Impact of Patients Risk Factors on the Longevity of Aesthetic Restorations
NCT03834636 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 110
Last updated 2019-02-08
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
- 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).
Sponsors & Collaborators
-
Federal University of Pelotas
lead OTHER
Principal Investigators
-
Maximiliano S Cenci · Graduate Program in Dentistry - Federal University of Pelotas
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 9 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2012-01-10
- Primary Completion
- 2022-01-10
- Completion
- 2022-01-10
Countries
- Brazil
Study Locations
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