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Efficacy of Laser Application in Dental Bleaching

Primary Purpose

Tooth Discoloration

Status
Completed
Phase
Not Applicable
Locations
Paraguay
Study Type
Interventional
Intervention
Laser Application for Dental Bleaching
Sponsored by
Universidad Nacional de Caaguazu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tooth Discoloration focused on measuring Bleaching, Laser, CIELCH

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients who wanted to bleach or whiten their teeth.

Exclusion Criteria:

  • Patients who have a color less than A2 according to the Vita Scale
  • Patients with dental sensitivity
  • caries or restorations
  • periodontal disease
  • dental abfraction or attrition
  • pregnant women, smokers
  • patients with orthodontics
  • nauseous reflects
  • patients who did not wish to sign the consent.

Sites / Locations

  • Facultad de Odontología Universidad Nacional de Caaguazú

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Laser Application

No Laser Application

Arm Description

35% Hydrogen Peroxide (Whitening HP, FGM SC Brazil) 40 minutes divided in two phases of 20 minutes each one (5 minutes colocation, 10 minutes Laser Application and 5 minutes moving the product) from premolar to premolar in superior and inferior teeth. Experimental

35% Hydrogen Peroxide (Whitening HP FGM SC Brazil), 40 minutes divided in two phases of 20 minutes each one (5 minutes colocation, 10 minutes waiting and 5 minutes moving the product) from premolar to premolar in superior and inferior teeth. No Laser Application No Intervention

Outcomes

Primary Outcome Measures

Dental Color Stage 1(Before Intervention)
The measure of the color was done to the superior canines by just one evaluator. It was done with the Vita Easyshade Spectrophotometer. To improve precision off the data, measures were taken 3 times in all superior canines studied. The Investigators used the values L, C,H.
Dental Color Stage 2 (30 minutes after dental bleaching)
The measure of the color was done to the superior canines by just one evaluator. It was done with the Vita Easyshade Spectrophotometer. To improve precision off the data, measures were taken 3 times in all superior canines studied. The Investigators used the values L, C,H.
Dental Color Stage 3 (3 days after dental bleaching)
The measure of the color was done to the superior canines by just one evaluator. It was done with the Vita Easyshade Spectrophotometer. To improve precision off the data, measures were taken 3 times in all superior canines studied. The Investigators used the values L, C,H.
Change in Color (Stage 3 - Stage 1)
The difference in color was calculated using the international accepted system CIELCh (11,18-19). The formula is ∆E* = [(∆L*)2 + (∆C*)2 + (∆h*)2] ½; were L is Luminosity, C is Chroma and h is Hue. The higher difference in color will show the better intervention.
Change in Color (Stage 2 - Stage 1)
The difference in color was calculated using the international accepted system CIELCh (11,18-19). The formula is ∆E* = [(∆L*)2 + (∆C*)2 + (∆h*)2] ½; were L is Luminosity, C is Chroma and h is Hue. The higher difference in color will show the better intervention.

Secondary Outcome Measures

Immediate Dental Sensitivity
The dental sensitivity was asked 15 minutes after bleaching using a scale: None sensitivity, light sensitivity, moderate sensitivity, severe sensitivity. Less sensitivity is going to be better.
Mediate Dental Sensitivity
The dental sensitivity was asked 3 days after bleaching using a scale: None sensitivity, light sensitivity, moderate sensitivity, severe sensitivity. Less Sensitivity is going to be better.

Full Information

First Posted
September 21, 2018
Last Updated
October 17, 2018
Sponsor
Universidad Nacional de Caaguazu
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1. Study Identification

Unique Protocol Identification Number
NCT03688893
Brief Title
Efficacy of Laser Application in Dental Bleaching
Official Title
Efficacy of Laser Application in Dental Bleaching: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
September 5, 2015 (Actual)
Primary Completion Date
September 22, 2015 (Actual)
Study Completion Date
September 25, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Nacional de Caaguazu

