- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03244124
Different Application Strategies When Using Futurabond Universal in Class V Cavities (FUUC)
December 13, 2023 updated by: Universidade Federal Fluminense
Clinical Evaluation of Different Application Strategies When Using a Futurabond Universal Adhesive System in Class V Cavities
Treatment clinical trial, randomized, controled, parallel, double-blinded, with four groups, that aims to evaluate the best application strategy when using a new Universal Adhesive system, Futurabond Universal (VOCO GmbH, Germany).
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 V dental restorations, made in four different ways, one from each experimental group, using the same universal self-etching adhesive system, which is the tested material in this study.
Non-carious cervical lesions will receive the applied adhesive system in 4 different protocols separated by groups.
Group Self Etching (SET) (control): 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 activated during 10 seconds with Light Emission Diode (LED) light; Group SEE (Selective enamel etching): 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 SET; Group ERDry (Etch& Rinse Dry): 37% phosphoric acid will be applied during 30 seconds, only in enamel and during 15 seconds only in dentin, in 50 teeth.
This acid will be removed using water, the cavity will be air-dried, keeping dentin dry, and then, the adhesive will be applied according to the manufacturer's instructions, as described in group SET; Group ERWet (Etch& Rinse Wet): 37% phosphoric acid will be applied during 30 seconds, only in enamel and during 15 seconds only in dentin, in 50 teeth.
This acid will be removed using water, the cavity will be air-dried, keeping dentin wet, and then, the adhesive will be applied according to the manufacturer's instructions, as described in group SET.
After applying the adhesive, the restorations will be made with composite resin, and evaluated every 6 months for pain assessment, shape, 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 new Universal Adhesive system, Futurabond Universal (VOCO GmbH, Germany).
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 Class V dental restorations, made in four different ways, one from each experimental group, using the same universal self-etching adhesive system, which is the tested material in this study.
All patients must have at only 20 teeth in function, must have at only 2 non carious cervical lesions (NCCL), in different teeth, that need restoration.
Those lesions must be non carious, must be more than 1 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.
Non-carious cervical lesions will receive the applied adhesive system in 4 different protocols separated by groups.
Group Self Etching (SET) (control): 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 activated during 10 seconds with Light Emission Diode (LED) light; Group SEE (Selective enamel etching): 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 SET; Group ERDry (Etch& Rinse Dry): 37% phosphoric acid will be applied during 30 seconds, only in enamel and during 15 seconds only in dentin, in 50 teeth.
This acid will be removed using water, the cavity will be air-dried, keeping dentin dry, and then, the adhesive will be applied according to the manufacturer's instructions, as described in group SET; Group ERWet (Etch& Rinse Wet): 37% phosphoric acid will be applied during 30 seconds, only in enamel and during 15 seconds only in dentin, in 50 teeth.
This acid will be removed using water, the cavity will be air-dried, keeping dentin wet, and then, the adhesive will be applied according to the manufacturer's instructions, as described in group SET.
After applying the adhesive, the restorations will be made with composite Admira Fusion (VOCO GmbH, Germany), and evaluated every 6 months for pain assessment, shape, 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
-
-
Paraná
-
Ponta Grossa, Paraná, Brazil, 84010-290
- Universidade Estadual de Ponta Grossa
-
-
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 2 non carious cervical lesions (NCCL), in different teeth, that need restoration. Those lesions must be non carious, must be more than 1 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: SET (Self-Etching)
50 teeth will receive restorations using Self-Etching Application Strategy
|
In Group SET, the adhesive system Futurabond Universal 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 activated during 10 seconds with LED light; After applying the adhesive, the restorations will be made with composite Admira Fusion (VOCO GmbH, Germany), and evaluated every 6 months for pain assessment, shape, staining or recurrent caries, using scores.
|
Experimental: SEE (Selective Enamel Etching)
50 teeth will receive restorations using Enamel Etching Application Strategy
|
In Group SEE, 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 system Futurabond Universal will be used in 50 teeth, according to the manufacturer's instructions.
