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Trial record 11 of 32 for:    FLUORIDE ION AND NITRATE ION

Effect of Laser and Potassium Nitrate Application on the Sensitivity Control in Bleached Teeth

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ClinicalTrials.gov Identifier: NCT03434782
Recruitment Status : Completed
First Posted : February 15, 2018
Last Update Posted : February 15, 2018
Sponsor:
Collaborator:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
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 control dental sensitivity.

Condition or disease Intervention/treatment Phase
Dentin Sensitivity Drug: In-office dental bleaching Drug: Low Level Laser Therapy Drug: 5% potassium nitrate / 2% sodium fluoride gel Phase 1

Detailed Description:
The objective of this double blind, randomized and controlled clinical study, was to evaluate the efficacy of potassium nitrate / sodium fluoride (KNO3 / KF) gel associated with LLLT (Low Level Light Therapy) on teeth that were exposed to 35% hydrogen peroxide during 3 weeks of bleaching treatment. Methods: 50 volunteers were evaluated through the split-mouth model, where the hemiarcates were randomized and later allocated in one of the experimental groups: G1 (negative control)- group with no desensitizing treatment, only bleached; G2 (positive control)- group treated with LLLT + placebo gel; G3- group treated with placebo laser application + 5% KNO3 / 2% KF gel; and G4- group treated with LLLT + 5% KNO3 / 2% KF gel.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Low-level Light Therapy Associated With Potassium Nitrate in the Control of Post-bleaching Dental Sensitivity: a Randomized, Double-blind, Split-mouth, Controlled Trial
Actual Study Start Date : April 24, 2017
Actual Primary Completion Date : November 24, 2017
Actual Study Completion Date : January 15, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy Potassium

Arm Intervention/treatment
Experimental: G1- Negative Control
Group with no desensitizing treatment. Prior to bleaching therapy, a water-soluble placebo gel, with non-active agent will be applied to dental vestibular surfaces. After bleaching therapy, the LASER tip will be positioned in two points (apical and cervical), without light emission (placebo).
Drug: In-office dental bleaching
The group will receive in-office bleaching treatment. Three 15-minute applications of the 35% hydrogen peroxide gel were performed, totaling 45 minutes in each of the 3 sessions, with a 7-day interval.
Other Name: 35% hydrogen peroxide

Experimental: G2- LASER (Positive Control)
Group treated with placebo gel before bleaching and with LLLT after in-office bleaching.
Drug: In-office dental bleaching
The group will receive in-office bleaching treatment. Three 15-minute applications of the 35% hydrogen peroxide gel were performed, totaling 45 minutes in each of the 3 sessions, with a 7-day interval.
Other Name: 35% hydrogen peroxide

Drug: Low Level Laser Therapy
It will be used the infrared spectrum with wavelength of 808 nm in its active environment AsGaAl, in two points: cervical and apical region of the incisors, canines and premolars.
Other Name: LLLT

Experimental: G3- KNO3 (Positive Control)
Group treated with desensitizing gel before bleaching and after in-office bleaching, the LASER tip will be positioned in two points (apical and cervical), without light emission (placebo).
Drug: In-office dental bleaching
The group will receive in-office bleaching treatment. Three 15-minute applications of the 35% hydrogen peroxide gel were performed, totaling 45 minutes in each of the 3 sessions, with a 7-day interval.
Other Name: 35% hydrogen peroxide

Drug: 5% potassium nitrate / 2% sodium fluoride gel
5% potassium nitrate / 2% sodium fluoride gel will be applied for 10 minutes on the vestibular surface of all pre-bleached dental elements, following the manufacturer`s protocol.
Other Name: desensitizing therapy

Experimental: G4- KNO3 + LASER
Group treated with desensitizing gel before bleaching and with LLLT after in-office bleaching.
Drug: In-office dental bleaching
The group will receive in-office bleaching treatment. Three 15-minute applications of the 35% hydrogen peroxide gel were performed, totaling 45 minutes in each of the 3 sessions, with a 7-day interval.
Other Name: 35% hydrogen peroxide

Drug: Low Level Laser Therapy
It will be used the infrared spectrum with wavelength of 808 nm in its active environment AsGaAl, in two points: cervical and apical region of the incisors, canines and premolars.
Other Name: LLLT

Drug: 5% potassium nitrate / 2% sodium fluoride gel
5% potassium nitrate / 2% sodium fluoride gel will be applied for 10 minutes on the vestibular surface of all pre-bleached dental elements, following the manufacturer`s protocol.
Other Name: desensitizing therapy




Primary Outcome Measures :
  1. Change in Stimulated pain intensity in different assessment times (P15) [ Time Frame: 15 days, with assessments in the 1st, 8th and 15th day of the treatment ]
    The stimulated pain intensity was self reported by the patients with a modified visual analog scale, from 0 to 3, where 0 means "no pain", 1 is "mild pain", 2 is "moderate pain" and 3 is "severe pain". For all groups, the patients evaluated the stimulated pain intensity two times per session: before and after the treatment in the same day. Thus, in total each patient reported the pain intensity 6 times, two times in the first day (1st session), two times in the eighth day (2nd session) and two times in the fifteenth day (3rd session).


Secondary Outcome Measures :
  1. Non-stimulated pain intensity measure, (P21) [ Time Frame: 21 days ]
    Self reported non-stimulated pain intensity was assessed daily, during 21 days, through self-perception questionnaire, answered by the patients from the first tooth bleaching session until one week after the last session. The evaluation was performed by each patient, according to a modified visual analog scale, as follows: 0- no pain, 1 mild pain, 2 - moderate pain and 3 -severe pain



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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Absence of active carious lesions;
  • Never undergone bleaching therapy;
  • Good oral hygiene;
  • Do not present hypersensitivity;
  • Do not smoke;
  • Not being pregnant;
  • Presence of at least 28 teeth in oral cavity.

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;
  • Presence of periodontal disease;
  • Presence of dentin exposure in anterior and/or posterior teeth.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03434782


Locations
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Brazil
Brennda Lucy Freitas de Paula
Belem, Para, Brazil, 66055-280
Sponsors and Collaborators
Universidade Federal do Para
Conselho Nacional de Desenvolvimento Científico e Tecnológico

Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 60622416.1.0000.0018

Publications of Results:
Other Publications:
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Responsible Party: Cecy Martins Silva, Associate Professor, Universidade Federal do Para
ClinicalTrials.gov Identifier: NCT03434782     History of Changes
Other Study ID Numbers: UFPara-002
First Posted: February 15, 2018    Key Record Dates
Last Update Posted: February 15, 2018
Last Verified: February 2018
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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Fluorides
Sodium Fluoride
Dentin Sensitivity
Hypersensitivity
Immune System Diseases
Tooth Diseases
Stomatognathic Diseases
Listerine
Hydrogen Peroxide
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents