Efficacy of Laser Application in Dental Bleaching

NCT03688893 | Completed DMC

• 1 other identifier: U1111-1219-0122
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Tooth Discoloration

Keywords

Bleaching; Laser; CIELCH

Outcome Measures

Primary Outcomes (5)

• 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.

  through study completion, an average of 3 days

• 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.

  through study completion, an average of 3 days

• 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.

  through study completion, an average of 3 days

• 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.

  through study completion, an average of 3 days

• 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.

  through study completion, an average of 3 days

Secondary Outcomes (2)

• Immediate Dental Sensitivity

  through study completion, an average of 3 days

• Mediate Dental Sensitivity

  through study completion, an average of 3 days

Study Arms (2)

Laser Application

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 Laser Application and 5 minutes moving the product) from premolar to premolar in superior and inferior teeth. Experimental

Device: Laser Application for Dental Bleaching

No Laser Application

NO INTERVENTION

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

Interventions

Laser Application for Dental Bleaching DEVICE

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

Laser Application

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients who wanted to bleach or whiten their teeth.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Nacional de Caaguazu: lead

Study Sites (1)

Facultad de Odontología Universidad Nacional de Caaguazú

Coronel Oviedo, International, 595, Paraguay

Location

Related Publications (6)

• 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/

  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/

  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.

  PMID: 22783981 BACKGROUND

• 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

  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.

  PMID: 15684748 BACKGROUND

• 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.

  PMID: 20098962 BACKGROUND

MeSH Terms

Conditions

Tooth Discoloration

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Julieta M Méndez, DDs

  Facultad de Odontología Universidad Nacional de Caaguazú

  PRINCIPAL INVESTIGATOR

• Ulises A Villasanti Torales, DDs, Mgst

  Facultad de Odontología Universidad Nacional de Caaguazú

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: It was single blind; as the evaluator did not know what intervention the patient was assigned.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor in Dental Surgery, Professor of Research Methodology

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

Study Record Dates

• First Submitted: September 21, 2018
• First Posted: September 28, 2018
• Study Start: September 5, 2015
• Primary Completion: September 22, 2015
• Study Completion: September 25, 2015
• Last Updated: October 19, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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

Locations

PA (1)