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Clinical Comparison of LED- and Diode Laser-activated Bleaching

Primary Purpose

Color; Change Teeth, Posteruptive

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
bleaching device
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Color; Change Teeth, Posteruptive focused on measuring In-office tooth bleaching, Diode laser, LED, color change, tooth-sensitivity, temperature

Eligibility Criteria

19 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Aybuke Uslu

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

clinician

Arm Description

Comparison of LED and diode laser

Outcomes

Primary Outcome Measures

Colour change
Colour change will be evaluated by subjective (Vita Classic and Vita 3D Master Bleachguide) and objective methods (Vita Easy Shade, spectrophotometer).
temperature
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
Tooth sensitivity will be assessed by Visual Analogue Scale (VAS).

Secondary Outcome Measures

Full Information

First Posted
July 8, 2020
Last Updated
September 2, 2020
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT04537754
Brief Title
Clinical Comparison of LED- and Diode Laser-activated Bleaching
Official Title
Clinical Comparison of LED- and Diode Laser-activated Bleaching
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
June 19, 2018 (Actual)
Primary Completion Date
October 15, 2018 (Actual)
Study Completion Date
May 5, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University

4. Oversight

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

5. Study Description

Brief Summary
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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Color; Change Teeth, Posteruptive
Keywords
In-office tooth bleaching, Diode laser, LED, color change, tooth-sensitivity, temperature

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
clinician
Arm Type
Experimental
Arm Description
Comparison of LED and diode laser
Intervention Type
Device
Intervention Name(s)
bleaching device
Other Intervention Name(s)
whitness hp, FGM, Radii plus LED,SDI, Epic X, Biolase
Intervention Description
activated bleaching
Primary Outcome Measure Information:
Title
Colour change
Description
Colour change will be evaluated by subjective (Vita Classic and Vita 3D Master Bleachguide) and objective methods (Vita Easy Shade, spectrophotometer).
Time Frame
Baseline (before the treatment) and 48 hours, 1 week, 1, 6 and 9 months after.
Title
temperature
Description
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.
Time Frame
Procedure (During the bleaching treatments)
Title
Tooth sensitivity
Description
Tooth sensitivity will be assessed by Visual Analogue Scale (VAS).
Time Frame
Baseline (before the treatment) and 48 hours, 1 week, 1, 6 and 9 months after.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
A. Ruya Yazici, Prof.
Organizational Affiliation
Hacettepe University
Official's Role
Study Director
Facility Information:
Facility Name
Aybuke Uslu
City
Ankara
ZIP/Postal Code
06230
Country
Turkey

12. IPD Sharing Statement

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Clinical Comparison of LED- and Diode Laser-activated Bleaching

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