| Abstract|| |
Background: Liners play a vital role in minimizing polymerization shrinkage stress by elastic bonding concept and increase the longevity and favorable outcome for composite restorations.
Aims: The aim of this study was to evaluate the clinical performance of nanohybrid composite restorations using resin-modified glass-ionomer and flowable composite liners.
Settings and Design: A single-centered, double-blinded randomized clinical trial, with split-mouth design and equal allocation ratio that was conducted in the Department of Conservative Dentistry and Endodontics.
Materials and Methods: In forty patients, a total of eighty Class I restorations were placed with resin-modified glass-ionomer cement (RMGIC) liner (FUJI II LC, GC America) in one group and flowable composite liner (smart dentin replacement/SDR, Dentsply Caulk, Milford, DE, USA) in another group. All restorations were clinically evaluated by two examiners, immediately (baseline), 3, 6, and 12 months using US Public Health Service modified criteria.
Statistical Analysis Used: Statistical analysis was performed using McNemar's test (P < 0.05).
Results: There was no significant difference in the color match, marginal discoloration, surface roughness, and marginal adaptation. Restorations with RMGIC liner group show 20% Bravo scores on anatomic form at 12 months but are still clinically acceptable.
Conclusion: Nanohybrid composite restorations with RMGIC (Fuji II LC) and flowable composite liner (SDR) demonstrated clinically acceptable performance after 12 months.
Keywords: Clinical trial; flowable composite liner; nanohybrid composite; resin-modified glass ionomer
|How to cite this article:|
Suhasini K, Madhusudhana K, Suneelkumar C, Lavanya A, Chandrababu K S, Kumar PD. Clinical performance of Class I nanohybrid composite restorations with resin-modified glass-ionomer liner and flowable composite liner: A randomized clinical trial. J Conserv Dent 2016;19:510-5
|How to cite this URL:|
Suhasini K, Madhusudhana K, Suneelkumar C, Lavanya A, Chandrababu K S, Kumar PD. Clinical performance of Class I nanohybrid composite restorations with resin-modified glass-ionomer liner and flowable composite liner: A randomized clinical trial. J Conserv Dent [serial online] 2016 [cited 2017 May 29];19:510-5. Available from: http://www.jcd.org.in/text.asp?2016/19/6/510/194030
| Introduction|| |
Increasing demands for esthetic restorations make composite as an alternative in direct posterior restorations. Composite materials allow “minimum invasive technique” and further reinforce remaining tooth structure. Clinical reliability and longevity of composite restorations in stress-bearing posterior teeth area depend only when these materials sustain polymerization stress. However, polymerization shrinkage poses a problem leading to volumetric reduction within the material at the restoration-tooth interference.,
Polymerization stress results in postoperative sensitivity, marginal staining, microleakage, gap formation, thus imposes its limitations in the application of direct restorations. Many techniques and newer materials have been introduced to reduce polymerization stress such as incremental layering technique, soft-start polymerization, and use of low modulus of elasticity liner as an intermediary layer between restoration and tooth structure.,
When the remaining dentin thickness is <2 mm, liners are usually applied for pulp protection. Glass-ionomer and flowable composite liners are commonly used between tooth structure and composite restoration. This technique is commonly known as sandwich technique.,
Recently introduced nanofilled composites have nanosized filler particles to increase weight percentage of composites. Nanofilled composites have certain advantages such as reduced polymerization shrinkage, increased fracture and wear resistance, and high polish and polish retention in stress-bearing areas. Tetric N-Ceram is one such nanohybrid composite which was introduced a few years back.,
Smart dentin replacement (SDR) material is a recently introduced flowable composite which can be used as liner in Class I and Class II restorations. SDR resin provides an approximate 20% reduction in volumetric shrinkage and almost an 80% reduction in polymerization stress compared to a traditional resin system.
GC Fuji II LC material, a resin-modified glass ionomer, can be used as a liner under the restorations, to reduce to some extent, the polymerization shrinkage stress of composite restorations. Basically, these liners either flowable composite or resin-modified glass ionomer provide better adaptation and act as a flexible stress-absorbing layer between restoration and tooth.
