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Trial record 24 of 761 for:    region | Chile

Clinical Trial of the Effect of Different Categories of Adhesive System

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ClinicalTrials.gov Identifier: NCT02751970
Recruitment Status : Unknown
Verified April 2016 by Issis luque, Universidad de Valparaiso.
Recruitment status was:  Active, not recruiting
First Posted : April 26, 2016
Last Update Posted : April 26, 2016
Sponsor:
Collaborator:
Universidade Estadual de Ponta Grossa
Information provided by (Responsible Party):
Issis luque, Universidad de Valparaiso

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.

Condition or disease Intervention/treatment Phase
Dental Caries Procedure: Dental restoration Procedure: 3 step ER Procedure: 2 step ER Procedure: 2 step SE Procedure: 1 step SE Phase 2

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 185 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial of the Effect of Different Categories of Adhesive System
Study Start Date : April 2014
Estimated Primary Completion Date : May 2016
Estimated Study Completion Date : April 2018

Arm Intervention/treatment
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
Methacrylate resins will be used to complement the cavity restoration after of adhesive procedure
Other Name: Dental resin restoration

Procedure: 3 step ER
Enamel and dentin will be conditioning with 35% phosphoric acid, then applied primer, and then applied adhesive resin.

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
Methacrylate resins will be used to complement the cavity restoration after of adhesive procedure
Other Name: Dental resin restoration

Procedure: 2 step ER
Enamel and dentin will be conditioning with 35% of phosphoric acid, then applied primer/adhesive resin.

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
Methacrylate resins will be used to complement the cavity restoration after of adhesive procedure
Other Name: Dental resin restoration

Procedure: 2 step SE
Enamel and dentin will be conditioning with acidic primer, then applied primer/adhesive resin.

Experimental: 1 step SE & Dental restoration
Dental restoration with etching and infiltrate the dental substrates with acidic primer/adhesive system.
Procedure: Dental restoration
Methacrylate resins will be used to complement the cavity restoration after of adhesive procedure
Other Name: Dental resin restoration

Procedure: 1 step SE
Enamel and dentin will be conditioning with acidic primer/adhesive resin.




Primary Outcome Measures :
  1. Secondary caries [ Time Frame: one year ]
    Secondary caries near and/or associated of the dental restorations

  2. Retention rate [ Time Frame: one year ]
    retention rate of the dental restorations


Secondary Outcome Measures :
  1. Marginal integrity [ Time Frame: one year ]
    marginal integrity of the dental restorations

  2. Marginal discoloration [ Time Frame: one year ]
    Marginal discoloration of the dental restorations

  3. post-operative sensitivity [ Time Frame: one year ]
    dentin post-operative sensitivity



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02751970


Locations
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Chile
Universidad Valparaiso
Valparaiso, V region, Chile, 2360004
Sponsors and Collaborators
Universidad de Valparaiso
Universidade Estadual de Ponta Grossa
Investigators
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Principal Investigator: Issis Luque, professor Pontificia Universidad Catolica de Chile

Publications:

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Responsible Party: Issis luque, Professor, Universidad de Valparaiso
ClinicalTrials.gov Identifier: NCT02751970     History of Changes
Other Study ID Numbers: CB027-2014
First Posted: April 26, 2016    Key Record Dates
Last Update Posted: April 26, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Issis luque, Universidad de Valparaiso:
Dental adhesive
adhesive systems
Dental Restoration Failure

Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases