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

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

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

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.




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



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03514290


Locations
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Brazil
Federal University of Pará
Belém, PA, Brazil, 66075-110
Sponsors and Collaborators
Universidade Federal do Para
Investigators
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Principal Investigator: Cecy M Silva Federal University of Para

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Responsible Party: Cecy Martins Silva, Full professor, Universidade Federal do Para
ClinicalTrials.gov Identifier: NCT03514290     History of Changes
Other Study ID Numbers: UFPara-003
First Posted: May 2, 2018    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Hypersensitivity
Dentin Sensitivity
Immune System Diseases
Tooth Diseases
Stomatognathic Diseases
Hydrogen Peroxide
Anti-Infective Agents, Local
Anti-Infective Agents