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Clinical Evaluation of Bulk Fill Composite Restorations Associated to Universal Adhesive System
Sponsor: Universidade Federal Fluminense
Summary
Treatment clinical trial, randomized, controled, parallel, double-blinded, with four groups, that aims to evaluate the best application strategy when using a Universal Adhesive system, Single Bond Universal (3M ESPE, USA), in self-etch application mode, with or without enamel etching, associated wity a Bulk Fill Composite (Filtek Bulk Fill, 3M ESPE, USA), or with a conventional nanofilled composite (Filtek Z350 XT, 3M ESPE). Volunteers will be selected and recruited,following inclusion criteria and pre-established exclusion. All volunteers will be informed and sign a term of clarification and consent. 50 enrolled patients will receive 200 Class I or Class II dental restorations, made in four different ways, one from each experimental group, using the same universal self-etching adhesive system, with two application strategies, under the restorations that will use two different composites, a bulk fill composite, used in the bulk strategy, or a nanofilled composite, used in the traditional incremental strategy. Occlusal or Proximo-occlusal lesions will receive the selected adhesive system in 2 different protocols separated by groups. Group Self Etching and Bulk Fill (SETB), Group Selective enamel etching and Bulk Fill (SEEB), Group Self Etching and Filtek Z350XT (SETI), and Group Selective enamel etching and Filtek Z350XT (SEEI).Total time used in the restorations will be evaluated during the restorations. Immediate post-operative tooth sensitivity will be evaluated after one week. Restorations will be evaluated every 6 months for pain assessment, shape, fractures, staining or recurrent caries, using scores. To determine in which group each tooth will be enrolled, the authors will randomize the teeth.
Official title: Clinical Evaluation of Restorations With Filtek Bulk Fill, Associated With Single Bond Universal, With Different Adhesive Strategies
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2017-06-01
Completion Date
2026-09-30
Last Updated
2025-04-03
Healthy Volunteers
Yes
Interventions
SEE Strategy and Incremental Restoration
37% phosphoric acid will be applied during 30 seconds, only in enamel in 50 teeth. This acid will be removed using water, the cavity will be air-dried, and then, the adhesive will be brushed during 20 seconds in the cavity, will be air-dried during 5 seconds, and photoactivated during 10 seconds with Light Emission Diode (LED) light. Then, the Filtek Z350XT composite will be used in increments of no more than 2 mm, using the incremental restoration technique, and each increment will be photoactivated for 40 seconds.
SEE Strategy and Bulk Fill Restoration
37% phosphoric acid will be applied during 30 seconds, only in enamel in 50 teeth. This acid will be removed using water, the cavity will be air-dried, and then, the adhesive will be brushed during 20 seconds in the cavity, will be air-dried during 5 seconds, and photoactivated during 10 seconds with Light Emission Diode (LED) light. Then, the Filtek Bulk Fill composite will be used in increments of 4 mm, using the bulk restoration technique, and photoactivated for 40 seconds.
SET Strategy and Incremental Restoration
no conditioning, the adhesive system will be used in 50 teeth, according to the manufacturer's instructions, in the self-etching mode. The adhesive system will be brushed during 20 seconds in the cavity, will be air-dried during 5 seconds, and photoactivated during 10 seconds with Light Emission Diode (LED) light. Then, the Filtek Z350XT composite will be used in increments of no more than 2 mm, using the incremental restoration technique, and each increment will be photoactivated for 40 seconds.
SET Strategy and Bulk Fill Restoration
no conditioning, the adhesive system will be used in 50 teeth, according to the manufacturer's instructions, in the self-etching mode. The adhesive system will be brushed during 20 seconds in the cavity, will be air-dried during 5 seconds, and photoactivated during 10 seconds with Light Emission Diode (LED) light. Then, the Filtek Bulk Fill composite will be used in increments of 4 mm, using the bulk restoration technique, and photoactivated for 40 seconds.
Locations (1)
Universidade Federal Fluminense - School of Dentistry
Nova Friburgo, Rio de Janeiro, Brazil