Clinical Trial of the Effect of Different Categories of Adhesive System
April 25, 2016 updated by: Issis luque, Universidad de Valparaiso
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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).
Study Type
Interventional
Enrollment (Anticipated)
185
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
V region
-
Valparaiso, V region, Chile, 2360004
- Universidad Valparaiso
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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.
|
Methacrylate resins will be used to complement the cavity restoration after of adhesive procedure
Other Names:
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.
|
Methacrylate resins will be used to complement the cavity restoration after of adhesive procedure
Other Names:
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.
|
Methacrylate resins will be used to complement the cavity restoration after of adhesive procedure
Other Names:
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.
|
Methacrylate resins will be used to complement the cavity restoration after of adhesive procedure
Other Names:
Enamel and dentin will be conditioning with acidic primer/adhesive resin.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Secondary caries
Time Frame: one year
|
Secondary caries near and/or associated of the dental restorations
|
one year
|
|
Retention rate
Time Frame: one year
|
retention rate of the dental restorations
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Marginal integrity
Time Frame: one year
|
marginal integrity of the dental restorations
|
one year
|
|
Marginal discoloration
Time Frame: one year
|
Marginal discoloration of the dental restorations
|
one year
|
|
post-operative sensitivity
Time Frame: one year
|
dentin post-operative sensitivity
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Issis Luque, professor, Pontificia Universidad Católica de Chile
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2014
Primary Completion (Anticipated)
May 1, 2016
Study Completion (Anticipated)
April 1, 2018
Study Registration Dates
First Submitted
April 21, 2016
First Submitted That Met QC Criteria
April 25, 2016
First Posted (Estimate)
April 26, 2016
Study Record Updates
Last Update Posted (Estimate)
April 26, 2016
Last Update Submitted That Met QC Criteria
April 25, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CB027-2014
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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