Effect of Low-level Laser Therapy on Post-bleaching Sensitivity and Color Change

Dentin Sensitivity Clinical Trial

Official title:

Effect of Low-level Laser Therapy on Post-bleaching Sensitivity and Color Change: a Clinical, Randomized and Double-blind Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03514290
• Other study ID #: UFPara-003
• Status: Completed
• Phase: N/A
• Start date: July 11, 2016
• Est. completion date: September 30, 2016

Study information

• Verified date: April 2018
• Source: Universidade Federal do Para
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Objective: The objective of this clinical study was to evaluate low-level laser (LLL) therapy in tooth sensitivity and in effecting color change after in-officer bleaching treatment across three weeks of treatment.

Methods: Twenty-one volunteers were evaluated through the split-mouth model, so that the right and left maxillary/mandibular quadrants were randomized and allocated to one of two groups: GPLACEBO - the laser tip was positioned without the emission of light (placebo effect) + tooth bleaching with 35% hydrogen peroxide (HP); GLASER - treated with LLL + tooth bleaching with 35% HP. To assess tooth sensitivity, a modified visual analogue scale (VAS) was used after an evaporative stimulus (stimulated pain) and a daily pain questionnaire (unstimulated pain) was also applied. A spectrophotometer was used to measure the color. Three bleaching sessions were performed, with intervals of 7 days. Sensitivity results were tested using Friedman test for intra-group evaluation and Wilcoxon test for inter-group evaluation and ANOVA for color change.

Description:

Twenty-one volunteers were evaluated through the split-mouth model, so that the right and left maxillary/mandibular quadrants were randomized and allocated to one of two groups: GPLACEBO - the laser tip was positioned without the emission of light (placebo effect) + tooth bleaching with 35% hydrogen peroxide (HP); GLASER - treated with LLL + tooth bleaching with 35% HP. To assess tooth sensitivity, a modified visual analogue scale (VAS) was used after an evaporative stimulus (stimulated pain) and a daily pain questionnaire (unstimulated pain) was also applied. A spectrophotometer was used to measure the color. Three bleaching sessions were performed, with intervals of 7 days.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: September 30, 2016
• Est. primary completion date: August 8, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

• Do not have previous dental sensitivity

• The canine had to be shade A2 or darker.

Exclusion Criteria:

• Enamel hypoplasia

• Gingival recession

• Dentin exposure

• Visible cracks on buccal enamel

• Pulpitis

Related Conditions & MeSH terms

• Clinical Trial
• Dentin Sensitivity
• Hypersensitivity
• Low-level Laser Therapy
• Tooth Bleaching

Intervention

Radiation:
• Low-lever laser
Received Low-lever laser therapy using the infrared spectrum, with a wavelength of 808 nm in its active medium AsGaAl (arsenic-gallium-aluminum), at two points: on the central of cervical and medial regions of incisors, canines and premolars in the corresponding hemi-arch. At each point, 60 J/cm2 was applied during 16 seconds with an irradiance of 3.75 W/cm² using the therapeutic visible infrared device.

Other:
• Tooth bleaching
Three 15-minute applications of 35% hydrogen peroxide gel (Whiteness HP, FGM®, Joinville, SC, Brazil) were carried out, totaling 45 minutes in each of the four bleaching sessions, with an one-week interval between applications.
• Placebo
The laser tip was positioned similarly to experimental group but without light irradiation

Locations

Country	Name	City	State
Brazil	Federal University of Pará	Belém	PA

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal do Para

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dental sensitivity induced by office bleaching	Evaporative stimulus (stimulated pain) using air jet from a triple syringe and a daily pain questionnaire (unstimulated pain). Both methods were associated with a modified visual analogue scale was used: 0 (pain absent); 1 (mild pain); 2 (moderate pain) and 3 (severe pain).	change in baseline sensitivity at the 3rd bleaching session
Secondary	Color change promoted by tooth bleaching	Spectrophotometer was used to measure the color	change in baseline color at the 3rd bleaching session