Effect of Low-level Laser Therapy on Post-bleaching Sensitivity and Color Change
Primary Purpose
Tooth Bleaching, Low-level Laser Therapy, Dentin Sensitivity
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Low-lever laser
Tooth bleaching
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Tooth Bleaching focused on measuring Laser, Color
Eligibility 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
Sites / Locations
- Federal University of Pará
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
GPLACEBO
GLASER
Arm Description
the laser tip was positioned without the emission of light (placebo effect) + tooth bleaching with 35% hydrogen peroxide (HP).
treated with Low-lever laser + tooth bleaching with 35% hydrogen peroxide (HP).
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Color change promoted by tooth bleaching
Spectrophotometer was used to measure the color
Full Information
NCT ID
NCT03514290
First Posted
March 15, 2018
Last Updated
April 30, 2018
Sponsor
Universidade Federal do Para
1. Study Identification
Unique Protocol Identification Number
NCT03514290
Brief Title
Effect of Low-level Laser Therapy on Post-bleaching Sensitivity and Color Change
Official Title
Effect of Low-level Laser Therapy on Post-bleaching Sensitivity and Color Change: a Clinical, Randomized and Double-blind Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
July 11, 2016 (Actual)
Primary Completion Date
August 8, 2016 (Actual)
Study Completion Date
September 30, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Para
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Bleaching, Low-level Laser Therapy, Dentin Sensitivity, Clinical Trial
Keywords
Laser, Color
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
ParticipantInvestigator
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.
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GPLACEBO
Arm Type
Placebo Comparator
Arm Description
the laser tip was positioned without the emission of light (placebo effect) + tooth bleaching with 35% hydrogen peroxide (HP).
Arm Title
GLASER
Arm Type
Experimental
Arm Description
treated with Low-lever laser + tooth bleaching with 35% hydrogen peroxide (HP).
Intervention Type
Radiation
Intervention Name(s)
Low-lever laser
Other Intervention Name(s)
Laserterapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Tooth bleaching
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
The laser tip was positioned similarly to experimental group but without light irradiation
Primary Outcome Measure Information:
Title
Dental sensitivity induced by office bleaching
Description
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 Outcome Measure Information:
Title
Color change promoted by tooth bleaching
Description
Spectrophotometer was used to measure the color
Time Frame
change in baseline color at the 3rd bleaching session
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cecy M Silva
Organizational Affiliation
Federal University of Para
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal University of Pará
City
Belém
State/Province
PA
ZIP/Postal Code
66075-110
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Low-level Laser Therapy on Post-bleaching Sensitivity and Color Change
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