Effectiveness of Office Bleaching Agents in Patients of Different Age Group

NCT03194984 | Completed

• 1 other identifier: CAAE: 57252216.2.0000.5152
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Satisfaction

Keywords

dental whitening; Dental office whitening

Outcome Measures

Primary Outcomes (1)

• Tooth discoloration

  Efficacy of office dental whitening mensured by Easyshade spectrophotometer.

  36 weeks

Secondary Outcomes (2)

• Dentin sensitivity

  36 weeks

• Patient satisfaction

  36 weeks

Study Arms (2)

Young Patient

OTHER

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

Drug: Hydrogen peroxide 35%; Drug: Hydrogen peroxide 38%

Adult Patient

OTHER

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

Drug: Hydrogen peroxide 35%; Drug: Hydrogen peroxide 38%

Interventions

Hydrogen peroxide 35% 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.

Also known as: Hydrogen peroxide 38%

Adult Patient; Young Patient

Hydrogen peroxide 38% 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.

Also known as: Hydrogen peroxide 35%

Adult Patient; Young Patient

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Uberlandia: lead
• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.: collaborator
• Fundação de Amparo à Pesquisa do estado de Minas Gerais: collaborator

Study Sites (1)

Gisele Rodrigues da Silva

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

Location

Related Publications (4)

• 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.

  PMID: 27045285 BACKGROUND

• 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.

  PMID: 21740236 BACKGROUND

• 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.

  PMID: 21488723 BACKGROUND

• 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.

  PMID: 27007348 BACKGROUND

MeSH Terms

Conditions

Personal Satisfaction

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Gisele Silva, Dra

  Federal University of Uberlandia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professora

Model Details: 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

Study Record Dates

• First Submitted: May 23, 2017
• First Posted: June 22, 2017
• Study Start: May 15, 2017
• Primary Completion: January 30, 2018
• Study Completion: January 30, 2018
• Last Updated: February 13, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)