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

NCT03514290 | Completed DMC

• 1 other identifier: UFPara-003
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Laser; Color

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Color change promoted by tooth bleaching

  change in baseline color at the 3rd bleaching session

Study Arms (2)

GPLACEBO

PLACEBO COMPARATOR

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

Other: Tooth bleaching; Other: Placebo

GLASER

EXPERIMENTAL

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

Radiation: Low-lever laser; Other: Tooth bleaching

Interventions

Low-lever laser 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.

Also known as: Laserterapy

GLASER

Tooth bleaching 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.

GLASER; GPLACEBO

Placebo OTHER

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

GPLACEBO

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Do not have previous dental sensitivity
• The canine had to be shade A2 or darker.

You may not qualify if:

• Enamel hypoplasia
• Gingival recession
• Dentin exposure
• Visible cracks on buccal enamel
• Pulpitis

Sponsors & Collaborators

• Universidade Federal do Para: lead

Study Sites (1)

Federal University of Pará

Belém, Pará, 66075-110, Brazil

Location

MeSH Terms

Conditions

Dentin Sensitivity

Interventions

Tooth Bleaching

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Esthetics, Dental; Dentistry

Study Officials

• Cecy M Silva

  Federal University of Para

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full professor

Model Details: 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.

Study Record Dates

• First Submitted: March 15, 2018
• First Posted: May 2, 2018
• Study Start: July 11, 2016
• Primary Completion: August 8, 2016
• Study Completion: September 30, 2016
• Last Updated: May 2, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)