Clinical trial NCT03514290: 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
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Bleaching
Low-level Laser Therapy
Dentin Sensitivity
Clinical Trial
Keywords: Laser
Color
Lead sponsor: Universidade Federal do Para
Sponsor class: OTHER
First posted: 2018-05-02
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Dental sensitivity induced by office bleaching
timeFrame: change in baseline sensitivity at the 3rd bleaching session
Secondary outcomes:
measure: Color change promoted by tooth bleaching
timeFrame: change in baseline color at the 3rd bleaching session
Other outcomes:
Locations:
city: Belém
country: Brazil
facility: Federal University of Pará
state: PA
Study officials:
affiliation: Federal University of Para
name: Cecy M Silva
role: PRINCIPAL_INVESTIGATOR
References: