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

February 13, 2018 updated by: Cecy Martins Silva, Universidade Federal do Para

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Para
      • Belem, Para, Brazil, 66055-280
        • Brennda Lucy Freitas de Paula

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • desensitizing therapy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
15 days, with assessments in the 1st, 8th and 15th day of the treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidade Federal do Para

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Conselho Nacional de Desenvolvimento Científico e Tecnológico

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 24, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 24, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 15, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 16, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 15, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 15, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UFPara-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Study Data/Documents

  1. Study Protocol
    Information identifier: 60622416.1.0000.0018

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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