Effectiveness of Office Bleaching Agents in Patients of Different Age Group

Satisfaction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03194984
• Other study ID #: CAAE: 57252216.2.0000.5152
• Status: Completed
• Phase: N/A
• First received: May 23, 2017
• Last updated: February 9, 2018
• Start date: May 15, 2017
• Est. completion date: January 30, 2018

Study information

• Verified date: February 2018
• Source: Federal University of Uberlandia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: January 30, 2018
• Est. primary completion date: January 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Satisfaction

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	Gisele Rodrigues da Silva	Uberlândia	Av Pará S/n Bloco 4 L Anexo A Sala 42 Campus Umuarama

Sponsors (3)

Lead Sponsor	Collaborator
Federal University of Uberlandia	Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Fundação de Amparo à Pesquisa do estado de Minas Gerais

Country where clinical trial is conducted

Brazil, 

References & 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. — View Citation

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. — View Citation

Martin J, Rivas V, Vildósola 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tooth discoloration	Efficacy of office dental whitening mensured by Easyshade spectrophotometer.	36 weeks
Secondary	Dentin sensitivity	It will analised the risk and intensity of tooth sensitivity of dental bleaching	36 weeks
Secondary	Patient satisfaction	It will analised the patient satisfaction by questionnaire of self-perception of aesthetics (PIDAQ)	36 weeks