Clinical Trial of the Effect of Different Categories of Adhesive System

NCT ID: NCT02751970

Last Updated: 2016-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

185 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2018-04-30

Brief Summary

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This study aims to evaluate the clinical effectiveness of contemporary resin-based adhesive systems by retention rate of resin restorations placed in non carious cervical lesions with four different adhesive strategies: 3 and 2 steps etch-and-rinse adhesive system, 2 and 1 step self-etch adhesive systems.

Detailed Description

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The etch-and-rinse (3 and 2 steps) and self-etch (1 and 2 steps) adhesive systems allow the bond between the resins restorations with the dental substrates, but they have mechanism of action different.

The success of resin composite restorations is reliant upon adhesion to the underlying tooth via adhesive systems. The mechanism of adhesion to enamel and dentine could be involved for one hand, the etching the substrates with 30-40% phosphoric acid, followed by the application of a primer and subsequently an adhesive resin 3 steps etch-and- rinse approach or 2 steps when to combine the primer and adhesive into one bottle. For another hand, the self- etch systems with acid monomers in their primer, allow conditioning the surface without phosphoric acid step. So, they consist of either a self-etching primer accompanied by an adhesive resin applied as a subsequent step (2 steps) or a self-etch adhesive, which does not require a separate primer (1 step).

Conditions

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Dental Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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3 step ER & Dental restoration

Dental restoration with etching the dental substrates 35% phosphoric acid, followed by the application of a primer and subsequently an adhesive resin.

Group Type ACTIVE_COMPARATOR

Dental restoration

Intervention Type PROCEDURE

Methacrylate resins will be used to complement the cavity restoration after of adhesive procedure

3 step ER

Intervention Type PROCEDURE

Enamel and dentin will be conditioning with 35% phosphoric acid, then applied primer, and then applied adhesive resin.

2 step ER & Dental restoration

Dental restoration with etching the dental substrates 35% phosphoric acid, followed by the application of an adhesive/primer step.

Group Type EXPERIMENTAL

Dental restoration

Intervention Type PROCEDURE

Methacrylate resins will be used to complement the cavity restoration after of adhesive procedure

2 step ER

Intervention Type PROCEDURE

Enamel and dentin will be conditioning with 35% of phosphoric acid, then applied primer/adhesive resin.

2 step SE & Dental restoration

Dental restoration with etching the dental substrates with acidic primer, followed by the application of adhesive resin.

Group Type ACTIVE_COMPARATOR

Dental restoration

Intervention Type PROCEDURE

Methacrylate resins will be used to complement the cavity restoration after of adhesive procedure

2 step SE

Intervention Type PROCEDURE

Enamel and dentin will be conditioning with acidic primer, then applied primer/adhesive resin.

1 step SE & Dental restoration

Dental restoration with etching and infiltrate the dental substrates with acidic primer/adhesive system.

Group Type EXPERIMENTAL

Dental restoration

Intervention Type PROCEDURE

Methacrylate resins will be used to complement the cavity restoration after of adhesive procedure

1 step SE

Intervention Type PROCEDURE

Enamel and dentin will be conditioning with acidic primer/adhesive resin.

Interventions

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Dental restoration

Methacrylate resins will be used to complement the cavity restoration after of adhesive procedure

Intervention Type PROCEDURE

3 step ER

Enamel and dentin will be conditioning with 35% phosphoric acid, then applied primer, and then applied adhesive resin.

Intervention Type PROCEDURE

2 step ER

Enamel and dentin will be conditioning with 35% of phosphoric acid, then applied primer/adhesive resin.

Intervention Type PROCEDURE

2 step SE

Enamel and dentin will be conditioning with acidic primer, then applied primer/adhesive resin.

Intervention Type PROCEDURE

1 step SE

Enamel and dentin will be conditioning with acidic primer/adhesive resin.

Intervention Type PROCEDURE

Other Intervention Names

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Dental resin restoration

Eligibility Criteria

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Inclusion Criteria

* Good general health,
* Patients with acceptable oral hygiene level,
* Patients with at least 20 teeth under occlusion.
* Patients with at least four non-carious cervical lesions in four different teeth
* Patients with maximum of eight lesions that needed to be restored.
* These lesions had to be non-carious, non-retentive, deeper than 1 mm, and involve both the enamel and dentin of vital teeth without mobility.

