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Dental CariesPhase 2NCT02751970

Clinical Trial of the Effect of Different Categories of Adhesive System

A Phase 2 study testing Dental restoration, 3 step ER and 2 step ER in people with Dental Caries, run by Universidad de Valparaiso at 1 site in Chile.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Dental Caries
What is being tested?
Dental restoration, 3 step ER and 2 step ER
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
185 participants
Where
1 siteChile
Study dates
Apr 2014to Apr 2018
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Chile1 site

  • Universidad Valparaiso

    Valparaíso, Valparaiso, 2360004

Other trials in Chile

About this study

Official title: Randomized Clinical Trial of the Effect of Different Categories of Adhesive System

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).

Conditions
Dental Caries
Being tested
Dental restoration, 3 step ER, 2 step ER, 2 step SE, 1 step SE
Keywords
Dental adhesive, adhesive systems, Dental Restoration Failure
Medical subject headings
Dental Caries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dental restorationProcedure or surgery

    Also called Dental resin restoration

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

  • 3 step ERProcedure or surgery

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

  • 2 step ERProcedure or surgery

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

  • 2 step SEProcedure or surgery

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

  • 1 step SEProcedure or surgery

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

Study groups in NCT02751970
Study groupRoleWhat they receive
3 step ER & Dental restorationActive comparatorDental restoration with etching the dental substrates 35% phosphoric acid, followed by the application of a primer and subsequently an adhesive resin.
Receives: Procedure: Dental restoration; Procedure: 3 step ER
2 step ER & Dental restorationExperimentalDental restoration with etching the dental substrates 35% phosphoric acid, followed by the application of an adhesive/primer step.
Receives: Procedure: Dental restoration; Procedure: 2 step ER
2 step SE & Dental restorationActive comparatorDental restoration with etching the dental substrates with acidic primer, followed by the application of adhesive resin.
Receives: Procedure: Dental restoration; Procedure: 2 step SE
1 step SE & Dental restorationExperimentalDental restoration with etching and infiltrate the dental substrates with acidic primer/adhesive system.
Receives: Procedure: Dental restoration; Procedure: 1 step SE

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Secondary caries

    Secondary caries near and/or associated of the dental restorations

    Measured: one year

  2. Retention rate

    retention rate of the dental restorations

    Measured: one year

Secondary outcomes (3)

  1. Marginal integrity

    marginal integrity of the dental restorations

    Measured: one year

  2. Marginal discoloration

    Marginal discoloration of the dental restorations

    Measured: one year

  3. post-operative sensitivity

    dentin post-operative sensitivity

    Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Apr 2016 (estimated)
  2. Study startApr 2014
  3. Primary completionMay 2016 (estimated)
  4. Study completionApr 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
185 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02751970
Sponsor's protocol ID
CB027-2014
Status last verified
Apr 2016
First submitted
21 Apr 2016
Last updated
26 Apr 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dental restoration, 3 step ER and 2 step ER in people with Dental Caries, run by Universidad de Valparaiso at 1 site in Chile.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Secondary caries (time frame: one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02751970, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2016.

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