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

Phase 1

Completed

• Conditions: Dentin Sensitivity
• Interventions: Device: Low Level Laser Therapy; Drug: 1.1% Sodium Fluoride; Drug: In-office dental bleaching

• Registration Number: NCT03044171
• Lead Sponsor: Universidade Federal do Para

Brief Summary

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

Detailed Description

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 .

Study Timeline

• Study Start: 2016-08-01
• Primary Completion: 2017-01-23
• Study First Submitted: 2017-01-30
• Study First Submitted QC: 2017-02-02
• Study First Posted: 2017-02-06
• Study Completion: 2017-02-23
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-16
• Last Update Posted: 2017-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
G-FLUOR+LASER	Low Level Laser Therapy	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.
G-FLUOR+LASER	1.1% Sodium Fluoride	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.
G-FLUOR+LASER	In-office dental bleaching	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.
G-FLUOR	1.1% Sodium Fluoride	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
G-FLUOR	In-office dental bleaching	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

Primary Outcome Measures

Name	Time	Method
Stimulated pain intensity measure (P5)	4 weeks	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).

Secondary Outcome Measures

Name	Time	Method
Recurrence of stimulated pain	2 months	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).
Non-stimulated pain intensity measure, (P28)	28 days	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).