with gingivitis or periodontitis, those with enamel cracks detected by the transillumination test;
* Those with enamel defects or stains caused by tetracycline;
* Those with systemic diseases;
* Those taking nonsteroidal anti-inflammatory.

Primary outcomes:
measure: Assessment of Dental Hypersensitivity
timeFrame: At baseline as well as after the hypersensitivity prevention protocol, immediately after bleaching, 48 hours after bleaching and one week after bleaching.
Secondary outcomes:
measure: Color assessment (instrumental method)
timeFrame: Before and immediately after bleaching as well as 48 horas and one week after bleaching.
Other outcomes:
Locations:
Study officials:
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