Exclusion Criteria

* Patients with extremely poor oral hygiene,
* Patients with severe or chronic periodontitis,
* Patients with heavy bruxism habits.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidade Estadual de Ponta Grossa

OTHER

Sponsor Role collaborator

Universidad de Valparaiso

OTHER

Sponsor Role lead

Responsible Party

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Issis luque

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Issis Luque, professor

Role: PRINCIPAL_INVESTIGATOR

Pontificia Universidad Catolica de Chile

Locations

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Universidad Valparaiso

Valparaíso, Región de Valparaíso, Chile

Site Status

Countries

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Chile

References

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Chee B, Rickman LJ, Satterthwaite JD. Adhesives for the restoration of non-carious cervical lesions: a systematic review. J Dent. 2012 Jun;40(6):443-52. doi: 10.1016/j.jdent.2012.02.007. Epub 2012 Feb 18.

Reference Type BACKGROUND
PMID: 22353603 (View on PubMed)

Eliguzeloglu Dalkilic E, Omurlu H. Two-year clinical evaluation of three adhesive systems in non-carious cervical lesions. J Appl Oral Sci. 2012 Mar-Apr;20(2):192-9. doi: 10.1590/s1678-77572012000200012.

Reference Type BACKGROUND
PMID: 22666836 (View on PubMed)

Kurokawa H, Miyazaki M, Takamizawa T, Rikuta A, Tsubota K, Uekusa S. One-year clinical evaluation of five single-step self-etch adhesive systems in non-carious cervical lesions. Dent Mater J. 2007 Jan;26(1):14-20. doi: 10.4012/dmj.26.14.

Reference Type BACKGROUND
PMID: 17410888 (View on PubMed)

Scotti N, Comba A, Gambino A, Manzon E, Breschi L, Paolino D, Pasqualini D, Berutti E. Influence of operator experience on non-carious cervical lesion restorations: Clinical evaluation with different adhesive systems. Am J Dent. 2016 Feb;29(1):33-8.

Reference Type BACKGROUND
PMID: 27093774 (View on PubMed)

Moosavi H, Kimyai S, Forghani M, Khodadadi R. The clinical effectiveness of various adhesive systems: an 18-month evaluation. Oper Dent. 2013 Mar-Apr;38(2):134-41. doi: 10.2341/12-110-CR. Epub 2012 Aug 23.

Reference Type BACKGROUND
PMID: 22917442 (View on PubMed)

Heintze SD, Blunck U, Gohring TN, Rousson V. Marginal adaptation in vitro and clinical outcome of Class V restorations. Dent Mater. 2009 May;25(5):605-20. doi: 10.1016/j.dental.2008.11.004. Epub 2009 Jan 14.

Reference Type BACKGROUND
PMID: 19147216 (View on PubMed)

Peumans M, Kanumilli P, De Munck J, Van Landuyt K, Lambrechts P, Van Meerbeek B. Clinical effectiveness of contemporary adhesives: a systematic review of current clinical trials. Dent Mater. 2005 Sep;21(9):864-81. doi: 10.1016/j.dental.2005.02.003.

Reference Type BACKGROUND
PMID: 16009415 (View on PubMed)

Van Landuyt KL, Mine A, De Munck J, Jaecques S, Peumans M, Lambrechts P, Van Meerbeek B. Are one-step adhesives easier to use and better performing? Multifactorial assessment of contemporary one-step self-etching adhesives. J Adhes Dent. 2009 Jun;11(3):175-90.

Reference Type BACKGROUND
PMID: 19603581 (View on PubMed)

van Dijken JW. Clinical evaluation of three adhesive systems in class V non-carious lesions. Dent Mater. 2000 Jul;16(4):285-91. doi: 10.1016/s0109-5641(00)00019-1.

Reference Type BACKGROUND
PMID: 10831784 (View on PubMed)

Other Identifiers

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CB027-2014

Identifier Type: -

Identifier Source: org_study_id

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