Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

This is a Treatment clinical trial, randomized, controlled, 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. All 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. All patients must have at only 20 teeth in function, must have at only 4 carious lesion in occlusal or proximo-occlusal face in posterior teeth or old restorations in the same faces, with problems, that need to be changed. Those lesions must be more than 2 mm deep, should have exposed dentin, and must have at only 50% of margins in enamel. Teeth should not present periodontal mobility. Firstly, the patient will be anesthetized locally with 3% Mepivacaine solution, followed by prophylaxis with pumice powder and water. All cavities will be washed and dried after these procedures for optimal selection of color, using a color scale. Then, the rubber dam isolation of the teeth to be restored will be held. 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): 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; Group Selective enamel etching and Bulk Fill (SEEB): 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 applied according to the manufacturer's instructions, as described in group SETB. Restorations will also be made as described in group SETB; Group Self Etching and Filtek Z350XT (SETI): 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.; Group Selective enamel etching and Filtek Z350XT (SEEI): 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 applied according to the manufacturer's instructions, as described in group SETI. Restorations will also be made as described in group SETI. 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. ;


Study Design


Related Conditions & MeSH terms

  • Dental Restoration Failure of Marginal Integrity

NCT number NCT03343184
Study type Interventional
Source Universidade Federal Fluminense
Contact
Status Active, not recruiting
Phase N/A
Start date June 1, 2017
Completion date September 30, 2024

See also
  Status Clinical Trial Phase
Active, not recruiting NCT03244124 - Different Application Strategies When Using Futurabond Universal in Class V Cavities N/A
Enrolling by invitation NCT04630587 - Longevity of Dental Fillings Utilizing 3D Printing N/A
Active, not recruiting NCT03657862 - Outcomes of Restoring Untreated and SDF-treated Dentine Caries Lesions in Primary Teeth of Preschool Children N/A
Not yet recruiting NCT03645551 - Clinical Longevity of Ceramic Laminate Veneers
Recruiting NCT04838483 - Clinical Performance of Posterior Indirect Adhesive Restorations N/A
Withdrawn NCT03933176 - Absence of Liner Following the Selective Caries Removal (ALFSCaRe) N/A
Not yet recruiting NCT06392685 - Composite Repair Using Silane Coupling Agent N/A
Enrolling by invitation NCT03517124 - Ceramic Tooth Restorations - a Comparison Study N/A
Completed NCT06456619 - CAD-CAM or Adhesive Approaches for MIH Treatment N/A
Completed NCT05125900 - Clinical Evaluation of Subgingival Open Sandwich Restorations N/A
Completed NCT03515265 - Clinical Performance of Fiber Reinforced Composite Versus Microhybrid Composite Restorations N/A
Completed NCT03283280 - Clinical Performance of Short Fiber Reinforced Resin Composite Versus Indirect Nanohybrid Resin Composite Onlay Restorations. N/A
Terminated NCT02572570 - Clinical Investigation of a New Bulk Fill Composite Resin in the Restoration of Posterior Teeth N/A
Recruiting NCT06164418 - Comparative Evaluation of Class V Restorations N/A
Recruiting NCT04293770 - Clinical Evaluation of Posterior Indirect Adhesive Restorations N/A
Active, not recruiting NCT06183320 - Can Flowable Bulk Fill Composites be Used in Proximal Area of Class II Restorations N/A
Completed NCT04306549 - Twenty-Four-Month Clinical Comparison of Two Bulk-Fill and Microhybrid Composite Restorations N/A
Completed NCT05551130 - Could Bulk Fill Glass Hybrid Restorative Materials Replace Composite Resins in Treating Permanent Teeth? N/A
Active, not recruiting NCT03924830 - Influence of Surface Sealants on the Quality of Posterior Restorations With Bulk Fill Composites N/A
Completed NCT02948686 - Different Application Strategies When Using Ambar Universal in Class V Cavities N/A