NCT02751970

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
185

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2014

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

April 21, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 26, 2016

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

April 26, 2016

Status Verified

April 1, 2016

Enrollment Period

2.1 years

First QC Date

April 21, 2016

Last Update Submit

April 25, 2016

Conditions

Dental Caries

Keywords

Dental adhesiveadhesive systemsDental Restoration Failure

Outcome Measures

Primary Outcomes (2)

  • Secondary caries

    Secondary caries near and/or associated of the dental restorations

    one year

  • Retention rate

    retention rate of the dental restorations

    one year

Secondary Outcomes (3)

  • Marginal integrity

    one year

  • Marginal discoloration

    one year

  • post-operative sensitivity

    one year

Study Arms (4)

3 step ER & Dental restoration

ACTIVE COMPARATOR

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

Procedure: Dental restorationProcedure: 3 step ER

2 step ER & Dental restoration

EXPERIMENTAL

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

Procedure: Dental restorationProcedure: 2 step ER

2 step SE & Dental restoration

ACTIVE COMPARATOR

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

Procedure: Dental restorationProcedure: 2 step SE

1 step SE & Dental restoration

EXPERIMENTAL

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

Procedure: Dental restorationProcedure: 1 step SE

Interventions

Dental restorationPROCEDURE

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

Also known as: Dental resin restoration
1 step SE & Dental restoration2 step ER & Dental restoration2 step SE & Dental restoration3 step ER & Dental restoration
3 step ERPROCEDURE

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

3 step ER & Dental restoration
2 step ERPROCEDURE

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

2 step ER & Dental restoration
2 step SEPROCEDURE

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

2 step SE & Dental restoration
1 step SEPROCEDURE

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

1 step SE & Dental restoration

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients with extremely poor oral hygiene,
  • Patients with severe or chronic periodontitis,
  • Patients with heavy bruxism habits.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Valparaiso

Valparaíso, Región de Valparaíso, 2360004, Chile

Location

Related Publications (9)

  • 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.

    PMID: 22353603BACKGROUND

  • 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.

    PMID: 22666836BACKGROUND

  • 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.

    PMID: 17410888BACKGROUND

  • 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.

    PMID: 27093774BACKGROUND

  • 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.

    PMID: 22917442BACKGROUND

  • 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.

    PMID: 19147216BACKGROUND

  • 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.

    PMID: 16009415BACKGROUND

  • 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.

    PMID: 19603581BACKGROUND

  • 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.

    PMID: 10831784BACKGROUND

MeSH Terms

Conditions

Dental Caries

Interventions

SE 1-step Futurabond M

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Issis Luque, professor

    Pontificia Universidad Catolica de Chile

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 21, 2016

First Posted

April 26, 2016

Study Start

April 1, 2014

Primary Completion

May 1, 2016

Study Completion

April 1, 2018

Last Updated

April 26, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share

Locations

CL(1)