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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE March 15, 2018
First Posted Date  ICMJE May 2, 2018
Last Update Posted Date May 2, 2018
Actual Study Start Date  ICMJE July 11, 2016
Actual Primary Completion Date August 8, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 30, 2018)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 30, 2018)
Color change promoted by tooth bleaching [ Time Frame: change in baseline color at the 3rd bleaching session ]
Spectrophotometer was used to measure the color
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Low-level Laser Therapy on Post-bleaching Sensitivity and Color Change
Official Title  ICMJE Effect of Low-level Laser Therapy on Post-bleaching Sensitivity and Color Change: a Clinical, Randomized and Double-blind Study
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Tooth Bleaching
  • Low-level Laser Therapy
  • Dentin Sensitivity
  • Clinical Trial
Intervention  ICMJE
  • 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.
  • Other: Placebo
    The laser tip was positioned similarly to experimental group but without light irradiation
Study Arms  ICMJE
  • Placebo Comparator: GPLACEBO
    the laser tip was positioned without the emission of light (placebo effect) + tooth bleaching with 35% hydrogen peroxide (HP).
    Interventions:
    • Other: Tooth bleaching
    • Other: Placebo
  • Experimental: GLASER
    treated with Low-lever laser + tooth bleaching with 35% hydrogen peroxide (HP).
    Interventions:
    • Radiation: Low-lever laser
    • Other: Tooth bleaching
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 30, 2018)
21
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 30, 2016
Actual Primary Completion Date August 8, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 30 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03514290
Other Study ID Numbers  ICMJE UFPara-003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Cecy Martins Silva, Universidade Federal do Para
Study Sponsor  ICMJE Universidade Federal do Para
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Cecy M Silva Federal University of Para
PRS Account Universidade Federal do Para
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP