Different Application Strategies When Using Futurabond Universal in Class V Cavities

NCT03244124 | Active Not Recruiting

• 1 other identifier: UFFUEPGFUTURABOND2016
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Dental Restoration Failure of Marginal Integrity

Keywords

dentin bonding agents; tooth sensitivity; composite resin restoration

Outcome Measures

Primary Outcomes (1)

• Restoration Loss

  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 Outcomes (3)

• Marginal Pigmentation

  Four years

• Post-Operative Hypersensitivity

  Four years

• Secondary Caries

  Four years

Study Arms (4)

SET (Self-Etching)

ACTIVE COMPARATOR

50 teeth will receive restorations using Self-Etching Application Strategy

Other: Self-Etching Application Strategy

SEE (Selective Enamel Etching)

EXPERIMENTAL

50 teeth will receive restorations using Enamel Etching Application Strategy

Other: Enamel Etching Application Strategy

ERDry (Etch&Rinse Dry)

EXPERIMENTAL

50 teeth will receive restorations using Etch\&Rinse Dry Application Strategy, leaving dentin dry (but not overdry)

Other: Etch&Rinse Dry Application Strategy

ERWet (Etch&Rinse Wet)

EXPERIMENTAL

50 teeth will receive restorations using Etch\&Rinse Wet Application Strategy, leaving dentin wet

Other: Etch&Rinse Wet Application Strategy

Interventions

Self-Etching Application Strategy OTHER

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.

SET (Self-Etching)

Enamel Etching Application Strategy OTHER

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.

SEE (Selective Enamel Etching)

Etch&Rinse Dry Application Strategy OTHER

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.

ERDry (Etch&Rinse Dry)

Etch&Rinse Wet Application Strategy OTHER

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.

ERWet (Etch&Rinse Wet)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Volunteers with periodontal disease; with gingival bleeding; use of anti-inflammatory drugs in the last 30 days.

Sponsors & Collaborators

• Universidade Federal Fluminense: lead
• Universidade Estadual de Ponta Grossa: collaborator

Study Sites (2)

Universidade Estadual de Ponta Grossa

Ponta Grossa, Paraná, 84010-290, Brazil

Location

Universidade Federal Fluminense - School of Dentistry

Nova Friburgo, Rio de Janeiro, 28625-650, Brazil

Location

Related Publications (13)

• 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.

  PMID: 11445211 BACKGROUND

• 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.

  PMID: 23802645 BACKGROUND

• 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.

  PMID: 15259541 BACKGROUND

• 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.

  PMID: 19665220 BACKGROUND

• 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.

  PMID: 12537339 BACKGROUND

• 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.

  PMID: 16300826 BACKGROUND

• 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.

  PMID: 25707085 BACKGROUND

• 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.

  PMID: 27379834 BACKGROUND

• 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.

  PMID: 11137632 BACKGROUND

• 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.

  PMID: 17992913 BACKGROUND

• 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.

  PMID: 20628774 BACKGROUND

• 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.

  PMID: 16191912 BACKGROUND

• Naupari-Villasante R, Carpio-Salvatierra B, Matos TP, Tardem C, Calazans FS, Binz Ordonez MCR, Reis A, Barceleiro MO, Loguercio AD. Longevity of a single-dose, dual-cure universal adhesive: A 7.5-year double-blind split-mouth two-center randomized trial. Dent Mater. 2025 Nov 28:S0109-5641(25)00821-8. doi: 10.1016/j.dental.2025.11.015. Online ahead of print.

  PMID: 41318227 DERIVED

MeSH Terms

Conditions

Dentin Sensitivity

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• MARCOS O BARCELEIRO, DDS, PhD

  Universidade Federal Fluminense

  STUDY DIRECTOR

• ALESSANDRO D LOGUERCIO, DDS, PhD

  Universidade Estadual de Ponta Grossa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2017
• First Posted: August 9, 2017
• Study Start: September 3, 2016
• Primary Completion: May 31, 2017
• Study Completion (Estimated): November 30, 2026
• Last Updated: April 3, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)