Efficacy of Laser Application in Dental Bleaching

NCT ID: NCT03688893

Last Updated: 2018-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-05

Study Completion Date

2015-09-25

Brief Summary

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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

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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.

Conditions

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Tooth Discoloration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The investigators conducted a Randomized controlled trial (RCT) to study the effect of LASER in dental bleaching in 24 patients in Paraguay in 2015.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
It was single blind; as the evaluator did not know what intervention the patient was assigned.

Study Groups

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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

Group Type EXPERIMENTAL

Laser Application for Dental Bleaching

Intervention Type DEVICE

The Laser used was the Whitening Lase II (DCM EQUIPMENTS).

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Laser Application for Dental Bleaching

The Laser used was the Whitening Lase II (DCM EQUIPMENTS).

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad Nacional de Caaguazu

OTHER

Sponsor Role lead

Responsible Party

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Julieta María Méndez Romero

Doctor in Dental Surgery, Professor of Research Methodology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Julieta M Méndez, DDs

Role: PRINCIPAL_INVESTIGATOR

Facultad de Odontología Universidad Nacional de Caaguazú

Ulises A Villasanti Torales, DDs, Mgst

Role: STUDY_DIRECTOR

Facultad de Odontología Universidad Nacional de Caaguazú

Locations

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Facultad de Odontología Universidad Nacional de Caaguazú

Coronel Oviedo, International, Paraguay

Site Status

Countries

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Paraguay

References

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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/

Reference Type BACKGROUND

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/

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 22783981 (View on PubMed)

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

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 15684748 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20098962 (View on PubMed)

Other Identifiers

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U1111-1219-0122

Identifier Type: -

Identifier Source: org_study_id

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