Randomized clinical trials are considered as a gold standard test for measuring the long-term performance of the materials in patients. Thus, the aim of this randomized clinical trial is to check the clinical performance of nanohybrid composite (Tetric N-Ceram) either with flowable composite liner (SDR) or with resin-modified glass-ionomer liner (GC Fuji II LC).
The null hypothesis of this study is that there is no difference in clinical performance of Tetric N-Ceram at 12-month period whether it is used with SDR/GC FUJI II LC liner.
| Materials and Methods|| |
This study was approved by the Ethical Committee (RC. No. NDC/PG-2013-14/EC/2014) and was conducted in the Department of Conservative Dentistry and Endodontics. This randomized clinical trial has been registered in the Clinical Trial Registry of India (CTRI/2015/02/005539).
Based on proportions detected by two independent groups, sample size estimation was calculated using a priori by G*Power 18.104.22.168 software (Faul et al. 2007). The minimum sample size of each group was calculated, following these input conditions: Power of 0.9 and P ≤ 0.05. To compensate for participants dropouts during follow-up, the sample size was set at forty restorations per group.
Therefore, forty patients with the following inclusion criteria were enrolled, patients with:
- Age group between 18 and 40 years who require at least two Class I restorations
- Good oral hygiene
- Normal occlusion
- Occlusal caries with the International Caries Detection and Assessment System score 4.
The exclusion of patients was based on the following criteria:
- Subjects with fewer than twenty teeth
- History of existing tooth sensitivity
- Known allergy to resin-based materials
- Pregnancy or breast-feeding
- Chronic use of anti-inflammatory, analgesic, and psychotropic drugs.
As it is a split-mouth design, the same patient received both liners. At the beginning of the procedure, a block of four numbers was chosen randomly from random number table. In the four-number table, if the first number that was chosen was even, then flowable composite liner was placed in the first tooth based on the order of the tooth and the other tooth received resin-modified glass-ionomer cement (RMGIC) liner. If the number was odd, then RMGIC liner was given to the first tooth and the other tooth received SDR liner. Finally, both the teeth were restored with nanohybrid composite.
All operative procedures were performed by the same operator. Before restorative procedures, periapical radiographs of the teeth to be restored were taken. Vitality tests were done using electrical pulp tester. After shade selection, the operative field was isolated with a rubber dam. Cavity design was restricted to eliminate carious lesion using #245 carbide bur (Diatech, Coltène/Whaledent) under constant cooling. Application of SDR liner (Dentsply Caulk, Milford, DE, USA), RMGIC liner (GC Fuji II LC, GC Corporation, Tokyo, Japan), and Tetric N-Ceram (Ivoclar Vivadent, Schaan, Liechtenstein) composite was placed according to manufacturer's instructions. Details of the materials used are summarized in [Table 1]. The composite material was applied using the oblique layering technique, with each layer not exceeding 2 mm. Each layer was cured for 20 s using the LED curing light unit (Bluephase c8; Ivoclar Vivadent AG, Schaan, Liechtenstein) with a light intensity of 800 mW/cm 2. The restorations were contoured using a superfine diamond bur (Diatech, Coltène/Whaledent) under an air-water coolant, and finally finishing and polishing of the restorations were done using Soflex discs.
In the present study, the primary outcome measure was the clinical performance of the restorations which includes functional and esthetic aspects. The secondary outcome measures were measured using modified US Public Health Service criteria for retention, color match, marginal discoloration, anatomic form, secondary caries, surface roughness, marginal adaptation, and postoperative sensitivity by two different evaluators. Both the evaluators did not know which liner was used in each tooth, thus provided the blinding of the evaluator. The evaluation was done at baseline, 3-, 6-, and 12-month period. The criteria of the evaluation for each outcome are detailed in [Table 2]. Any discrepancy between the evaluators in rating was discussed, and the consensus was reached.
|Table 2: US Public Health Service Modified Ryge Direct Evaluation Criteria Rating System|
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Statistical analyses were carried out between each outcome in between the groups at 3-, 6-, and 12-month time period using McNemar's test. Significant P value was set at ά <0.05.
| Results|| |
Totally, forty patients were recruited in the study with two restorations in each patient using two different liners which comprised eighty restorations. Of these, forty patients at 6-month follow-up, there was one dropout, and at 12-month time period, three dropouts were seen. The dropouts were mainly because of the relocation of the patients. Flow diagram of the trial participants is shown in [Figure 1].
