NCT03834636

Impact of Patients Risk Factors on the Longevity of Aesthetic Restorations

Impact of Patients Risk Factors, Type of Dental Material and Dental Technique on the Longevity of Aesthetic Dental Restorations

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Federal University of Pelotas · Academic / Other
• Sex: All
• Age: 9 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The objective of this double-blind randomized clinical trial is to evaluate the influence of caries risk, occlusal stress and missing teeth on anterior restorations over a 10 years follow up period. 300 teeth will be randomized according to two adhesive systems: Single Bond 2 and Single Bond Universal (3M ESPE); and two composite resins: nanoparticulated (Filtek ™ Z-350- 3M ESPE) and nanohybrid (IPS Empress Direct - Ivoclar Vivadent). The randomization will be stratified according to the risk of caries and cavity type. The primary outcomes will be longevity, annual failure rate (AFR) and the success of the restorations, and the secondary outcome will be causes for restorations' failure.

Conditions

• Dental Restorations Longevity
• Dental Restoration Failure
• Esthetics, Dental

Interventions

Type	Name	Description
PROCEDURE	Restorations with nanoparticulated composites and self etch adhesives	The restorations will be placed according to the protocol developed for the care, following the guidelines of the manufacturers, with a self-etching dental adhesive (SingleBond Universal, 3M ESPE), selective enamel etching, and use of a nanoparticulated composite (Z350, 3M ESPE)
PROCEDURE	Restorations with nanoparticulated composites and total-etch adhesives	The restorations will be placed according to the protocol developed for the care, following the guidelines of the manufacturers, with a total-etching dental adhesive (SingleBond 2, 3M ESPE), and use of a nanoparticulated composite (Z350, 3M ESPE)
PROCEDURE	Restorations with nanohybrid composites and self etch adhesives	The restorations will be placed according to the protocol developed for the care, following the guidelines of the manufacturers, with a self-etching dental adhesive (SingleBond Universal, 3M ESPE), selective enamel etching, and use of a nanohybrid composite (IPS Empress Direct, Ivoclar Vivadent).
PROCEDURE	Restorations with nanohybrid composites and total-etch adhesives	The restorations will be placed according to the protocol developed for the care, following the guidelines of the manufacturers, with a total-etching dental adhesive (SingleBond 2, 3M ESPE), and use of a nanohybrid composite (IPS Empress Direct, Ivoclar Vivadent).

Timeline

• Start date: 2012-01-10
• Primary completion: 2022-01-10
• Completion: 2022-01-10
• First posted: 2019-02-08
• Last updated: 2019-02-08

Locations

1 site across 1 country: Brazil