Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy of Laser Application in Dental Bleaching

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03688893
Recruitment Status : Completed
First Posted : September 28, 2018
Last Update Posted : October 19, 2018
Sponsor:
Information provided by (Responsible Party):
Julieta María Méndez Romero, Universidad Nacional de Caaguazu

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.


Condition or disease Intervention/treatment Phase
Tooth Discoloration Device: Laser Application for Dental Bleaching Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Single (Outcomes Assessor)
Masking Description: It was single blind; as the evaluator did not know what intervention the patient was assigned.
Primary Purpose: Treatment
Official Title: Efficacy of Laser Application in Dental Bleaching: A Randomized Clinical Trial
Actual Study Start Date : September 5, 2015
Actual Primary Completion Date : September 22, 2015
Actual Study Completion Date : September 25, 2015

Arm Intervention/treatment
Experimental: Laser Application
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
Device: Laser Application for Dental Bleaching
The Laser used was the Whitening Lase II (DCM EQUIPMENTS).

No Intervention: No Laser Application
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



Primary Outcome Measures :
  1. Dental Color Stage 1(Before Intervention) [ Time Frame: through study completion, an average of 3 days ]
    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.

  2. Dental Color Stage 2 (30 minutes after dental bleaching) [ Time Frame: through study completion, an average of 3 days ]
    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.

  3. Dental Color Stage 3 (3 days after dental bleaching) [ Time Frame: through study completion, an average of 3 days ]
    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.

  4. Change in Color (Stage 3 - Stage 1) [ Time Frame: through study completion, an average of 3 days ]
    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.

  5. Change in Color (Stage 2 - Stage 1) [ Time Frame: through study completion, an average of 3 days ]
    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 :
  1. Immediate Dental Sensitivity [ Time Frame: through study completion, an average of 3 days ]
    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.

  2. Mediate Dental Sensitivity [ Time Frame: through study completion, an average of 3 days ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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): NCT03688893


Locations
Layout table for location information
Paraguay
Facultad de Odontología Universidad Nacional de Caaguazú
Coronel Oviedo, International, Paraguay, 595
Sponsors and Collaborators
Universidad Nacional de Caaguazu
Investigators
Layout table for investigator information
Principal Investigator: Julieta M Méndez, DDs Facultad de Odontología Universidad Nacional de Caaguazú
Study Director: Ulises A Villasanti Torales, DDs, Mgst Facultad de Odontología Universidad Nacional de Caaguazú
Publications:
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/
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/
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

Layout table for additonal information
Responsible Party: Julieta María Méndez Romero, Doctor in Dental Surgery, Professor of Research Methodology, Universidad Nacional de Caaguazu
ClinicalTrials.gov Identifier: NCT03688893    
Other Study ID Numbers: U1111-1219-0122
First Posted: September 28, 2018    Key Record Dates
Last Update Posted: October 19, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: By email
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: From the time the protocol is available in clinicaltrials.gov and with no limit of time
Access Criteria: Researchers that want to know about the study and use the protocol

Layout table for additional information
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
Keywords provided by Julieta María Méndez Romero, Universidad Nacional de Caaguazu:
Bleaching
Laser
CIELCH
Additional relevant MeSH terms:
Layout table for MeSH terms
Tooth Discoloration
Tooth Diseases
Stomatognathic Diseases