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.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Objective: To establish the efficacy of laser application with chemical treatment in dental bleaching compared to chemical treatment alone. Methods: The investigators conducted a randomized controlled trial (RCT), single blind (evaluator), in 24 patients randomized to laser and chemical intervention (12) or chemical intervention aloe (12). The commercial products used were Whiteness Hp 35% Hydrogen Peroxide and the LASER of DCM Equipments. The trial outcome measures were obtained using the Vita EasyShade Spectrophotometer and the International CIELCh system. To stablish differences before vs. after treatments and between groups, the T test and chi2 tests were applied.
Detailed Description
New technologies continue to be launched in the field of dental esthetics, especially for whitening, and many products advertise their efficacy. One new approach is the use of LASER technology which has been purported to be the most powerful font light for bleaching Diverse studies by different designs find different efficacies for LASER whitening Randomized clinical trials (RCT) are needed for the most rigorous confirmation of efficacy. RCT are able to control for characteristics that can cause bias, including factors related to dental care such as diet and cleaning behavior after the bleaching procedure. The investigators therefore conducted an RCT to make a side by side comparison of a LASER whitening technique with chemical bleaching versus chemical bleaching without LASER. Intervention: After the patient was informed and sign the consent; a dental prophylaxis was done. Three days later the bleaching procedure started following the same protocol regarding to the time and product used (35% Hydrogen Peroxide Whitening HP, 40 minutes divided in two phases of 20 minutes each one) from premolar to premolar in superior and inferior teeth. The difference was that one of the intervention groups used the Laser for ten minutes (starting at the minute 5) and the other did not.. The Laser used was the Whitening Lase II (DCM EQUIPMENTS). The measure of the color was done to the superior canines by just one evaluator in three stages: before bleaching (baseline), 15 minutes after bleaching, and three days after. It was done with the Vita Easyshade Spectrophotometer. The dental sensitivity also was asked at the three time points; however, as an exclusion criterion the level had to be 0 to be entered into the study. All the patients received verbal and written instructions about eating and cleaning behavior. Cleaning materials for the three days after procedure were given. As the clinical endpoint, the difference in color was calculated using the international accepted system CIELCh (11,18-19). The formula is ∆E* = [(∆L*)2 + (∆C*)2 + (∆h*)2] ½; were L is Luminosity, C is Chroma and h is Hue. A verbal numeric scale was used to determine the dental sensitivity with values from 0 to 3. The evaluator used the water and air from the dental chair syringe. The patient reports 0 for no sensitivity; 1 for slight sensitivity, 2 for moderate sensitivity, and 3 for severe sensitivity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Discoloration
Keywords
Bleaching, Laser, CIELCH

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The investigators conducted a Randomized controlled trial (RCT) to study the effect of LASER in dental bleaching in 24 patients in Paraguay in 2015.
Masking
Outcomes Assessor
Masking Description
It was single blind; as the evaluator did not know what intervention the patient was assigned.
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Laser Application
Arm Type
Experimental
Arm Description
35% Hydrogen Peroxide (Whitening HP, FGM SC Brazil) 40 minutes divided in two phases of 20 minutes each one (5 minutes colocation, 10 minutes Laser Application and 5 minutes moving the product) from premolar to premolar in superior and inferior teeth. Experimental
Arm Title
No Laser Application
Arm Type
No Intervention
Arm Description
35% Hydrogen Peroxide (Whitening HP FGM SC Brazil), 40 minutes divided in two phases of 20 minutes each one (5 minutes colocation, 10 minutes waiting and 5 minutes moving the product) from premolar to premolar in superior and inferior teeth. No Laser Application No Intervention
Intervention Type
Device
Intervention Name(s)
Laser Application for Dental Bleaching
Intervention Description
The Laser used was the Whitening Lase II (DCM EQUIPMENTS).
Primary Outcome Measure Information:
Title
Dental Color Stage 1(Before Intervention)
Description
The measure of the color was done to the superior canines by just one evaluator. It was done with the Vita Easyshade Spectrophotometer. To improve precision off the data, measures were taken 3 times in all superior canines studied. The Investigators used the values L, C,H.
Time Frame
through study completion, an average of 3 days
Title
Dental Color Stage 2 (30 minutes after dental bleaching)
Description
The measure of the color was done to the superior canines by just one evaluator. It was done with the Vita Easyshade Spectrophotometer. To improve precision off the data, measures were taken 3 times in all superior canines studied. The Investigators used the values L, C,H.
Time Frame
through study completion, an average of 3 days
Title
Dental Color Stage 3 (3 days after dental bleaching)
Description
The measure of the color was done to the superior canines by just one evaluator. It was done with the Vita Easyshade Spectrophotometer. To improve precision off the data, measures were taken 3 times in all superior canines studied. The Investigators used the values L, C,H.
Time Frame
through study completion, an average of 3 days
Title
Change in Color (Stage 3 - Stage 1)
Description
The difference in color was calculated using the international accepted system CIELCh (11,18-19). The formula is ∆E* = [(∆L*)2 + (∆C*)2 + (∆h*)2] ½; were L is Luminosity, C is Chroma and h is Hue. The higher difference in color will show the better intervention.
Time Frame
through study completion, an average of 3 days
Title
Change in Color (Stage 2 - Stage 1)
Description
The difference in color was calculated using the international accepted system CIELCh (11,18-19). The formula is ∆E* = [(∆L*)2 + (∆C*)2 + (∆h*)2] ½; were L is Luminosity, C is Chroma and h is Hue. The higher difference in color will show the better intervention.
Time Frame
through study completion, an average of 3 days
Secondary Outcome Measure Information:
Title
Immediate Dental Sensitivity
Description
The dental sensitivity was asked 15 minutes after bleaching using a scale: None sensitivity, light sensitivity, moderate sensitivity, severe sensitivity. Less sensitivity is going to be better.
Time Frame
through study completion, an average of 3 days
Title
Mediate Dental Sensitivity
Description
The dental sensitivity was asked 3 days after bleaching using a scale: None sensitivity, light sensitivity, moderate sensitivity, severe sensitivity. Less Sensitivity is going to be better.
Time Frame
through study completion, an average of 3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients who wanted to bleach or whiten their teeth. Exclusion Criteria: Patients who have a color less than A2 according to the Vita Scale Patients with dental sensitivity caries or restorations periodontal disease dental abfraction or attrition pregnant women, smokers patients with orthodontics nauseous reflects patients who did not wish to sign the consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julieta M Méndez, DDs
Organizational Affiliation
Facultad de Odontología Universidad Nacional de Caaguazú
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ulises A Villasanti Torales, DDs, Mgst
Organizational Affiliation
Facultad de Odontología Universidad Nacional de Caaguazú
Official's Role
Study Director
Facility Information:
Facility Name
Facultad de Odontología Universidad Nacional de Caaguazú
City
Coronel Oviedo
State/Province
International
ZIP/Postal Code
595
Country
Paraguay

