- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03343184
Clinical Evaluation of Bulk Fill Composite Restorations Associated to Universal Adhesive System (FBFSBU)
December 13, 2023 updated by: Universidade Federal Fluminense
Clinical Evaluation of Restorations With Filtek Bulk Fill, Associated With Single Bond Universal, With Different Adhesive Strategies
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.
Study Overview
Status
Active, not recruiting
Detailed 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 Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
RIO DE Janeiro
-
Nova Friburgo, RIO DE Janeiro, Brazil, 28625-650
- Universidade Federal Fluminense - School of Dentistry
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- All patients must have at only 20 teeth in function, must have at only 4 carious occlusal or proximo-occlusal lesions, or old restorations that need to be changed, in different teeth. 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.
Exclusion Criteria:
- Volunteers with periodontal disease; with gingival bleeding; use of anti-inflammatory drugs in the last 30 days.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: SEE and incremental restoration
50 teeth will receive restorations using 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.
|
Experimental: SEE and bulk restoration
50 teeth will receive restorations using 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.
|
Experimental: SET and incremental restoration
50 teeth will receive restorations using 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.
|
Experimental: SET and bulk restoration
50 teeth will receive restorations using 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Restoration Loss
Time Frame: Five years
|
It will be evaluated the increase in the number of losses of dental restorations in the period of five years, verified by periodic visual clinical examination (6/6 months) based on the statement of difference of at least 25% in the amount of remaining restorations in the different groups.
|
Five years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Marginal Pigmentation
Time Frame: Five years
|
It will be evaluated the increase in the number of dental restorations with marginal pigmentation in the period of five years, verified by periodic clinical visual examination (6/6 months) based on the statement of difference of at least 25% in the amount of stained restorations in the different groups.
|
Five years
|
Post-Operative Hypersensitivity
Time Frame: Five years
|
It will be evaluated the increase in the number of dental restorations with dentin hypersensitivity in the period of five years, verified by periodic clinical examination (6/6 months) based on the statement of difference of at least 25% in the amount of restorations with dentin hypersensitivity in the different groups.
|
Five years
|
Secondary Caries
Time Frame: Five years
|
It will be evaluated the increase in the number of dental restorations with secondary caries in the period of five years, verified by periodic radiographic examination (6/6 months) based on the statement of difference of at least 25% in the amount of restorations with secondary caries in the different groups.
|
Five years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: MARCOS O BARCELEIRO, DDS, PHD, Universidade Federal Fluminense
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Perdigao J, Kose C, Mena-Serrano AP, De Paula EA, Tay LY, Reis A, Loguercio AD. A new universal simplified adhesive: 18-month clinical evaluation. Oper Dent. 2014 Mar-Apr;39(2):113-27. doi: 10.2341/13-045-C. Epub 2013 Jun 26.
- Hickel R, Roulet JF, Bayne S, Heintze SD, Mjor IA, Peters M, Rousson V, Randall R, Schmalz G, Tyas M, Vanherle G. Recommendations for conducting controlled clinical studies of dental restorative materials. Clin Oral Investig. 2007 Mar;11(1):5-33. doi: 10.1007/s00784-006-0095-7. Epub 2007 Jan 30. Erratum In: Clin Oral Investig. 2008 Mar;12(1):97.
- Cvar JF, Ryge G. Reprint of criteria for the clinical evaluation of dental restorative materials. 1971. Clin Oral Investig. 2005 Dec;9(4):215-32. doi: 10.1007/s00784-005-0018-z. No abstract available.
- Hickel R, Peschke A, Tyas M, Mjor I, Bayne S, Peters M, Hiller KA, Randall R, Vanherle G, Heintze SD. FDI World Dental Federation: clinical criteria for the evaluation of direct and indirect restorations-update and clinical examples. Clin Oral Investig. 2010 Aug;14(4):349-66. doi: 10.1007/s00784-010-0432-8. Epub 2010 Jul 14.
- Abbas G, Fleming GJ, Harrington E, Shortall AC, Burke FJ. Cuspal movement and microleakage in premolar teeth restored with a packable composite cured in bulk or in increments. J Dent. 2003 Aug;31(6):437-44. doi: 10.1016/s0300-5712(02)00121-5.
