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Completed

NCT Number: NCT03044171

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

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

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Key information

Conditions

Dentin Sensitivity Stomatognathic Diseases Tooth Diseases

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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 .

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Low Level Laser Therapy

Device

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.

Other names: LLLT

1.1% Sodium Fluoride

Drug

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

Other names: Fluoride therapy

In-office dental bleaching

Drug

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.

Other names: 35% hydrogen peroxide

Primary outcomes

  1. Stimulated pain intensity measure (P5)

    Time frame: 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 outcomes

  1. Non-stimulated pain intensity measure, (P28)

    Time frame: 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).

  2. Recurrence of stimulated pain

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Universidade Federal do Para

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 6, 2017
Registry last updated
Mar 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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