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Clinical Trial of the Effect of Different Categories of Adhesive System

Primary Purpose

Dental Caries

Status
Unknown status
Phase
Phase 2
Locations
Chile
Study Type
Interventional
Intervention
Dental restoration
3 step ER
2 step ER
2 step SE
1 step SE
Sponsored by
Universidad de Valparaiso
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries focused on measuring Dental adhesive, adhesive systems, Dental Restoration Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Universidad Valparaiso

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Active Comparator

Experimental

Arm Label

3 step ER & Dental restoration

2 step ER & Dental restoration

2 step SE & Dental restoration

1 step SE & Dental restoration

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Secondary caries
Secondary caries near and/or associated of the dental restorations
Retention rate
retention rate of the dental restorations

Secondary Outcome Measures

Marginal integrity
marginal integrity of the dental restorations
Marginal discoloration
Marginal discoloration of the dental restorations
post-operative sensitivity
dentin post-operative sensitivity

Full Information

First Posted
April 21, 2016
Last Updated
April 25, 2016
Sponsor
Universidad de Valparaiso
Collaborators
Universidade Estadual de Ponta Grossa
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1. Study Identification

Unique Protocol Identification Number
NCT02751970
Brief Title
Clinical Trial of the Effect of Different Categories of Adhesive System
Official Title
Randomized Clinical Trial of the Effect of Different Categories of Adhesive System
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2014 (undefined)
Primary Completion Date
May 2016 (Anticipated)
Study Completion Date
April 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Valparaiso
Collaborators
Universidade Estadual de Ponta Grossa

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
Keywords
Dental adhesive, adhesive systems, Dental Restoration Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
185 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
3 step ER & Dental restoration
Arm Type
Active Comparator
Arm Description
Dental restoration with etching the dental substrates 35% phosphoric acid, followed by the application of a primer and subsequently an adhesive resin.
Arm Title
2 step ER & Dental restoration
Arm Type
Experimental
Arm Description
Dental restoration with etching the dental substrates 35% phosphoric acid, followed by the application of an adhesive/primer step.
Arm Title
2 step SE & Dental restoration
Arm Type
Active Comparator
Arm Description
Dental restoration with etching the dental substrates with acidic primer, followed by the application of adhesive resin.
Arm Title
1 step SE & Dental restoration
Arm Type
Experimental
Arm Description
Dental restoration with etching and infiltrate the dental substrates with acidic primer/adhesive system.
Intervention Type
Procedure
Intervention Name(s)
Dental restoration
Other Intervention Name(s)
Dental resin restoration
Intervention Description
Methacrylate resins will be used to complement the cavity restoration after of adhesive procedure
Intervention Type
Procedure
Intervention Name(s)
3 step ER
Intervention Description
Enamel and dentin will be conditioning with 35% phosphoric acid, then applied primer, and then applied adhesive resin.
Intervention Type
Procedure
Intervention Name(s)
2 step ER
Intervention Description
Enamel and dentin will be conditioning with 35% of phosphoric acid, then applied primer/adhesive resin.
Intervention Type
Procedure
Intervention Name(s)
2 step SE
Intervention Description
Enamel and dentin will be conditioning with acidic primer, then applied primer/adhesive resin.
Intervention Type
Procedure
Intervention Name(s)
1 step SE
Intervention Description
Enamel and dentin will be conditioning with acidic primer/adhesive resin.
Primary Outcome Measure Information:
Title
Secondary caries
Description
Secondary caries near and/or associated of the dental restorations
Time Frame
one year
Title
Retention rate
Description
retention rate of the dental restorations
Time Frame
one year
Secondary Outcome Measure Information:
Title
Marginal integrity
Description
marginal integrity of the dental restorations
Time Frame
one year
Title
Marginal discoloration
Description
Marginal discoloration of the dental restorations
Time Frame
one year
Title
post-operative sensitivity
Description
dentin post-operative sensitivity
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Issis Luque, professor
Organizational Affiliation
Pontificia Universidad Catolica de Chile
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad Valparaiso
City
Valparaiso
State/Province
V region
ZIP/Postal Code
2360004
Country
Chile

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22353603
Citation
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.
Results Reference
background
PubMed Identifier
22666836
Citation
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.
Results Reference
background
PubMed Identifier
17410888
Citation
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.
Results Reference
background
PubMed Identifier
27093774
Citation
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.
Results Reference
background
PubMed Identifier
22917442
Citation
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.
Results Reference
background
PubMed Identifier
19147216
Citation
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.
Results Reference
background
PubMed Identifier
16009415
Citation
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.
Results Reference
background
PubMed Identifier
19603581
Citation
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.
Results Reference
background
PubMed Identifier
10831784
Citation
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.
Results Reference
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Clinical Trial of the Effect of Different Categories of Adhesive System

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