- Moorthy A, Hogg CH, Dowling AH, Grufferty BF, Benetti AR, Fleming GJ. Cuspal deflection and microleakage in premolar teeth restored with bulk-fill flowable resin-based composite base materials. J Dent. 2012 Jun;40(6):500-5. doi: 10.1016/j.jdent.2012.02.015. Epub 2012 Mar 3.
- Roggendorf MJ, Kramer N, Appelt A, Naumann M, Frankenberger R. Marginal quality of flowable 4-mm base vs. conventionally layered resin composite. J Dent. 2011 Oct;39(10):643-7. doi: 10.1016/j.jdent.2011.07.004. Epub 2011 Jul 27.
- van Dijken JW, Pallesen U. Randomized 3-year clinical evaluation of Class I and II posterior resin restorations placed with a bulk-fill resin composite and a one-step self-etching adhesive. J Adhes Dent. 2015 Feb;17(1):81-8. doi: 10.3290/j.jad.a33502.
- Bayraktar Y, Ercan E, Hamidi MM, Colak H. One-year clinical evaluation of different types of bulk-fill composites. J Investig Clin Dent. 2017 May;8(2). doi: 10.1111/jicd.12210. Epub 2016 Jan 22.
- Pashley DH, Tay FR. Aggressiveness of contemporary self-etching adhesives. Part II: etching effects on unground enamel. Dent Mater. 2001 Sep;17(5):430-44. doi: 10.1016/s0109-5641(00)00104-4.
- Erhardt MC, Cavalcante LM, Pimenta LA. Influence of phosphoric acid pretreatment on self-etching bond strengths. J Esthet Restor Dent. 2004;16(1):33-40; discussion 41. doi: 10.1111/j.1708-8240.2004.tb00448.x.
- Erickson RL, Barkmeier WW, Latta MA. The role of etching in bonding to enamel: a comparison of self-etching and etch-and-rinse adhesive systems. Dent Mater. 2009 Nov;25(11):1459-67. doi: 10.1016/j.dental.2009.07.002. Epub 2009 Aug 7.
- Torii Y, Itou K, Nishitani Y, Ishikawa K, Suzuki K. Effect of phosphoric acid etching prior to self-etching primer application on adhesion of resin composite to enamel and dentin. Am J Dent. 2002 Oct;15(5):305-8.
- Van Landuyt KL, Peumans M, De Munck J, Lambrechts P, Van Meerbeek B. Extension of a one-step self-etch adhesive into a multi-step adhesive. Dent Mater. 2006 Jun;22(6):533-44. doi: 10.1016/j.dental.2005.05.010. Epub 2005 Nov 21.
- van Dijken JW, Pallesen U. A randomized controlled three year evaluation of "bulk-filled" posterior resin restorations based on stress decreasing resin technology. Dent Mater. 2014 Sep;30(9):e245-51. doi: 10.1016/j.dental.2014.05.028. Epub 2014 Jun 21.
- Swift EJ Jr, Perdigao J, Heymann HO, Wilder AD Jr, Bayne SC, May KN Jr, Sturdevant JR, Roberson TM. Eighteen-month clinical evaluation of a filled and unfilled dentin adhesive. J Dent. 2001 Jan;29(1):1-6. doi: 10.1016/s0300-5712(00)00050-6.
- Dalton Bittencourt D, Ezecelevski IG, Reis A, Van Dijken JW, Loguercio AD. An 18-months' evaluation of self-etch and etch & rinse adhesive in non-carious cervical lesions. Acta Odontol Scand. 2005 Jun;63(3):173-8. doi: 10.1080/00016350510019874.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2017
Primary Completion (Actual)
September 1, 2019
Study Completion (Estimated)
September 30, 2024
Study Registration Dates
First Submitted
November 10, 2017
First Submitted That Met QC Criteria
November 10, 2017
First Posted (Actual)
November 17, 2017
Study Record Updates
Last Update Posted (Estimated)
December 14, 2023
Last Update Submitted That Met QC Criteria
December 13, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- UFFNFBULKANDUNIVERSAL2017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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