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Trial record 36 of 292 for:    Sodium Fluoride OR Duraphat

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

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ClinicalTrials.gov Identifier: NCT03044171
Recruitment Status : Completed
First Posted : February 6, 2017
Last Update Posted : March 17, 2017
Sponsor:
Information provided by (Responsible Party):
Cecy Martins Silva, 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.

Condition or disease Intervention/treatment Phase
Dentin Sensitivity Device: Low Level Laser Therapy Drug: 1.1% Sodium Fluoride Drug: In-office dental bleaching Phase 1

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 .

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official 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
Actual Study Start Date : August 1, 2016
Actual Primary Completion Date : January 23, 2017
Actual Study Completion Date : February 23, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Experimental: G-FLUOR+LASER
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
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 Name: LLLT

Drug: 1.1% 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.
Other Name: Fluoride therapy

Drug: In-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.
Other Name: 35% hydrogen peroxide

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

Drug: In-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.
Other Name: 35% hydrogen peroxide




Primary Outcome Measures :
  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 Outcome Measures :
  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).



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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 57655916.3.0000.0018

Publications of Results:
Other Publications:
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Responsible Party: Cecy Martins Silva, Associate Professor, Universidade Federal do Para
ClinicalTrials.gov Identifier: NCT03044171     History of Changes
Other Study ID Numbers: UFPara-001
First Posted: February 6, 2017    Key Record Dates
Last Update Posted: March 17, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Listerine
Fluorides
Sodium Fluoride
Dentin Sensitivity
Hypersensitivity
Immune System Diseases
Tooth Diseases
Stomatognathic Diseases
Hydrogen Peroxide
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents