Assessment of Er:YAG Laser for the Control of Hypersensitivity During Tooth Whitening With Hydrogen Peroxide

NCT06538129 | Not Yet Recruiting

• 1 other identifier: Er:YAG Laser
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity Response

Outcome Measures

Primary Outcomes (1)

• Assessment of Dental Hypersensitivity

  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.

  At baseline as well as after the hypersensitivity prevention protocol, immediately after bleaching, 48 hours after bleaching and one week after bleaching.

Secondary Outcomes (1)

• Color assessment (instrumental method)

  Before and immediately after bleaching as well as 48 horas and one week after bleaching.

Study Arms (2)

Experimental Group

EXPERIMENTAL

The participants will receive the hypersensitivity prevention protocol with Er:YAG laser in cervical region (central incisor, lateral incisor and canine).

Procedure: Hypersensitivity prevention protocol with Er:YAG laser

Control Group

EXPERIMENTAL

The participants will receive the hypersensitivity prevention protocol with neutral sodium fluoride gel for 4 minutes (central incisor, lateral incisor and canine).

Procedure: Hypersensitivity prevention protocol with neutral sodium fluoride gel

Interventions

Hypersensitivity prevention protocol with Er:YAG laser PROCEDURE

1.Prophylaxis using airflow system with erythritol, potency 5, water regulator 5; 2.Initial assessment of hypersensitivity using visual analogue scale (VAS); 3.Color assessment (canines, central incisors and lateral incisors) with digital spectrophotometer (Vita Easyshade,); 4.Placement of dental dam followed by photoactivation with Valo cordless curing light 5.Hypersensitivity prevention protocol with Er:YAG laser in cervical region (central incisor, lateral incisor and canine); 6.Application of whitening gel (1 mm in thickness) with 35% hydrogen peroxide on maxillary arch (Clareador Whiteness HP; FGM), left to react for 15 minutes; 7.Removal of whitening gel; 8.Repeat procedures (steps 7 and 8); 9.Assessment of hypersensitivity immediately after hypersensitivity prevention procedure, immediately after bleaching, 48 after bleaching and one week after bleaching; 10.Color assessment with digital immediately after bleaching, 48 after bleaching and one week after bleaching.

Experimental Group

Hypersensitivity prevention protocol with neutral sodium fluoride gel PROCEDURE

1.Prophylaxis using airflow system with erythritol, potency 5, water regulator 5; 2.Initial assessment of hypersensitivity using the VAS; 3.Color assessment (canines, central incisors and lateral incisors) with digital spectrophotometer (Vita Easyshade); 4.Placement of dental dam followed by photoactivation with Valo cordless; 5.Hypersensitivity prevention protocol with neutral sodium fluoride gel for 4 minutes (central incisor, lateral incisor and canine); 6.Application of whitening gel (1 mm in thickness) with 35% hydrogen peroxide on maxillary arch (Clareador Whiteness HP; FGM), left to react for 15 minutes; 7.Removal of whitening gel; 8.Repeat procedures (steps 7 and 8); 9.Assessment of hypersensitivity immediately after hypersensitivity prevention procedure, immediately after bleaching, 48 after bleaching and one week after bleaching; 10.Color assessment with digital spectrophotometer immediately after bleaching, 48 after bleaching and one week after bleaching.

Control Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nove de Julho: lead

MeSH Terms

Conditions

Hypersensitivity; Hypersensitivity, Immediate

Interventions

Lasers, Solid-State

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Split-mouth

Study Record Dates

• First Submitted: July 31, 2024
• First Posted: August 5, 2024
• Study Start: November 1, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: August 5, 2024

Record last verified: 2024-07