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Effectiveness of Office Bleaching Agents in Patients of Different Age Group

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ClinicalTrials.gov Identifier: NCT03194984
Recruitment Status : Completed
First Posted : June 22, 2017
Last Update Posted : February 13, 2018
Sponsor:
Collaborators:
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Fundação de Amparo à Pesquisa do estado de Minas Gerais
Information provided by (Responsible Party):
Gisele Rodrigues da Silva, Federal University of Uberlandia

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

Condition or disease Intervention/treatment Phase
Satisfaction Drug: Hydrogen peroxide 35% Drug: Hydrogen peroxide 38% Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: 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
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial Comparing the Effectiveness of Office Bleaching Agents in Patients of Different Age Group
Actual Study Start Date : May 15, 2017
Actual Primary Completion Date : January 30, 2018
Actual Study Completion Date : January 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 Name: 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 Name: Hydrogen peroxide 35%

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 Name: 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 Name: Hydrogen peroxide 35%




Primary Outcome Measures :
  1. Tooth discoloration [ Time Frame: 36 weeks ]
    Efficacy of office dental whitening mensured by Easyshade spectrophotometer.


Secondary Outcome Measures :
  1. Dentin sensitivity [ Time Frame: 36 weeks ]
    It will analised the risk and intensity of tooth sensitivity of dental bleaching

  2. Patient satisfaction [ Time Frame: 36 weeks ]
    It will analised the patient satisfaction by questionnaire of self-perception of aesthetics (PIDAQ)



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03194984


Locations
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Brazil
Gisele Rodrigues da Silva
Uberlândia, Av Pará S/n Bloco 4 L Anexo A Sala 42 Campus Umuarama, Brazil
Sponsors and Collaborators
Federal University of Uberlandia
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Fundação de Amparo à Pesquisa do estado de Minas Gerais
Investigators
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Principal Investigator: Gisele Silva, Dra Federal University of Uberlandia

Study Data/Documents: Metanalysis, systematic review  This link exits the ClinicalTrials.gov site
Identifier: 27045285
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 21740236
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 21488723
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 27007348

Publications:
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Responsible Party: Gisele Rodrigues da Silva, professora, Federal University of Uberlandia
ClinicalTrials.gov Identifier: NCT03194984     History of Changes
Other Study ID Numbers: CAAE: 57252216.2.0000.5152
First Posted: June 22, 2017    Key Record Dates
Last Update Posted: February 13, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gisele Rodrigues da Silva, Federal University of Uberlandia:
dental whitening
Dental office whitening
Additional relevant MeSH terms:
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Hydrogen Peroxide
Anti-Infective Agents, Local
Anti-Infective Agents