The adhesive system will be brushed during 20 seconds in the cavity, will be air-dried during 5 seconds, and activated during 10 seconds with LED light; After applying the adhesive, the restorations will be made with composite Admira Fusion (VOCO GmbH, Germany), and evaluated every 6 months for pain assessment, shape, staining or recurrent caries, using scores.
|
Experimental: ERDry (Etch&Rinse Dry)
50 teeth will receive restorations using Etch&Rinse Dry Application Strategy, leaving dentin dry (but not overdry)
|
In Group ERDry, 37% phosphoric acid will be applied during 30 seconds, only in enamel, and 15 seconds, only in dentin, in 50 teeth.
This acid will be removed using water, the cavity will be air-dried, keeping dentin dry (but not overdry) and then, the adhesive system Futurabond Universal will be used in 50 teeth, according to the manufacturer's instructions.
The adhesive system will be brushed during 20 seconds in the cavity, will be air-dried during 5 seconds, and activated during 10 seconds with LED light; After applying the adhesive, the restorations will be made with composite Admira Fusion (VOCO GmbH, Germany), and evaluated every 6 months for pain assessment, shape, staining or recurrent caries, using scores.
|
Experimental: ERWet (Etch&Rinse Wet)
50 teeth will receive restorations using Etch&Rinse Wet Application Strategy, leaving dentin wet
|
In Group ERWet, 37% phosphoric acid will be applied during 30 seconds, only in enamel, and 15 seconds, only in dentin, in 50 teeth.
This acid will be removed using water, the cavity will be air-dried, keeping dentin wet and then, the adhesive system Futurabond Universal will be used in 50 teeth, according to the manufacturer's instructions.
The adhesive system will be brushed during 20 seconds in the cavity, will be air-dried during 5 seconds, and activated during 10 seconds with LED light; After applying the adhesive, the restorations will be made with composite Admira Fusion (VOCO GmbH, Germany), and evaluated every 6 months for pain assessment, shape, staining or recurrent caries, using scores.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Restoration Loss
Time Frame: Four years
|
It will be evaluated the increase in the number of losses of dental restorations in the period of four 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.
|
Four years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Marginal Pigmentation
Time Frame: Four years
|
It will be evaluated the increase in the number of dental restorations with marginal pigmentation in the period of four 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.
|
Four years
|
Post-Operative Hypersensitivity
Time Frame: Four years
|
It will be evaluated the increase in the number of dental restorations with dentin hypersensitivity in the period of four 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.
|
Four years
|
Secondary Caries
Time Frame: Four years
|
It will be evaluated the increase in the number of dental restorations with secondary caries in the period of four 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.
|
Four years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: ALESSANDRO D LOGUERCIO, DDS, PhD, Universidade Estadual de Ponta Grossa
- 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, 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.
- 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.
- 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.
- da Costa TR, Ferri LD, Loguercio AD, Reis A. Eighteen-month randomized clinical trial on the performance of two etch-and-rinse adhesives in non-carious cervical lesions. Am J Dent. 2014 Dec;27(6):312-7.
- Lopes LS, Calazans FS, Hidalgo R, Buitrago LL, Gutierrez F, Reis A, Loguercio AD, Barceleiro MO. Six-month Follow-up of Cervical Composite Restorations Placed With a New Universal Adhesive System: A Randomized Clinical Trial. Oper Dent. 2016 Sep-Oct;41(5):465-480. doi: 10.2341/15-309-C. Epub 2016 Jul 5.
- 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. Int Dent J. 2007 Oct;57(5):300-2. doi: 10.1111/j.1875-595x.2007.tb00136.x. No abstract available.
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)
September 3, 2016
Primary Completion (Actual)
May 31, 2017
Study Completion (Estimated)
November 30, 2024
Study Registration Dates
First Submitted
August 4, 2017
First Submitted That Met QC Criteria
August 4, 2017
First Posted (Actual)
August 9, 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
- UFFUEPGFUTURABOND2016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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