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

• ClinicalTrials.gov Identifier: NCT03514290
• Recruitment Status: Completed
• First Posted: May 2, 2018
• Last Update Posted: May 2, 2018
• Sponsor: Universidade Federal do Para
• Information provided by (Responsible Party): Cecy Martins Silva, Universidade Federal do Para

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Tooth Bleaching; Low-level Laser Therapy; Dentin Sensitivity; Clinical Trial	Radiation: Low-lever laser; Other: Tooth bleaching; Other: Placebo	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 21 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model 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.
• Masking: Double (Participant, Investigator)
• Masking Description: Only principal investigator performed the clinical research steps. A single evaluator performed the assessment of the dental sensitivity without knowing which treatment was applied. The volunteers evaluated in this study also did not know which hemi-arch received the LLL.
• Primary Purpose: Treatment
• Official Title: Effect of Low-level Laser Therapy on Post-bleaching Sensitivity and Color Change: a Clinical, Randomized and Double-blind Study
• Actual Study Start Date: July 11, 2016
• Actual Primary Completion Date: August 8, 2016
• Actual Study Completion Date: September 30, 2016

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: GPLACEBO; the laser tip was positioned without the emission of light (placebo effect) + tooth bleaching with 35% hydrogen peroxide (HP).	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.; Other: Placebo; The laser tip was positioned similarly to experimental group but without light irradiation
Experimental: GLASER; treated with Low-lever laser + tooth bleaching with 35% hydrogen peroxide (HP).	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 Name: Laserterapy; 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.

Outcome Measures

Primary Outcome Measures :

1. Dental sensitivity induced by office bleaching [ Time Frame: change in baseline sensitivity at the 3rd bleaching session ]
   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).

Secondary Outcome Measures :

1. Color change promoted by tooth bleaching [ Time Frame: change in baseline color at the 3rd bleaching session ]
   Spectrophotometer was used to measure the color

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 30 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

Brazil

Federal University of Pará

Belém, PA, Brazil, 66075-110

Sponsors and Collaborators

Universidade Federal do Para

Investigators

• Principal Investigator: Cecy M Silva; Federal University of Para

More Information

• Responsible Party: Cecy Martins Silva, Full professor, Universidade Federal do Para
• ClinicalTrials.gov Identifier: NCT03514290
• Other Study ID Numbers: UFPara-003
• First Posted: May 2, 2018
• Last Update Posted: May 2, 2018
• Last Verified: April 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Cecy Martins Silva, Universidade Federal do Para:

Laser; Color

Additional relevant MeSH terms:

Dentin Sensitivity; Hypersensitivity; Immune System Diseases; Tooth Diseases; Stomatognathic Diseases