Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06538129
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-31
Brief Title:
Assessment of ErYAG Laser for the Control of Hypersensitivity During Tooth Whitening With Hydrogen Peroxide
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Assessment of ErYAG Laser for the Control of Hypersensitivity During Tooth Whitening With Hydrogen Peroxide Protocol for a Split-Mouth Controlled Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ErYAG 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 ErYAG 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 ErYAG laser 2940 nm will be used with the following parameters 015 W 10 mJ 15 Hz and SP mode pulse duration 300 µs TIP Cylindrical Quartz 10004 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 005
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 ErYAG 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 ErYAG laser 2940 nm will be used with the following parameters 015 W 10 mJ 15 Hz and SP mode pulse duration 300 µs TIP Cylindrical Quartz 10004 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 005
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None