Evaluation of the Effect of Fluoride and Laser Application on the Prevention of Sensitivity in Bleached Teeth

Study Overview
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Brief Summary
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To investigate the effects of desensitizing agents on the dental bleaching process, testing the hypothesis that they may prevent dental sensitivity.

Detailed Description
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The objective of this double blind, randomized and controlled clinical study, was to evaluate the efficacy of 1.1% sodium fluoride associated with LLLT (Low Level Laser Therapy) on teeth that were exposed to 35% hydrogen peroxide during 4 weeks of bleaching treatment. Methods: 25 volunteers were evaluated through the split-mouth model, where the hemiarcates were ranzomized and later allocated in one of the experimental groups: G-FLUOR+LASER - constitutes the group treated with LLLT + 1.1% sodium fluoride; and G-FLUOR - constitutes the group treated with placebo + 1.1% sodium fluoride .

Official Title
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Effect of Sodium Fluoride at 1.1%, Associated or Not With the Low-level Light Therapy in the Prevention of Post-bleaching Sensitivity: a Randomized, Double-blind, Controlled Trial

Conditions
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Dentin Sensitivity

Intervention / Treatment
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* Device: Low Level Laser Therapy
* Drug: 1.1% Sodium Fluoride
* Drug: In-office dental bleaching


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Absence of active carious lesions; Good oral hygiene; Do not present hypersensitivity; Do not smoke; Not being pregnant. Exclusion Criteria: Presence of periodontal disease; Presence of cracks or fractures; Presence of restorations and prostheses; Presence of gastroesophageal dysfunction; Patients with severe internal dental dimming.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: G-FLUOR+LASER<br>The corresponding hemiarcade received the application of Low Level Laser Therapy as a desensitizing treatment prior to in-office dental bleaching, followed by the application of 1.1% sodium fluoride after dental bleaching. | Device: Low Level Laser Therapy<br>* Laser therapy: it was used the infrared spectrum with wavelength of 808 nm in its active environment AsGaAl, in two points: cervical and central-medial region of the incisors, canines and premolars.<br>* Other names: LLLT;Drug: 1.1% Sodium Fluoride<br>* Fluoride therapy: 1.1% sodium fluoride 5000 ppm was applied for 5 minutes on the vestibular surface of all pre-bleached dental elements.<br>* Other names: Fluoride therapy;Drug: In-office dental bleaching<br>* Both groups received the in-office bleaching treatment. Three 15-minute applications of the 35% hydrogen peroxide gel were performed, totaling 45 minutes in each of the 4 sessions, with a 7-day interval.<br>* Other names: 35% hydrogen peroxide;|
| Experimental: G-FLUOR<br>The correspondent hemiarcade received only the positioning of the inactive laser tip (placebo), prior to in-office dental bleaching, followed by the application of 1.1% sodium fluoride as a desensitizing treatment after dental bleaching | Drug: 1.1% Sodium Fluoride<br>* Fluoride therapy: 1.1% sodium fluoride 5000 ppm was applied for 5 minutes on the vestibular surface of all pre-bleached dental elements.<br>* Other names: Fluoride therapy;Drug: In-office dental bleaching<br>* Both groups received the in-office bleaching treatment. Three 15-minute applications of the 35% hydrogen peroxide gel were performed, totaling 45 minutes in each of the 4 sessions, with a 7-day interval.<br>* Other names: 35% hydrogen peroxide;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stimulated pain intensity measure (P5) | Self reported stimulated pain intensity assessed weekly, by modified visual scale, at baseline, after first, second, third and fourth in-office bleaching application. Each item is scored 0-3 (0 = no pain; 3 = pain as bad as can be). | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-stimulated pain intensity measure, (P28) | Self reported non-stimulated pain intensity, assessed daily, by modified visual scale. Each item is scored 0-3 (0 = no pain; 3 = pain as bad as can be). | 28 days | 
| Recurrence of stimulated pain | Return of stimulated pain after one month of the last intervention. Item is scored 0-3 (0 = no pain; 3 = pain as bad as can be). | 2 months |