Effectiveness of Office Bleaching Agents in Patients of Different Age Group

Randomized Clinical Trial Comparing the Effectiveness of Office Bleaching Agents in Patients of Different Age Group

To evaluate the effectiveness in terms of color variation, patient satisfaction, absolute risk and intensity of dentin sensitivity due to dental bleaching in the office with 35% hydrogen peroxide (Whiteness HP Automixx 35%, FGM) and Opalescence Boost 38% ( Ultradent, South Jordan, UT, USA) in the same arch in patients of different age groups: 18 to 25 years and 40 to 65 years. Data will be collected, tabulated and submitted to statistical analysis

Study Overview

• Status: Completed
• Conditions: Satisfaction
• Intervention / Treatment: Drug: Hydrogen peroxide 35%; Drug: Hydrogen peroxide 38%

Detailed Description

Throughout life, the aging of the human being as a whole is inevitable. The dental structure such as cementum and dentin undergo some changes over time, such as secondary deposition of dentin, which results in the reduction of root canal length. In addition, with aging the teeth undergo color changes, presenting a more yellowish or grayish coloration (Ravindra SV et al., 2015). The fact is that most of the studies that involve the technique of dental bleaching have as inclusion factor only young adult patients, excluding patients of more advanced age groups. Therefore, it is fundamental to evaluate the whitening technique in these older patients, since it is a treatment that does not cause harm to the individuals To assess the effect of dental bleaching in the office with Whiteness HP Automixx, FGM at 35% and Opalescence Boost at 38% in the same arch, in different age groups (18 to 25 years and 40 to 65 years) in absolute risk and intensity Of the postoperative dental sensitivity through the visual analog (VAS 0-10) and analogue (NRS 0-4) scales.

• Evaluate the efficacy of Whitening HP Automixx, FGM 35% and Opalescence Boost 38% in the same arch in different age groups (18 to 25 years and 40 to 65 years) using Color Vita Classical and Vita Bleachedguide, and the Vita Easyshade spectrophotometer.
• Evaluate the satisfaction of patients after Whitening HP Automixx at 35, FGM and Opalescence Boost 38% in the same arch in different age groups (18 to 25 years and 40 to 65 years).

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Av Pará S/n Bloco 4 L Anexo A Sala 42 Campus Umuarama
    • Uberlândia, Av Pará S/n Bloco 4 L Anexo A Sala 42 Campus Umuarama, Brazil
      • Gisele Rodrigues da Silva

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients over 18 years of age up to 25 years
• Patients aged 40 years up to 65 years
• Good oral and general health
• Teeth free of restorations or with small restorations
• Free from carious injury,
• Patients with tooth color A2 or darker according to the Vita Classical color scale (Vita Zahnfabrik, Bad Säckingen, Germany)
• Agree to the informed consent form

Exclusion Criteria:

• extensive restoration
• Patients who have already undergone dental whitening
• Pregnant or lactating women
• That report dental sensitivity
• With non-carious cervical lesion
• Parafunctional habits
• Orthodontic appliances
• Any other type of oral pathology
• Smokers, patients who are using analgesic or anti-inflammatory drugs, present systemic alterations such as gastric, cardiac, renal and hepatic problems, diabetics, hypertensives or pre-existing neoplasias.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Young Patient; With 18-25 years old. Drug: Hydrogen peroxide 35%. Drug: Hydrogen peroxide 38%	Drug: Hydrogen peroxide 35%; The office bleaching products will be applied on one of dental hemi-arch of young patients (18-25 years) or adult patients (40-65 years), after randomization. The product will apllied according manufacture instrutions.; Other Names: Hydrogen peroxide 38%; Drug: Hydrogen peroxide 38%; The office bleaching products will be applied on one of dental hemi-arch of young patients (18-25 years) or adult patients (40-65 years), after randomization. The product will apllied according manufacture instrutions.; Other Names: Hydrogen peroxide 35%
Other: Adult Patient; With 40-65 years old. Drug: Hydrogen peroxide 35%. Drug: Hydrogen peroxide 38%	Drug: Hydrogen peroxide 35%; The office bleaching products will be applied on one of dental hemi-arch of young patients (18-25 years) or adult patients (40-65 years), after randomization. The product will apllied according manufacture instrutions.; Other Names: Hydrogen peroxide 38%; Drug: Hydrogen peroxide 38%; The office bleaching products will be applied on one of dental hemi-arch of young patients (18-25 years) or adult patients (40-65 years), after randomization. The product will apllied according manufacture instrutions.; Other Names: Hydrogen peroxide 35%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tooth discoloration	Efficacy of office dental whitening mensured by Easyshade spectrophotometer.	36 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dentin sensitivity	It will analised the risk and intensity of tooth sensitivity of dental bleaching	36 weeks
Patient satisfaction	It will analised the patient satisfaction by questionnaire of self-perception of aesthetics (PIDAQ)	36 weeks

Collaborators and Investigators

• Sponsor: Federal University of Uberlandia
• Collaborators: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.; Fundação de Amparo à Pesquisa do estado de Minas Gerais
• Investigators: Principal Investigator: Gisele Silva, Dra, Federal University of Uberlandia

Publications and helpful links

General Publications

• Reis A, Dalanhol AP, Cunha TS, Kossatz S, Loguercio AD. Assessment of tooth sensitivity using a desensitizer before light-activated bleaching. Oper Dent. 2011 Jan-Feb;36(1):12-7. doi: 10.2341/10-148-CR. Epub 2011 Mar 24.
• Martin J, Rivas V, Vildosola P, Moncada L, Oliveira Junior OB, Saad JR, Fernandez E, Moncada G. Personality Style in Patients Looking for Tooth Bleaching and Its Correlation with Treatment Satisfaction. Braz Dent J. 2016 Jan-Feb;27(1):60-5. doi: 10.1590/0103-6440201600127.
• de Geus JL, Wambier LM, Kossatz S, Loguercio AD, Reis A. At-home vs In-office Bleaching: A Systematic Review and Meta-analysis. Oper Dent. 2016 Jul-Aug;41(4):341-56. doi: 10.2341/15-287-LIT. Epub 2016 Apr 5.
• Kossatz S, Dalanhol AP, Cunha T, Loguercio A, Reis A. Effect of light activation on tooth sensitivity after in-office bleaching. Oper Dent. 2011 May-Jun;36(3):251-7. doi: 10.2341/10-289-C. Epub 2011 Jul 8.

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2017
• Primary Completion (Actual): January 30, 2018
• Study Completion (Actual): January 30, 2018

Study Registration Dates

• First Submitted: May 23, 2017
• First Submitted That Met QC Criteria: June 19, 2017
• First Posted (Actual): June 22, 2017

Study Record Updates

• Last Update Posted (Actual): February 13, 2018
• Last Update Submitted That Met QC Criteria: February 9, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: dental whitening; Dental office whitening
• Additional Relevant MeSH Terms: Anti-Infective Agents, Local; Anti-Infective Agents; Hydrogen Peroxide
• Other Study ID Numbers: CAAE: 57252216.2.0000.5152

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Study Data/Documents

1. Metanalysis, systematic review
   Information identifier: 27045285
2. Clinical Study Report
   Information identifier: 21740236
3. Clinical Study Report
   Information identifier: 21488723
4. Informed Consent Form
   Information identifier: 27007348

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No