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Status unknownNCT02751970Updated Apr 26, 2016

Clinical Trial of the Effect of Different Categories of Adhesive System

A Phase 2 interventional study of Dental restoration and 3 step ER in Dental Caries, sponsored by Universidad de Valparaiso. Status unknown at 1 site in Chile. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-04-26.

Sponsored by Universidad de Valparaiso · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2016), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
185
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

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).

02

Conditions studied

  • Dental Caries

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Keywords

  • Dental adhesive
  • adhesive systems
  • Dental Restoration Failure
03

In context

Dental Caries

1,109 studies on the registry are indexed under Dental Caries; 197 are open to participants now.

This study's planned enrollment of 185 is above the median of 60 across 916 interventional studies indexed under Dental Caries.

Browse Dental Caries studies →

Lead sponsor

Universidad de Valparaiso is the lead sponsor of 28 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Patients with extremely poor oral hygiene,
  • Patients with severe or chronic periodontitis,
  • Patients with heavy bruxism habits.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
185 participants (estimated)

Study arms

  • Active comparator
    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.

    Procedure: Dental restoration · Procedure: 3 step ER

  • Experimental
    2 step ER & Dental restoration

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

    Procedure: Dental restoration · Procedure: 2 step ER

  • Active comparator
    2 step SE & Dental restoration

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

    Procedure: Dental restoration · Procedure: 2 step SE

  • Experimental
    1 step SE & Dental restoration

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

    Procedure: Dental restoration · Procedure: 1 step SE

Interventions

  • ProcedureDental restoration

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

    Also known as: Dental resin restoration

  • Procedure3 step ER

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

  • Procedure2 step ER

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

  • Procedure2 step SE

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

  • Procedure1 step SE

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

06

What researchers measure

Primary outcomes

  1. Secondary caries

    Secondary caries near and/or associated of the dental restorations

    Time frame: one year

  2. Retention rate

    retention rate of the dental restorations

    Time frame: one year

Secondary outcomes

  1. Marginal integrity

    marginal integrity of the dental restorations

    Time frame: one year

  2. Marginal discoloration

    Marginal discoloration of the dental restorations

    Time frame: one year

  3. post-operative sensitivity

    dentin post-operative sensitivity

    Time frame: one year

07

Study locations

1 site
  • Universidad Valparaiso
    Valparaiso, V region 2360004, Chile
08

References and documents

Publications

  • 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. PubMed 22353603 ↗
  • 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. PubMed 22666836 ↗
  • 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. PubMed 17410888 ↗
  • 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. PubMed 27093774 ↗
  • 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. PubMed 22917442 ↗
  • 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. PubMed 19147216 ↗
  • 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. PubMed 16009415 ↗
  • 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. PubMed 19603581 ↗
  • 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. PubMed 10831784 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 26, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02751970
Lead sponsor
Universidad de Valparaiso
Collaborators
Universidade Estadual de Ponta Grossa
Responsible party
Issis luque (Professor, Universidad de Valparaiso) — Principal investigator
First posted
Apr 26, 2016
Start date
Apr 2014
Primary completion
May 2016 (estimated)
Completion
Apr 2018 (estimated)
Last update
Apr 26, 2016

Study contacts

Issis Luque, professor
principal investigator · Pontificia Universidad Catolica de Chile

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

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