An interventional study of Hypersensitivity prevention protocol with Er:YAG laser and Hypersensitivity prevention protocol with neutral sodium fluoride gel in Hypersensitivity, Hypersensitivity, Immediate and Hypersensitivity Response, sponsored by University of Nove de Julho. Not yet recruiting. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-05.
Sponsored by University of Nove de Julho · Not applicable, Interventional, and Treatment
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).
82 studies on the registry are indexed under Hypersensitivity, Immediate; 7 are open to participants now.
This study's planned enrollment of 28 is below the median of 70 across 66 interventional studies indexed under Hypersensitivity, Immediate.
Browse Hypersensitivity, Immediate studies →University of Nove de Julho is the lead sponsor of 246 studies on the registry; 52 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 1 (13%) have results posted.
Compared within Hypersensitivity, Immediate, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Hypersensitivity. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
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.
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.
Time frame: At baseline as well as after the hypersensitivity prevention protocol, immediately after bleaching, 48 hours after bleaching and one week after bleaching.
Color assessment (instrumental method)
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.
Time frame: Before and immediately after bleaching as well as 48 horas and one week after bleaching.
No study locations are listed for this record.
Start is estimated for Nov 2024; primary completion for Dec 2025, 13 months later.
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This study is not yet recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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