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CompletedNCT03514290Updated May 2, 2018

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

An interventional study of Low-lever laser and Tooth bleaching in Tooth Bleaching, Low-level Laser Therapy and Dentin Sensitivity, sponsored by Universidade Federal do Para. Completed at 1 site in Brazil. Open to participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-05-02.

Sponsored by Universidade Federal do Para · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 8 months after the study started (first participant enrolled Jul 2016, registered Mar 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
21
Allocation
Randomized
Ages
18 Years to 30 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

Keywords

  • Laser
  • Color
03

In context

Dentin Sensitivity

283 studies on the registry are indexed under Dentin Sensitivity; 45 are open to participants now.

This study's enrollment of 21 is below the median of 60 across 274 interventional studies indexed under Dentin Sensitivity.

Browse Dentin Sensitivity studies →

Lead sponsor

Universidade Federal do Para is the lead sponsor of 29 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Enamel hypoplasia
  • Gingival recession
  • Dentin exposure
  • Visible cracks on buccal enamel
  • Pulpitis
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
21 participants (actual)

Study arms

  • 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 · Other: Placebo

  • Experimental
    GLASER

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

    Radiation: Low-lever laser · Other: Tooth bleaching

Interventions

  • RadiationLow-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.

    Also known as: Laserterapy

  • OtherTooth 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.

  • OtherPlacebo

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

06

What researchers measure

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).

    Time frame: change in baseline sensitivity at the 3rd bleaching session

Secondary outcomes

  1. Color change promoted by tooth bleaching

    Spectrophotometer was used to measure the color

    Time frame: change in baseline color at the 3rd bleaching session

07

Study locations

1 site
  • Federal University of Pará
    Belém, PA 66075-110, Brazil
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 2, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03514290
Lead sponsor
Universidade Federal do Para
Responsible party
Cecy Martins Silva (Full professor, Universidade Federal do Para) — Principal investigator
First posted
May 2, 2018
Start date
Jul 11, 2016
Primary completion
Aug 8, 2016
Completion
Sep 30, 2016
Last update
May 2, 2018

Study contacts

Cecy M Silva
principal investigator · Federal University of Para

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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