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
By email
IPD Sharing Time Frame
From the time the protocol is available in clinicaltrials.gov and with no limit of time
IPD Sharing Access Criteria
Researchers that want to know about the study and use the protocol
Citations:
Citation
González Rosino B. Estudio clínico comparativo entre dos dispositivos de luz para blanqueamientos en clínica. 2014; [citado 17 de julio 2015]. Disponible en: http://eprints.ucm.es/27417/
Results Reference
background
Citation
Giannini M, Hirata R, Coelho AS, de Oliveira VAP, Chan DCN. Agentes Blanqueadores y Técnicas Utilizadas en Consultorio. ROBYD [Internet]. 2013 enero-abril;II(1). [citado 22 de julio 2015]. Disponible en: www.rodyb.com/agentes---blanqueadores---y---tecnicas---utilizadas---en--consultorio---27/
Results Reference
background
PubMed Identifier
22783981
Citation
Henry RK, Bauchmoyer SM, Moore W, Rashid RG. The effect of light on tooth whitening: a split-mouth design. Int J Dent Hyg. 2013 May;11(2):151-4. doi: 10.1111/j.1601-5037.2012.00568.x. Epub 2012 Jul 12.
Results Reference
background
Citation
Dostalova T, Jelinkova H, Housova D, Sulc J, Nemec M, Miyagi M, et al. Diode laser-activatedbleaching. BrazDent J. 2004;15(Special Issue):3-8. [citado 27 de marzo 2016]. Disponible en: http://blackstar.forp.usp.br/bdj/bdj15si/pdf/v15sia01.pdf
Results Reference
background
PubMed Identifier
15684748
Citation
Wetter NU, Walverde D, Kato IT, Eduardo Cde P. Bleaching efficacy of whitening agents activated by xenon lamp and 960-nm diode radiation. Photomed Laser Surg. 2004 Dec;22(6):489-93. doi: 10.1089/pho.2004.22.489.
Results Reference
background
PubMed Identifier
20098962
Citation
Alomari Q, El Daraa E. A randomized clinical trial of in-office dental bleaching with or without light activation. J Contemp Dent Pract. 2010 Jan 1;11(1):E017-24.
Results Reference
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Efficacy of Laser Application in Dental Bleaching

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