In this present study, at 3-month time period, 40 restorations were evaluated in each group, whereas at 6 months, it was 39 restorations in each group and 37 restorations were evaluated at 12-month time period in each group. At 3-, 6-month time period, there was no significant difference in any of the secondary outcome measures in either of the group [Table 3]. After 1 year interval, there was a difference in scoring for surface roughness, marginal discoloration, marginal adaptation, and anatomic form. More ά ratings were recorded for these secondary outcomes in flowable composite liner group. Even though ά ratings were more, there was no statistically significant difference between the two groups and restorations are clinically acceptable.
|Table 3: Summary of the clinical findings of restorations using US Public Health Service criteria at the end of 1 year|
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| Discussion|| |
In the present study, the dropout ratio was only 5%, it does not affect the results of the present study. Many in vitro studies have shown that the flowable composite liners and RMGIC liners act as a stress-absorbing layer to decrease polymerization shrinkage stress. The concept of stress absorption varies with flowable composite liner and RMGIC liner.,,
In the literature, clinical trials of Lopes et al., Banomyong et al., Loguercio et al., and Burrow and Tyas  have evaluated the clinical performance of posterior composites at different time periods. In these studies, they have tested different types of posterior composites with different types of adhesive techniques and tested composites such as Prodigy condensable composite, Filtek Supreme XT, Filtek Z 250, and Filtek Supreme XT, and stated that there is no difference in the clinical performance of composites in the posterior restorations.
The present randomized clinical trial was designed according to the guidelines of consolidated standards of reporting clinical trials (CONSORT guidelines). The aim of this clinical trial was to test the clinical performance of nanohybrid composite with single adhesive technique but with varying liners. During recent years, nanohybrid composite is gaining popularity because of their advantages such as reduced polymerization shrinkage, fracture and wear resistance, and high polish and polish retention in stress-bearing areas.
The results of the present study have also shown that the clinical performance of the composite in relation to retention, color match, marginal adaptation, anatomic form, surface roughness, secondary caries, marginal discoloration, and postoperative sensitivity has no significant difference with SDR liner/GC Fuji II LC liner.
A randomized clinical trial by Banomyong et al. and Ernst et al. have stated that there is no difference in the clinical performance of composite with or without RMGIC liner/flowable composite liner.
In the present study, we have employed the study design with two different liners to test the clinical performance of composite, rather than with or without liner as the liners act as stress-absorbing layer to decrease polymerization shrinkage stress. Even our results have shown that there is no difference in the clinical performance of the restoration with RMGIC liner and flowable composite liner. The secondary outcomes such as marginal discoloration, surface roughness, marginal adaptation and anatomic form, and percentage of alpha ratings were more for the flowable composite liner. The more alpha ratings for these outcomes in flowable composite liner group do not have any significant difference in the results. The other secondary outcomes were retention, color match, postoperative sensitivity, and secondary caries; there was no difference in the alpha ratings of either of the groups.
A study by Burrow and Tyas  has stated that there is no significant difference in postoperative sensitivity of a composite restoration with or without RMGIC liner.
There was only a change in scoring with Bravo scores for surface roughness (5.4%), marginal adaptation (2.7%), anatomic form (5.4%), and marginal discoloration (2.7%) in RMGIC liner group, but this was not a statistically significant difference. All the restorations were clinically admissible.
| Conclusion|| |
Within the limitation of this study, it was concluded that the secondary outcomes such as retention, secondary caries, postoperative sensitivity, marginal adaptation, marginal discoloration, color match, anatomic form, and surface roughness were clinically acceptable for Tetric N-Ceram restorations with flowable composite liner and RMGIC liner.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| References|| |
Arhun N, Celik C, Yamanel K. Clinical evaluation of resin-based composites in posterior restorations: Two-year results. Oper Dent 2010;35:397-404.
Beck F, Dumitrescu N, König F, Graf A, Bauer P, Sperr W, et al.
One-year evaluation of two hybrid composites placed in a randomized-controlled clinical trial. Dent Mater 2014;30:824-38.
Al-Harbi F, Kaisarly D, Michna A, ArRejaie A, Bader D, El Gezawi M. Cervical interfacial bonding effectiveness of class II bulk versus incremental fill resin composite restorations. Oper Dent 2015;40:622-35.
