Clinical Comparison of LED- and Diode Laser-activated Bleaching

September 2, 2020 updated by: Aybuke Uslu, Hacettepe University

To clinically compare the effects of LED- or Diode laser-activated bleaching on colour change, tooth-sensitivity, gingival-irritation and temperature variation over 9-months.

Thirty-five patients with tooth colour A2 or higher will be included in the study. In a split-mouth design, using a 35% HP bleaching agent (Whiteness HP); one side of each mouth will be randomly activated by a diode laser (Epic X) and the other side by an LED (Radii Plus) light-source. During bleaching, the temperature variations will be recorded using a thermocouple from the buccal surface of canine teeth. Colour change (ΔSGU, ΔE) will be evaluated by subjective (Vita classic/bleached guide) and objective methods (spectrophotometry) before treatment and immediately, 48h, 1 week, 1, 6, 9 months after. Tooth-sensitivity and gingival- irritation will be assessed by visual analogue scale (VAS) and Gingival Index.

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

Objective: The aim of this split-mouth, randomized clinical study is to evaluate the effect of LED or Diode laser-activated bleaching applications on colour change, tooth sensitivity, gingival irritation and temperature variation with 35% hydrogen peroxide bleaching gel after 9 months. Material and Methods: Thirty-five patients with anterior teeth without caries and no restoration will be included in this study. In a split-mouth design, a bleaching agent containing 35% HP (Whiteness HP, FGM) will be used, one side of each jaw will be activated by a diode laser (Epic X, Biolase) and the other side will be activated by an LED (Radii Plus, SDI) light source. During the bleaching treatments, the temperature variations will be recorded using a thermocouple (DT-3891G K type Thermometer datalogger, CEM Instruments) from the buccal surface of canine teeth. Tooth sensitivity will be assessed by Visual Analogue Scale (VAS) before the treatment and during, immediately, 48 hours, 1 week, 1, 6 and 9 months after. Color change will be evaluated by subjective (Vita Classic and Vita 3D Master Bleachguide) and objective methods (Vita Easy Shade, spectrophotometer) before the treatment and immediately, 48 hours, 1 week, 1, 6 and 9 months after. Color change (ΔE and ΔSGU) will be performed by analysis of variance in repeated measurements. Multiple comparisons will be evaluated by Bonferroni test. Temperature variation will be evaluated by t-test in dependent groups. Tooth sensitivity will be analyzed using Friedman test. Wilcoxon test will be used to compare two light sources (Diode Laser/ LED) in each time period (p< 0.05).

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.
40

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.
  • Not Applicable

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

  • Turkey
      • Ankara, Turkey, 06230
        • Aybuke Uslu

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

19 years to 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy vital anterior teeth without restorations which have A2 or darker tooth shade on Vita Classical Scale (Vita Classical Scale, VITA Zahnfabrik, Bad Säckingen, Germany).

Exclusion Criteria:

  • Pregnant or lactating woman smokers Participants with periodontal diseases, tooth sensitivity internal tooth discoloration (tetracycline/ fluorosis stains), exposed engine, peroxides allergy malpositioned 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: SUPPORTIVE_CARE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

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: clinician
Comparison of LED and diode laser
Device: bleaching device
activated bleaching
Other Names:
  • whitness hp, FGM
  • Radii plus LED,SDI
  • Epic X, Biolase

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
Colour change
Time Frame: Baseline (before the treatment) and 48 hours, 1 week, 1, 6 and 9 months after.
Colour change will be evaluated by subjective (Vita Classic and Vita 3D Master Bleachguide) and objective methods (Vita Easy Shade, spectrophotometer).
Baseline (before the treatment) and 48 hours, 1 week, 1, 6 and 9 months after.
temperature
Time Frame: Procedure (During the bleaching treatments)
During the bleaching treatments, the temperature variations will be recorded using a thermocouple (DT-3891G K type Thermometer datalogger, CEM Instruments) from the buccal surface of canine teeth.
Procedure (During the bleaching treatments)
Tooth sensitivity
Time Frame: Baseline (before the treatment) and 48 hours, 1 week, 1, 6 and 9 months after.
Tooth sensitivity will be assessed by Visual Analogue Scale (VAS).
Baseline (before the treatment) and 48 hours, 1 week, 1, 6 and 9 months after.

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.
Hacettepe University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: A. Ruya Yazici, Prof., Hacettepe University

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.
June 19, 2018

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.
October 15, 2018

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.
May 5, 2019

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).
July 8, 2020

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.
September 2, 2020

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.
September 3, 2020

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.
September 4, 2020

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.
September 2, 2020

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.
September 1, 2020

More Information

Terms related to this study

Keywords

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.
  • AUslu

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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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