A Phase 3 interventional study of Restorations with nanoparticulated composites and self etch adhesives and Restorations with nanoparticulated composites and total-etch adhesives in Dental Restorations Longevity, Dental Restoration Failure and Esthetics, Dental, sponsored by Federal University of Pelotas. Status unknown at 1 site in Brazil. Open to participants aged 9 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-08.
Sponsored by Federal University of Pelotas · Phase 3, Interventional, and Treatment
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.
Federal University of Pelotas is the lead sponsor of 52 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Procedure: Restorations with nanoparticulated composites and self etch adhesives
Procedure: Restorations with nanoparticulated composites and total-etch adhesives
Procedure: Restorations with nanohybrid composites and self etch adhesives
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 self-etching dental adhesive (SingleBond Universal, 3M ESPE), selective enamel etching, and use of a nanoparticulated composite (Z350, 3M ESPE)
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)
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).
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).
Survival of the restorations
Survival of the restoration is defined as any case where the restoration remains functional in the mouth at the time of evaluation, regardless of need of small interventions, such as repair or refurbishment. The restorations were evaluated shortly after baseline and in prospective periods through a direct clinical inspection, with an explorer probe and a clinical mirror, according to the criteria for clinical evaluation of restorations proposed by the FDI (International Dental Federation) (Hickel et al., 2010), the risks of caries and occlusal stress were also evaluated again. Two trained and calibrated evaluators, unrelated to making the restorations, blinded to the type of material used, independently performed the clinical evaluations.
Time frame: Changes in the dental restorations status compared to baseline will be assessed yearly up to 10 years.
Success of the restorations
Success of the restoration is defined as any case where the restoration remains functional in the mouth at the time of evaluation, without any need of new interventions, and attending the patients demands. The restorations were evaluated shortly after baseline and in prospective periods through a direct clinical inspection, with an explorer probe and a clinical mirror, according to the criteria for clinical evaluation of restorations proposed by the FDI (International Dental Federation) (Hickel et al., 2010), the risks of caries and occlusal stress were also evaluated again.
Time frame: Changes in the dental restorations status compared to baseline will be assessed yearly up to 10 years.
Patient satisfaction with the treatment
Patient satisfaction will be recorded with FDI criteria
Time frame: Changes in the patient's satisfaction status compared to baseline will be assessed yearly up to 10 years.
Plan to share: Undecided
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This study is status unknown, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Federal University of Pelotas