Aggarwal V, Singla M, Yadav S, Yadav H. Effect of flowable composite liner and glass ionomer liner on class II gingival marginal adaptation of direct composite restorations with different bonding strategies. J Dent 2014;42:619-25.
Baracco B, Perdigão J, Cabrera E, Ceballos L. Two-year clinical performance of a low-shrinkage composite in posterior restorations. Oper Dent 2013;38:591-600.
Sampaio PC, de Almeida Júnior AA, Francisconi LF, Casas-Apayco LC, Pereira JC, Wang L, et al.
Effect of conventional and resin-modified glass-ionomer liner on dentin adhesive interface of class I cavity walls after thermocycling. Oper Dent 2011;36:403-12.
Hernandes NM, Catelan A, Soares GP, Ambrosano GM, Lima DA, Marchi GM, et al.
Influence of flowable composite and restorative technique on microleakage of class II restorations. J Investig Clin Dent 2014;5:283-8.
Güray Efes B, Yaman BC, Gümüstas B, Tiryaki M. The effects of glass ionomer and flowable composite liners on the fracture resistance of open-sandwich class II restorations. Dent Mater J 2013;32:877-82.
Dresch W, Volpato S, Gomes JC, Ribeiro NR, Reis A, Loguercio AD. Clinical evaluation of a nanofilled composite in posterior teeth: 12-month results. Oper Dent 2006;31:409-17.
Al-Agha EI, Alagha MI. Nanoleakage of class V resin restorations using two nanofilled adhesive systems. J Int Oral Health 2015;7:6-11.
El-Damanhoury H, Platt J. Polymerization shrinkage stress kinetics and related properties of bulk-fill resin composites. Oper Dent 2014;39:374-82.
Kasraei S, Azarsina M, Majidi S.In vitro
comparison of microleakage of posterior resin composites with and without liner using two-step etch-and-rinse and self-etch dentin adhesive systems. Oper Dent 2011;36:213-21.
Mahmoud SH, El-Embaby AE, AbdAllah AM. Clinical performance of ormocer, nanofilled, and nanoceramic resin composites in class I and class II restorations: A three-year evaluation. Oper Dent 2014;39:32-42.
Karaman E, Ozgunaltay G. Polymerization shrinkage of different types of composite resins and microleakage with and without liner in class II cavities. Oper Dent 2014;39:325-31.
Ozgünaltay G, Görücü J. Fracture resistance of class II packable composite restorations with and without flowable liners. J Oral Rehabil 2005;32:111-5.
Pecie R, Onisor I, Krejci I, Bortolotto T. Marginal adaptation of direct class II composite restorations with different cavity liners. Oper Dent 2013;38:E210-20.
Lopes LG, Cefaly DF, Franco EB, Mondelli RF, Lauris MF, Navarro JR. Clinical evaluation of two “packable” posterior composite resins: Two-year results. Clin Oral Investig 2003;7:123-8.
Banomyong D, Harnirattisai C, Burrow MF. Posterior resin composite restorations with or without resin-modified, glass-ionomer cement lining: A 1-year randomized, clinical trial. J Investig Clin Dent 2011;2:63-9.
Loguercio AD, Zago C, Leal K, Ribeiro NR, Reis A. One-year clinical evaluation of a flowable resin liner associated with a microhybrid resin in noncarious cervical lesions. Clin Oral Investig 2005;9:18-20.
Burrow MF, Tyas MJ. Clinical evaluation of three adhesive systems for the restoration of non-carious cervical lesions. Oper Dent 2007;32:11-5.
Jang JH, Park SH, Hwang IN. Polymerization shrinkage and depth of cure of bulk-fill resin composites and highly filled flowable resin. Oper Dent 2015;40:172-80.
Ernst CP, Canbek K, Aksogan K, Willershausen B. Two-year clinical performance of a packable posterior composite with and without a flowable composite liner. Clin Oral Investig 2003;7:129-34.
Department of Conservative Dentistry and Endodontics, Narayana Dental College and Hospital, Chintareddy Palem, Nellore, Andhra Pradesh
Source of Support: None, Conflict of Interest: None
[Table 1], [Table 2], [Table 3]