Clinical Evaluation of Bulk-fill vs Layered Composite Resin in Class I and II Posterior Restorations
NCT ID: NCT03306602
Last Updated: 2017-10-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2017-01-30
2019-04-10
Brief Summary
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Detailed Description
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This approach to restore teeth has a number of advantages, for example, it results in better light penetration and better polymerization of composite resin, reduction in cavity configuration factor, reduction in polymerization shrinkage stress and ensures that the resin adheres to the cavity walls. During curing of the resin, a network of polymers is formed, which becomes rigid due to increased cross linking of the polymer chains. Decreasing mobility of the network causes further shrinkage and results in a strain on the resin composite and cavity margins. The resulting stress has been associated with marginal deficiencies, enamel fractures, cuspal movement, and cracked cusps, which in turn may result in microleakage, post-operative sensitivity, and secondary caries. It has been stated that posterior class II and especially class I cavities with a high C-factor will result in greater stresses due to a larger number of bonded surfaces.
However, there are number of disadvantages associated with the use of an incremental approach to place the resin. For example, voids can be trapped in between the increments, bonding failure can occur in between the increments, difficulty in placing the composite material after cavity preparation and the long time taken for the procedure. In an effort to counter these problems, a new restorative material has been introduced in 2009 which is known as 'bulk-fill' composite, in order to increase efficiency of the operator. However, many clinicians who have accustomed to the incremental cure philosophy when placing the light-cured composite quite rightly question what has been changed to make these bulk-fill light-cured composite a variable alternative. According to some researchers, bulk-fill composite offers more advantages compared to the layered composite. These include increased efficiency in working time, reduced polymerization shrinkage and reduces the risk of contamination and voids forming between the resins.
The aim of this study is to evaluate the clinical performance of bulk-fill composite as compared to the layered composite technique in class I and class II restorations over the period of 2 years.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Bulk Fill Composite
In the experimental cavity, Filtek Bulk Fill Posterior Restorative (3M ESPE) will be placed in 5 mm increments, eliminating the need for additional layers or multiple steps.
Filtek Bulk Fill Posterior Restorative
Filtek™ Bulk Fill Posterior Restorative is a one-step bulk placement solution for fast and easy posterior resin restorations.
Layered Composite
The control restoration will be filled with Filtek Z350 XT (3M ESPE) using the 2 mm incremental layering technique.
Filtek Z350 XT
Filtek Z350XT is a material for incremental layered composite resin restorations
Interventions
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Filtek Bulk Fill Posterior Restorative
Filtek™ Bulk Fill Posterior Restorative is a one-step bulk placement solution for fast and easy posterior resin restorations.
Filtek Z350 XT
Filtek Z350XT is a material for incremental layered composite resin restorations
Eligibility Criteria
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Inclusion Criteria
1. Any permanent premolar and molar requiring class I or II restorations;
2. Good oral hygiene;
3. Teeth in occlusion having at least one proximal contact with adjacent tooth;
4. Absence of any periodontal or pulpal pathology;
5. Absence of pain from the tooth to be restored;
6. Possible application of rubber dam during treatment
Exclusion Criteria
2. Smoking,
3. Pregnant patients,
4. Severe bruxism habit,
5. Pathological pulpal or periodontal problems,
6. Fractured or visibly cracked teeth.
ALL
Yes
Sponsors
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Melaka Manipal Medical College
OTHER
Responsible Party
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Asst. Prof. Dr. NASIL SAKKIR
Assistant Professor, Department of Conservative Dentistry and Endodontics
Principal Investigators
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Prof. Abdul Rashid Hj Ismail, BDS,MSc,DDPH
Role: STUDY_CHAIR
Melaka Manipal Medical College
Locations
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Melaka Manipal Medical College
Melaka Tengah, Melaka, Malaysia
Countries
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Central Contacts
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Facility Contacts
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Dr. Nasil Sakkir
Role: primary
References
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van Dijken JW, Pallesen U. Randomized 3-year clinical evaluation of Class I and II posterior resin restorations placed with a bulk-fill resin composite and a one-step self-etching adhesive. J Adhes Dent. 2015 Feb;17(1):81-8. doi: 10.3290/j.jad.a33502.
van Dijken JW, Pallesen U. Posterior bulk-filled resin composite restorations: A 5-year randomized controlled clinical study. J Dent. 2016 Aug;51:29-35. doi: 10.1016/j.jdent.2016.05.008. Epub 2016 May 26.
van Dijken JW, Pallesen U. A randomized controlled three year evaluation of "bulk-filled" posterior resin restorations based on stress decreasing resin technology. Dent Mater. 2014 Sep;30(9):e245-51. doi: 10.1016/j.dental.2014.05.028. Epub 2014 Jun 21.
Related Links
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Modified United States Public Health Service (USPHS) Ryge Criteria for Direct Clinical Evaluation of Restoration
Other Identifiers
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MMMC/FOD/AR/B5/ E C-2017(26)
Identifier Type: -
Identifier Source: org_study_id