Effectiveness of Office Bleaching Agents in Patients of Different Age Group

NCT ID: NCT03194984

Last Updated: 2018-02-13

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

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-15

Study Completion Date

2018-01-30

Brief Summary

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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

Detailed Description

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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).

Conditions

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Satisfaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

range of patients aged 18 to 25 years receiving two types of geis and range of patients aged 40-65 years receiving two types of geis
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
the patient did not know in which region each gel was applied the investigator did not know in which region each gel was applied the outcomes assessor did not know in which region each gel was applied

Study Groups

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Young Patient

With 18-25 years old. Drug: Hydrogen peroxide 35%. Drug: Hydrogen peroxide 38%

Group Type OTHER

Hydrogen peroxide 35%

Intervention Type DRUG

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.

Hydrogen peroxide 38%

Intervention Type DRUG

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.

Adult Patient

With 40-65 years old. Drug: Hydrogen peroxide 35%. Drug: Hydrogen peroxide 38%

Group Type OTHER

Hydrogen peroxide 35%

Intervention Type DRUG

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.

Hydrogen peroxide 38%

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Hydrogen peroxide 38% Hydrogen peroxide 35%

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

OTHER_GOV

Sponsor Role collaborator

Fundação de Amparo à Pesquisa do estado de Minas Gerais

OTHER

Sponsor Role collaborator

Federal University of Uberlandia

OTHER

Sponsor Role lead

Responsible Party

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Gisele Rodrigues da Silva

professora

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gisele Silva, Dra

Role: PRINCIPAL_INVESTIGATOR

Federal University of Uberlandia

Locations

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Gisele Rodrigues da Silva

Uberlândia, Av Pará S/n Bloco 4 L Anexo A Sala 42 Campus Umuarama, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type BACKGROUND
PMID: 27045285 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21740236 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21488723 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27007348 (View on PubMed)

Study Documents

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Document Type: Metanalysis, systematic review

View Document

Document Type: Clinical Study Report

View Document

Document Type: Clinical Study Report

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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CAAE: 57252216.2.0000.5152

Identifier Type: -

Identifier Source: org_study_id

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