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

NCT ID: NCT03514290

Last Updated: 2018-05-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-11
• Study Completion Date: 2016-09-30

Brief 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.

Detailed 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.

Conditions

Tooth Bleaching; Low-level Laser Therapy; Dentin Sensitivity; Clinical Trial

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

GPLACEBO

the laser tip was positioned without the emission of light (placebo effect) + tooth bleaching with 35% hydrogen peroxide (HP).

Group Type: PLACEBO_COMPARATOR

Tooth bleaching

Intervention Type: OTHER

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

Intervention Type: OTHER

The laser tip was positioned similarly to experimental group but without light irradiation

GLASER

treated with Low-lever laser + tooth bleaching with 35% hydrogen peroxide (HP).

Group Type: EXPERIMENTAL

Low-lever laser

Intervention Type: RADIATION

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.

Tooth bleaching

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: RADIATION

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.

Intervention Type: OTHER

Placebo

The laser tip was positioned similarly to experimental group but without light irradiation

Intervention Type: OTHER

Other Intervention Names

Laserterapy

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidade Federal do Para

OTHER

Sponsor Role: lead

Responsible Party

Cecy Martins Silva

Full professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cecy M Silva

Role: PRINCIPAL_INVESTIGATOR

Federal University of Para

Locations

Federal University of Pará

Belém, Pará, Brazil

Countries

Brazil

Other Identifiers

UFPara-003

Identifier Type: -

Identifier Source: org_study_id