Assessment of Er:YAG Laser for the Control of Hypersensitivity During Tooth Whitening With Hydrogen Peroxide: Protocol for a Split-Mouth Controlled Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- University of Nove de Julho
- Enrollment
- 28
- Primary Endpoint
- Assessment of Dental Hypersensitivity
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •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.
Arms & Interventions
Experimental Group
The participants will receive the hypersensitivity prevention protocol with Er:YAG laser in cervical region (central incisor, lateral incisor and canine).
Intervention: Hypersensitivity prevention protocol with Er:YAG laser (Procedure)
Control Group
The participants will receive the hypersensitivity prevention protocol with neutral sodium fluoride gel for 4 minutes (central incisor, lateral incisor and canine).
Intervention: Hypersensitivity prevention protocol with neutral sodium fluoride gel (Procedure)
Outcomes
Primary Outcomes
Assessment of Dental Hypersensitivity
Time Frame: At baseline as well as after the hypersensitivity prevention protocol, immediately after bleaching, 48 hours after bleaching and one week after bleaching.
The patients will be given a questionnaire with the VAS for the measurement of dental hypersensitivity. The patient will indicate the severity of tooth sensitivity by marking a vertical line along a 10-cm horizontal line with 0 (no sensitivity) printed at one end and 10 (severe sensitivity) at the other end for all teeth that receive treatment.
Secondary Outcomes
- Color assessment (instrumental method)(Before and immediately after bleaching as well as 48 horas and one week after bleaching.)
Investigators
Sandra Kalil Bussadori
Principal Investigator
University of Nove de Julho