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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03044171

Enrollment

Registered

2017-02-06

Start date

2016-08-01

Completion date

2017-02-23

Last updated

2017-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dentin Sensitivity

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 .

Interventions

DEVICELow Level Laser Therapy

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.

DRUG1.1% Sodium Fluoride

Fluoride therapy: 1.1% sodium fluoride 5000 ppm was applied for 5 minutes on the vestibular surface of all pre-bleached dental elements.

DRUGIn-office dental bleaching

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.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 25 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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).
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).

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026