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NCT Number: NCT06538129

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

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).

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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

  1. Color assessment (instrumental method)

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

    A contact intraoral spectrophotometer (Vita Easyshade, Vita-Zanhnfabrik, Bad Säckingen, Germany) will be used following the manufacturer's instructions and the method described by Kim-Pusateri et al. (2009). Readings will be made in the central portion of each tooth (central incisors, lateral incisors and canines of the maxillary arch) on twice consecutively. If identical, the values will be recorded. Otherwise, new readings will be made until identical values are achieved. Only one result will be recorded for each tooth.

Sponsors and collaborators

Lead sponsor

University of Nove de Julho

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Aug 5, 2024
Registry last updated
Aug 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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